Effective treatment & side effect support | Innovations in breast cancer care

Turn your questions into confident choices

When you’re facing breast cancer, understanding your options can make all the difference. This series brings together leading experts and patient advocates to help you speak up for your needs, manage side effects, and navigate treatment decisions with confidence.

Each session includes practical takeaways, real-life insights, and a live Q&A so you can get the answers that matter most to you.

Transcripts

• Session 1
• Session 2
• Session 3
• Session 4

Session 1 | Lymphedema: Early action & long-term care

Caroline Koffke, RN, BSN, OCN (00:00:09):

Welcome, Dr. Gary. Thank you so much for joining us.

Monique Gary, DO, MSc, FACS (00:00:13):

Oh my goodness, Caroline, it’s so good to see you. Thank you for having me. Thank you all for joining. I’m just watching these numbers climb. People from really across the world who are tuning in to talk about this important topic and get some information.

(00:00:26):

Thanks again.

Caroline Koffke, RN, BSN, OCN (00:00:29):

Absolutely. We’re so thankful to have you here.

(00:00:32):

To start us out, I know you’re just a wealth of knowledge and we’ll show some more in your slides, but just give us a little bit of a background on what lymphedema is and the risk for those specifically with a breast cancer diagnosis.

Monique Gary, DO, MSc, FACS (00:00:44):

Sure. So lymphedema relates to fluid retention or fluid backup within the lymphatics. I’m going to show you some slides and a little diagram about it. But if you think about your lymphatic system like a spiderweb system under the skin, a very thin lattice, almost like lace, that drains infection and inflammation, proteinaceous fluid, so non-blood, non-bodily saliva, things like that. Right?

(00:01:10):

So every place in the body drains to someplace else. You get a head cold. It drains to the glands in your neck, and you get the swollen glands. Well, the breast and the arm drain to the glands or the lymph nodes under the arm. Understanding that helps you to understand why if you do a surgery, and you make cuts and you remove parts of that lymphatic system, you could end up with a backflow or a swelling as a result of interrupting that drainage system.

(00:01:39):

I tell my patients, you mess with the plumbing, you can get backup in the pipes. Right?

Caroline Koffke, RN, BSN, OCN (00:01:43):

Yes, absolutely. And that’s very, very helpful.

(00:01:46):

So speaking of you talking to your patients: As a breast surgeon, what do you typically communicate with your patients about lymphedema prior to surgery?

Monique Gary, DO, MSc, FACS (00:01:56):

You know, I typically will talk to my patients about the risk of lymphedema — the low risk of lymphedema — associated with what we call the sentinel lymph node biopsy.

Caroline Koffke, RN, BSN, OCN (00:02:06):

Mm-hmm.

Monique Gary, DO, MSc, FACS (00:02:06):

When we look to do a surgery. When cancer is invasive, meaning it broke out of where it started, the next question a patient will ask is how do we know it didn’t go anywhere else. So at the time of that surgery, we will give a little dye injection and it will go through the lymphatics to the first place that breast drains to, which is typically under the arm. And we’ll do a small incision and remove that very first lymph node.

(00:02:30):

So the risk of lymphedema in most modern studies is around 2% to 4%. The slide that I’ll show you has about 5% to 8%, and it really depends on the number of lymph nodes you remove and the size of the incision.

(00:02:43):

But we talk about, one, the risk of lymphedema being small. Two, the benefit of knowing your lymph node status because there’s a risk-benefit ratio. And, three, ways to assess for and ways to mitigate the risk of lymphedema. How do you know if you have it? Who are your resources? Making sure that there’s like a preoperative appointment to talk with our therapist about that so that you feel well-informed postoperatively.

Caroline Koffke, RN, BSN, OCN (00:03:12):

Great. That’s really, really helpful to hear.

(00:03:14):

Obviously you, as a standout, all-star breast surgeon, are starting these conversations with your patients. Not everyone might have that with their surgeon. And some people may be on the other side of this lymphedema journey, meaning that they’re already dealing with this. So I think segueing into your slides and taking a look at how we can monitor for lymphedema and what we can do if and when it appears, is going to be really, really helpful.

(00:03:43):

Let’s jump in, if you feel comfortable, to those slides. Then we can get some questions from the audience after you’re done your presentation.

Monique Gary, DO, MSc, FACS (00:03:51):

Absolutely. And I know someone put in there, I think it’s important to note that lymphedema can be present if you don’t have surgery. You are absolutely correct in that anything that blocks lymphatics can cause lymphedema, and that can include cancer cells blocking those lymphatics.

Caroline Koffke, RN, BSN, OCN (00:04:10):

Hmm.

Monique Gary, DO, MSc, FACS (00:04:10):

So we’ll talk about some of these things.

(00:04:12):

This picture on the top right is a diagrammatic depiction of the skin, and there are layers to the skin. Underneath and between those skin layers, there are lymphatics. This is that lace system, that doily or lattice system that I was telling you about. And you can see these little dots.

(00:04:31):

So this system of lymphatics is what drains, and when you look at the breast, the breast drains to multiple places. Most commonly it’ll drain to the armpit, or we call it the axilla. And there’s levels to this axilla. There’s level one, level two, level three, getting up into the shoulder, into the neck. And then there’s these internal mammary lymph nodes as well.

(00:04:52):

Anywhere where there are lymph nodes, this is where cancer can spread, because breast cancer typically, we call it lymphatogenous or lymphogenous, it’ll spread through the lymphatics as opposed to through blood or through other means like other cancers can.

(00:05:08):

When you get this accumulation of lymphatic fluid, it’s either because these could be blocked with tumor cells or because we’ve disrupted this pattern. And that swelling is not only associated with the breast, but also with the armpit and the arm. But it can also be associated with the breast.

(00:05:27):

We talk about who’s at risk for lymphedema, 5% or so. I quote, 2% to 4% of patients may develop lymphedema in their lifetime from the small procedure, the sentinel node biopsy, where we inject either around the areola or around the tumor to find out where’s the next station. You know, I’m a Philly girl. So if the train leaves the station, Where’s the next station? And we actually remove that at the time of surgery.

(00:05:54):

For some operations, for some patients, we have to end up doing not only the sentinel lymph node, but removing additional lymph nodes. And that’s called an axillary lymph node dissection. So when we do an axillary dissection, we’re taking all the level one and two lymph nodes, and that can increase the risk of lymphedema up to 20%. And I talk to patients about that.

(00:06:17):

These slides, this particular diagram was taken from MGH in Harvard, and they want to make sure that people understand that the vast majority of them relate to surgery, relate to radiation. I’ll show some information about that. And there are some risk factors, like being overweight. But some of those other risk factors have to do with the things that we, as a medical community, and treatments, things that we do to try to reduce the risk of cancer recurrence. So some of the taxane-based chemotherapies, elevated BMI, removing all those lymph nodes, radiation.

(00:06:51):

Regional lymph node radiation. When you get radiation to your breast, and not only to your breast but your armpit and your shoulder. That regional node radiation can increase the risk of lymphedema because it really does shrink and cause those lymphatics to become more fibrotic and sometimes more inflamed.

(00:07:09):

Increasing age is also a risk factor for lymphedema, and it’s one of the reasons why we’re starting to look at who needs axillary surgery, who needs radiation to their axilla. And there’s a lot more shared decision making regarding all those things. And you can see here that when we have to take all the lymph nodes and give radiation. So that’s advanced-stage disease, stage III disease, for example, where the cancer has left the breast and gone to your axilla. In those instances, you have to get radiation not only to your chest wall or remaining breast tissue but also to that shoulder and to the back and to the clavicle up here, that increases the risk of lymphedema as well. So a later-stage diagnosis is one of those things.

(00:07:55):

Somebody asked a question in the chat about the frequency of lymphedema and timing of lymphedema, and it depends on the surgery that you had. If you have an episode of lymphedema, you are at elevated risk for a recurrent episode. It doesn’t mean that it will happen again, but we do see that once you have experienced lymphedema, it becomes a chronic management condition. Patients who’ve had sentinel node biopsy are higher risk later on. They’re saying 3 to 4 years post-surgery. And this is why it’s important for, you know, at my cancer center, we see patients twice a year, really for that first 5 years. And they do have some appointments with our lymphedema prevention program so that we can identify who’s likely to be at risk, who’s got some questions, issues, concerns, whose measurements might be different so that we can try to to preempt that.

(00:08:52):

When we talk about screening, I know we’re going to get into a more nuanced conversation of some innovation in lymphedema detection, but there are different ways that we screen for it. In my institution, we have a program, lymphedema prevention program, a physical therapist who really specializes in the detection and management and patient counseling around lymphedema. And a lot of that you may be familiar with.

(00:09:16):

These arm measurements. You can see she’s got a tape measure, and they’re going to measure the wrist, the forearm, and the upper arm on the affected side, as well as the unaffected side. At Harvard, they’re using a perometer, measuring the arm volume. There are other ways as well.

(00:09:35):

We talked about the circumferential measurements. We talked about, a little bit, volumetric. You’ll see in some institutions, I think more globally than here in the U.S., they may submerge the affected limb in water, and then measure the displaced water volume.

(00:09:52):

We are going to talk a bit more about bioimpedance, not so much the spectroscopy. Actually, yes, we will talk about that, and the Sozo system that is useful to measure the actual fluid volume in the body. So we’re getting much more precise with how we’re measuring and detecting lymphedema.

(00:10:11):

There are imaging techniques that we can use. We can give a dye into that lymphatic system. And surgeons are more and more becoming familiar with and routinely using lymphoscintigraphy to try to visualize the lymphatics, identify blockages, identify the drainage pattern of the upper extremity, so that we can try to reduce the chances of our surgeries even causing lymphedema. CT scans I don’t think really provide a very good view of the lymphatics. It can show you fluid within the tissues and it usually is incidental findings with a CT scan.

(00:10:48):

Things that you might notice: pitting edema test. When you press in, does the thumbprint stay? Does it leave an indentation? Ultrasound could be used, fluorescence could be used.

(00:10:58):

There’s lots of ways to start to look at the lymphatics, but the reality is that early lymphedema doesn’t always have signs. And so when you go to your doctor to talk about these things or if you’re having a consultation, like a preoperative one, you’re with a family member and they’re talking about all the risks of surgery, some surgeons should mention lymphedema, and they should talk about the program they have for that. And if you say, “Well, what are some of the signs?” It could be swelling of the arm or hand.

(00:11:26):

You can see that, you know, stage for stage. Early-stage lymphedema, this is a 3% increase in swelling. How difficult is that to see compared to an 11% increase? You can see a little bit more fullness here. Compared to a 33% increase. Swelling of the arm or hand, heaviness in the arm, your jewelry is starting to get a little bit tighter.

(00:11:49):

I do counsel my patients about the immediate postoperative IV fluid causing swelling. So after surgery, you wake up. Let’s say you’ve had a mastectomy or something, and your fingers and your rings might be a little tighter. But you might have gotten more fluid than you normally would consume during that surgery. So in the immediate 24, 48, 72 hours after surgery, it’s typically not lymphedema. It’s typically related to fluid shifts and surgical fluid hydration, as you are in your recovery, tingling in the arm, the hand, the digits.

(00:12:25):

It’s important to note that lymphedema can occur not just in the arm and the lower extremity, but we can see lymphedema on the chest wall, in the breast, in the hand, on the back of the side of the body that was treated for breast cancer. And so if you have thick skin and swelling in any of these areas, those are early signs of some lymphatic congestion. So I don’t call it quite lymphedema. I call it maybe some lymphatic congestion that could ultimately lead to a more chronic lymphedema. S

(00:13:01):

Important to note, it does not always have signs. And that if you are offered an opportunity to meet with a lymphedema prevention therapist or a program, you really should consider it. Because I think as you build out who’s on your team — you’ve got your surgeon, you’ve got your oncologist, you’ve got all these wonderful folks — having therapists who can tell you what to expect, who can help you to assess for these things, who can give you recommendations regarding exercises and even compressive therapies, that’s an important component of your care and not an afterthought.

(00:13:35):

So if you’re offered that opportunity to meet with them, I do recommend that consultation. And it can be a scary one because this, on the bottom right, this is a scary thing to happen. You’ll see folks who have to end up wearing compression garments and things, but knowledge is power. If there’s one thing that we have learned, it’s really that when you know what to expect — you know, you don’t know what to expect in a cancer journey, but when somebody can tell you either what to expect, what to watch out for, things to look out for, or things to do to help improve them, that’s an empowering stance.

(00:14:07):

Some of the later signs of lymphedema, because we talked about the earlier ones, but late signs of lymphedema really would be things like having difficulty with your range of motion. If you can’t make a fist and close your fingers. You really can’t flex your wrist or your arm. If your skin is becoming increasingly thick. There’s a term for that, it’s called elephantiasis. Your skin’s starting to look like elephant. If you have poor wound healing, recurrent infections. These are all signs of later-stage lymphedema. And these are reasons to see not only your breast surgeon and your oncologist, but you may be referred to a plastic surgeon to look at some surgical management of these things.

(00:14:49):

The management of lymphedema, more often than not, it starts with conservative therapies that are something like we call it complete decongestive therapy. And there’s two phases, the active therapy and then the maintenance. The active therapy is what a licensed lymphedema specialist is going to do. And in my facility, we have them on the ground floor, and they will meet with you. They will assess: Do you have things like axillary cording? Do you have changes in the volume and the volumetric measurements of your limbs? Do you have decreased range of motion? And then they’re going to teach you how to do exercises at home so that you can do them at home during the maintenance phase.

(00:15:27):

This can be an uncomfortable phenomenon. And so I counsel my patients to make sure that they are looking at multimodal pain solutions, including things like acetaminophen, Tylenol, ibuprofen, heat, and cool compresses, things of that nature. And so it’s important to make sure that you are not limiting yourself, but that you work with a therapist who can tell you what’s safe for you to do at home.

(00:16:03):

All right, so, exercise. I have heard patients say, “They tell me not to exercise.” Exercise is one of the best things that you can do before surgery — I call it prehab — after surgery you can do your rehab at home or with a therapist. But it helps to promote healthy weight, it increases and encourages circulation, and that’s important.

(00:16:26):

Now that being said, I do not advise my particular patients to do rigorous upper extremity exercise immediately after surgery, because seromas can form. A seroma is a collection of fluid in the space that the body has made. If I remove some tissue, the body sees a space, and it will try to fill that space with fluid. You can end up with a bit of a golf ball underneath the arm. And that seroma may have to be either massaged it may need time, or it may need to be drained in the office. I may have to do a procedure and remove that fluid.

(00:17:00):

So I don’t advise rigorous upper extremity, like ellipticals, mowing lawns, vacuuming floors, et cetera, for the first 2 weeks after surgery. But thereafter, I encourage my patients to advance their activities as they’re tolerated.

(00:17:14):

Skincare. Monitoring for infections, making sure that you are moisturizing your skin, applying moisturizers daily, and being thoughtful, especially if you’re under consideration for radiation. You want to be careful about oil-based moisturizers prior to radiation. But before and after, in your morning, in your evening routine, it’s really important for cancer patients in general to pay great and close attention to your skin. Because all of the things that we do can really dry out that skin.

(00:17:47):

There are compression therapies, and you can find experts who can help you to manage the short-term swelling through compression sleeves like the arm sleeves, additional gauntlets and stockings for the hand. Those are more for long-term management. Patients may have to wear them daily for 3 weeks for up to 3 months even.

(00:18:09):

Advanced pneumatic compression therapy, these are compressive. They're sort of like the squeezers when you go right before surgery, or if you sit in one of those lovely massage chairs at the store and they kind of squeeze your ankles and make their way up your legs. Those are things that can help mimic the contraction and encourage the fluid movement. And then manual lymphatic drainage is a hands-on technique, and this is something that families can learn to do. You can work with a therapist.

(00:18:34):

And it isn’t all massage and relaxing. It can be a little bit rigorous. It doesn’t have to be, but sometimes it can be. But there is a certain and specific technique to lymphatic drainage and lymphatic massage. And I do encourage my patients to find those therapists and to utilize those services.

(00:18:58):

As I mentioned, there are stages of breast-cancer associated lymphedema. And you can see stage 1, maybe a little mildly swollen, but you kind of can’t tell. Unless you are really looking to see are there decreased veins in the hand. Like this one, you can sort of see. You can see the vasculature here in the wrist extending into the forearm that now seems to have faded away. So maybe just a bit of mild puffiness here compared to stage 2, where, you know, if you elevate it, the swelling goes down, and you press on it, and you may see a dent. Stage 3, this is really clinically elevated and the swelling doesn’t get better with elevation. You press on the area, and it no longer leaves a dent.

(00:19:42):

And then stage 4, you can see again this sort of elephantiasis picture where the skin looks wrinkled like an elephant. You can see sometimes nodules or warts, extensive scarring. The skin is thicker. It’s much more tough. These are people who have really decreased range of motion and quality of life issues.

(00:20:02):

So, always, always, always, our goal is to find, manage, and prevent lymphedema, but to treat lymphedema as early as possible.

(00:20:14):

When we talk about: What are we doing for this? There are doctors you may talk to who say, “Oh, the risk is so small, don’t worry about it.” But we know that the risk can be great. And the sequelae, the quality of life issues, can be tremendous for a person who has lymphedema. And so surgeons, especially, along with our plastic surgery colleagues, are starting to do more to investigate the causes of lymphedema from our surgeries and then look at ways to reconstruct.

(00:20:45):

This is a study that came out of Harvard. They’re injecting a dye into the lymphatics, and they’re looking at harvesting and replacing some of the lymphatics. We call it a lymphovenous bypass.

(00:20:58):

What we’re finding is, let me go to this picture. We’re finding that there are individuals who are at increased risk for lymphedema based upon the lymphatic drainage. And so now we can give dye and we can actually map and see, does your lymphatic only go one way and it goes down the arm into the hand or do you have multiple patterns of drainage from your armpit. Are you less likely to get that lower extremity swelling because you have multiple drainage pathways as opposed to just that one tricipital pathway where if this is disrupted, all the fluid’s going to back up.

(00:21:34):

That’s called reverse lymphatic mapping. Axillary reverse lymphatic mapping. We now can inject a dye that will travel through the hand, through the arm, into the axilla, and then we can inject a separate dye where we can now find the target lymph node. So we can see the ones we want and the ones we want to avoid.

(00:21:55):

Many academic institutions are starting to do this so that we can then avoid the post-surgical lymphedema because we now are able to see which lymph nodes we need to target and which ones we need to avoid. This is still somewhat, I’m going to call it experimental because it is not the standard of care. But I’m showing you this because I want you to know that despite the lower risk of lymphedema, because of the quality of life issues associated with it, we are continuing to invest in ways to identify who’s at elevated risk. What can we do to mitigate and manage that risk? And then what can we do on the diagnosis side of things to make things and make life easier?

(00:22:37):

You cannot prevent lymphedema, although we do call it a lymphedema prevention program. It really should be called a lymphedema risk reduction or management program. And one of the most important things you can do is to man maintain a healthy weight. It’s to make sure that your blood sugars are, if you’re a diabetic, your blood sugars are regulated, your A1C is within normal limits, because chemotherapy is a risk for lymphedema. Diabetes is a risk for lymphedema. Smoking, tobacco use, is a risk for lymphedema. And obesity, of course. So those are things that you want to try to manage the best you can.

(00:23:13):

Avoiding cuts in the affected arm. This is something that you do want to be considerate of, but you should not tailor your entire activity to these risk precautions.

(00:23:26):

And what I see most often in some patients is that they go to that lymphedema appointment and they come away with a list of do nots. Don’t do this, don’t do this, don’t do this. You can’t fly, you can’t garden, you can’t get your cuticles cut, you can’t do, and then they don’t know what they can do. And there’s a lot of fear surrounding that.

(00:23:44):

So yeah, wear gardening gloves, that’s important. Insect bites. You do want to limit yourself and wear sunscreen, wash your cuts, avoid allowing your skin to crack, wearing an SPF, et cetera. Those are important things. But there is no evidence that blood pressure readings, blood draws, injections, are going to cause lymphedema.

(00:24:04):

We do tell patients to preferentially use the other arm, but in patients who have bilateral surgery and patients who have venous access issues, if you need to use the limb, use the limb. You should avoid blood draws or blood pressure only if you have been diagnosed with lymphedema or have a history of lymphedema. And I think this is important to note.

(00:24:28):

There is strong evidence that exercise does not cause lymphedema. It actually improves lymphatic drainage. It improves circulation. Exercise is our friend, and it is one of the main ways to mitigate against cancer-related fatigue and side effects. So definitely do exercise. If you’re not sure what to do, how much to do, how much to push yourself, that’s where you need to see a physical and occupational therapist.

(00:24:55):

There is no evidence that lymphedema is caused by airplane travel. However, I tell my patients, you’re flying to Myrtle Beach — I’m in Pennsylvania — you don’t necessarily need to wear a sleeve. You fly into Scotland. Guess what? You probably should wear your compression socks. You may consider a compression sleeve for your upper extremity, more for your peace of mind than anything. Because you don’t want to be concerned that you have lymphedema. You should stretch your arm early and often, and this is based on surgical literature.

(00:25:24):

I think the lymphedema literature may still suggest that these are necessary things. I think that they are important tools in your toolkit. Flying long, long travel, that sort of airplane compression in the cabin, that cabin pressure, can push fluid down into the lower extremities, just as we see it in the arms and the hands. You fly, and you notice that your ankles are getting swollen. So it’s not a bad idea to consider. But there isn't evidence that if you don’t have lymphedema, that flying on a plane is going to cause it. That’s the point of this slide.

(00:26:02):

Saunas and hot tubs, I get a lot of questions about this. There is no evidence in the medical literature, that saunas and hot tubs are going to increase or cause lymphedema. There is one study that suggests that it may play a role in the development of lymphedema, but again, these are not really peer-reviewed, randomized controlled trials. I think if somebody wants to do a randomized controlled trial of people in hot tubs and saunas, sign us up. But be careful with things like folliculitis. You shave your legs, you get into a hot tub, that is a setup and a nidus for infection. So that’s really my concern regarding those sorts of things.

(00:26:44):

The last slide I’m going to show, and this really leads into our next topic, is that we are starting to see precision. Just as we have precision oncology, precision drugs, and tailored regimens, we’re starting to see some precision in symptom management of lymphedema.

(00:27:00):

One of my good friends is the the chief medical officer for a company called ImpediMed. And they have a Sozo digital health platform where you can get your L-Dex score. This is a much more empiric measurement, not just sort of, “Oh, well, we measured with a tape measure your wrist, your forearm, your upper arm,” but really what’s the fluid doing. What are the fluid shifts in your body? And how might that predict your lymphedema risk so that we could then develop a regimen for you even sooner, even before you start to see that swelling and everything.

(00:27:34):

I think it’s important for you to know that there’s a lot of hope on the horizon, that there are more precision ways to measure this, to manage this, than ever before.

(00:27:43):

And it is never too late for you to have a lymphedema appointment so you can meet with a lymphedema specialist at any time in your cancer journey. It doesn’t have to be, “Oh, I missed it during my preoperative appointments, and now I guess I can’t see a therapist about this.” This is always something that you can bring up.

(00:28:03):

Definitely focusing on your, your meals, your movement, your mindset, getting that body moving, paying attention and learning to listen to your body.

(00:28:12):

And the American Cancer Society is recommending, this is a lot of movement, 150 to 300 minutes per week, but the studies show even if you can do 30 minutes a day, even if you can only do 5 minutes of something that’s sort of high intensity. You’re in front of your TV or you’re watching this webinar and you’re walking in place. You get your two water bottles and you’re moving your water bottles up and down. I don’t know if you can see my arms here. This is moderate intensity. You walk a little faster, that’s high intensity.

(00:28:42):

Even 5 minutes of that a day can help to decrease the risk of recurrence, can increase circulation, can increase endorphins, can help from a cardiovascular standpoint, can decrease the risk of lymphedema occurrence as well. So definitely get moving, walking, dancing, those dance parties, hiking, biking, swimming, resistance, weights, yes to all of this. And this goes against some of the earlier teaching around lymphedema. We want our patients to move. We want you to lift weights, we want you to use resistance bands. We want you to stand, stand, stand.

(00:29:17):

Sedentary sitting is the new smoking. So we’re asking everybody to really increase the amount of daily movement and activity. Oh gosh, I snuck in a picture on my farm because that’s what we focus on here in Pennsylvania, the meals, the movement, the mindset, because that’s the stuff you can control.

(00:29:34):

So I’m going to stop sharing slides and I kinda want to take some questions, I think. We got some good activity going on in the chat here. I love it.

Caroline Koffke, RN, BSN, OCN (00:29:42):

Oh my goodness, Dr. Gary, that was so informative.

(00:29:47):

As a nurse, but on the medical side of things, I don’t get all of this information from surgeons. So I feel like I learned a lot through what you shared. So many great questions also.

(00:29:57):

I’ve been trying to kind of bucket them so we can hopefully hit a couple right now before we bring Keelin on to share her experience.

(00:30:06):

A common question has to do with just briefly the definition between cording and lymphedema and if there’s a connection there.

Monique Gary, DO, MSc, FACS (00:30:13):

That’s a great question. Cording is a manifestation of inflammation along the lymphatics. So think about it like your breast drains into your armpit, and then it goes down your arm. So guitar strings, if you can pluck and feel something that sort of feels like a guitar string in your armpit, that’s cording. Axillary cording is an increased risk factor for development of lymphedema, but it doesn’t mean you’re going to have lymphedema. It means that there’s inflammation in in the lymphatics that are in your armpit.

(00:30:45):

One of the things to do is just start seeing that therapist early. Because they’re going to do some exercises and stretching. It’s not going to feel good. This is not like the nice smooth massage, but they’re really going to give you some exercises to work out and to break up, as they say, break up those cords.

(00:31:03):

Chronic cording, cording that is not addressed, can absolutely lead to lymphedema. If you have it, if you see it after surgery, you must address it. Bring it up with your surgeon. If your surgeon’s like, “Oh, you know, it’ll go away,” bring it up to your navigator. Tell your navigator, “I might need to see a therapist about this.”

Caroline Koffke, RN, BSN, OCN (00:31:22):

That’s really helpful. Thank you for explaining that difference and the risk factors.

(00:31:27):

Another couple questions came in about location of lymphedema. Is it only in the arm? Can it be on the other arm? The breast? The legs?

Monique Gary, DO, MSc, FACS (00:31:35):

Ooh, so lymphedema can be anywhere in the body where there are lymphatics. And the whole body is connected like a subway system. That, that being said, if you have surgery in your armpit, you’re not likely to see lymphedema in your lower extremity, like in your leg.

(00:31:51):

You can see, though, and this is something that we don’t always address and recognize, lymphedema in the breast. And it usually manifests as thickness along the inferior aspect of the breast. That skin can be thicker, kind of like a grapefruit, you can see that pitting, et cetera. So lymphedema can happen in the breast, it can happen in the arm. It generally will not happen on the other side. It’s usually the affected side. So it’s very rare to do a surgery on one side and see swelling in the other hand.

Caroline Koffke, RN, BSN, OCN (00:32:21):

That’s really helpful information, and you just answered a whole bunch of questions there, so I appreciate that.

(00:32:26):

Next one, we had a couple questions about compression devices. So two individuals who have lymphedema want to know if they need to use their compression device daily, and then someone who does not have lymphedema wants to know if they should proactively wear a compression sleeve, et cetera.

Monique Gary, DO, MSc, FACS (00:32:45):

OK, let’s see. Let me start with the second question first.

Caroline Koffke, RN, BSN, OCN (00:32:51):

Mm-hmm <affirmative>. OK.

Monique Gary, DO, MSc, FACS (00:32:52):

So the second question was, if you don’t have lymphedema, should you wear a sleeve? And the answer is no. No, you do not have to.

(00:33:02):

Now, the only caveat I will add is if you’re going on long flights overseas, et cetera, if you plan to be on plane distances. Talk to your doctor and your team about this, but I generally say if you would wear compression leggings or compression socks on a plane, it’s not a bad idea to wear a compression sleeve or garment for your upper extremity. I say flights really over like 6 to 8 hours. Those are considerations.

(00:33:28):

The second question is the pneumatic pumps. They typically are used daily because that can help to manage the swelling and the symptoms. And what people don’t realize is that the symptoms are often subtle. You look at water and ripples and waves along a pond, you may not see a big ripple, but the fluid may truly be moving. So when you use that device daily, it is helping you to manage not just the swelling you can see but the swelling that could be building up over time that you don’t see until it’s swollen.

(00:34:03):

So yes, I do recommend daily use, and again, talk to your therapist about how often and how long you have to use it for.

Caroline Koffke, RN, BSN, OCN (00:34:10):

That’s very helpful, and explains the nuance of sometimes we can’t see this. When you showed that picture of the 3% difference in fluids, we can’t see that. And so if someone’s using that and not really seeing the difference, it might just be because we’re preventing and making sure that we don’t have a larger problem.

(00:34:28):

And I’m assuming that now that we have some better technology like that Sozo device, we can actually get some more specific readings. I know Keelin will share her experience with that as well.

(00:34:39):

Another question that I think you may have mentioned briefly in the slides. Can lymphedema be painful? We have some individuals who are still experiencing a lot of pain in the breast and axilla. Obviously that can be multifactorial, but could it be a sign of lymphedema?

Monique Gary, DO, MSc, FACS (00:34:56):

It can be. And it is, as you said, multifactorial. So there’s a couple things there.

(00:35:02):

One, after axillary surgery, the nerves that run from the armpit to the skin and that give you that sensation under the arm here can be cut. A lot of times you can feel sort of numbness here, you can feel very hypersensitive here. That hypersensitivity is not necessarily a sign of lymphedema, that has more to do with the cutaneous or the skin nerves that were cut and that are regenerating during your healing process.

(00:35:26):

When you feel tenderness in the breast after radiation, radiation itself can cause some sensitivity in the skin and can cause lymphedema. Meaning fluid retention within those skin layers. And as that builds up, that does many times feel tight, it can feel tender. So yes pain is more of, I’m going to say, a consequence of rather than a symptom of lymphedema.

(00:35:52):

But yes, if you’re having unexplained swelling, tenderness, things like that, you have to make sure, one, you get checked out for things like inflammatory breast cancer, do not assume that it is lymphedema. Make sure that your doctor has ruled out inflammatory breast cancer, which can manifest as very thickened skin, red skin, we call it “peau d’orange,” peel of the orange. If you have orange peel skin and it’s new to you, that’s something to not make an assumption about.

(00:36:18):

I would say, yes. It can result in tenderness, it can be a symptom of especially later stage lymphedema, but there’s a couple other reasons why you might have that tenderness as well.

Caroline Koffke, RN, BSN, OCN (00:36:29):

That’s really helpful. Thank you.

(00:36:32):

I’ll ask one more question before we bring Keelin on. Do you see a difference in lymphedema risk with the type of reconstruction that someone chooses?

Monique Gary, DO, MSc, FACS (00:36:44):

That’s great. It is a tough one. I’m going to say I see, in general, less lymphedema in breast conserving surgery because more of the entire lymphatic pathway is left intact. If you do a lumpectomy and you take out one or two lymph nodes as opposed to a mastectomy and removing eight to 10 to 15. I saw somebody in the chat said they had — whoa! — 41 lymph nodes removed. My goodness. That risk is much higher.

(00:37:19):

I think the difference between lymphedema with implant-based reconstruction versus like DIEPs and autologous flaps using your own tissue, I don’t know of any studies that have really looked at that. I’m just not aware of that literature. But what I can tell you is that doctors are now trying to figure out how to reconnect lymphatics in those instances.

(00:37:43):

So if you’re going to have that DIEP reconstruction, which oftentimes is delayed. Or you maybe had a failed reconstruction. Maybe your implant got infected or it just didn’t do well, and now you have to do the autologous, moving the fatty tissue into the breast. They’re starting to look at can we map the lymphatics and can we decrease lymphedema for those patients.

(00:38:03):

So I would say there’s probably a slightly higher increased risk of lymphedema when you have the deep inferior epigastric perforator, or the DIEP flap, reconstruction.

(00:38:13):

I noticed that somebody in the chat asked about swelling in the legs. So there are lymphatics in your abdomen as well, into the groin. Generally speaking though, when you see people who are like on chemotherapy treatments, that could be a protein issue.

(00:38:27):

So seeing swelling in the legs as a result of breast cancer treatment may have a lot more to do with your protein stores than cancer blocking the lymphatics. But it certainly is a possibility. Be mindful of the fact that it isn’t always ... everything isn’t always lymphedema, and making sure that you’re getting good protein. That’s why I brought this up, because making sure that you are having, as best as you can, excellent nutrition that focuses on reducing that swelling, making sure that your heart is OK, you don’t have congestive heart failure. That’s another reason that you might see increased fluid in your lower extremities, increased tightness in your fingers, and all. There’s sometimes some other reasons besides lymphedema.

Caroline Koffke, RN, BSN, OCN (00:39:12):

And I think that’s incredibly important to highlight. A lot of the things that you have mentioned stem back to go talk to your provider, have them do some tests. Do you need a skin punch biopsy? Do you need to see a specialist to work this up to see is it lymphedema? Is it potentially something else? Because it could be so many different things.

(00:39:32):

Let’s bring Keelin on though, because I would love to have her kind of share her experience as a patient advocate who has some experience with lymphedema. So, Keelin, give us a brief intro of yourself, and then I have some questions for you.

Keelin McDermott (00:39:51):

Sure. Thank you, Dr. Gary. That was super insightful to see all of the diagrams and really understand what is happening.

(00:40:00):

My name is Keelin. I am 28 years old. I was diagnosed with stage III breast cancer at age 26, so 2 years ago. I moved home and received treatment in Northern Virginia, but I’ve since moved back to Charleston, South Carolina. And I am managing my lymphedema with a mix of a physical therapist and at-home management, and just navigating the survivorship of breast cancer, especially at a young age.

Caroline Koffke, RN, BSN, OCN (00:40:35):

Well, thank you so much for joining. You are a wealth of knowledge, and we have worked with Keelin previously and really appreciate her insight.

(00:40:42):

So, Keelin, tell us a little bit about what your care team shared with you about lymphedema prior to your surgery.

Keelin McDermott (00:40:50):

Sure. My breast cancer was isolated on the right side. I knew, especially after the first biopsy, we knew that it had reached the lymph nodes. So I was educated very early with my care team on not only the risk, but my care team did a very great thoughtful, you know, they took the time to educate me on lymphedema, not just rush into all of the risk and possibilities. They really educated on what it meant and shared diagrams with me so I could fully understand what it was, what I could look out for, and how every step of my journey might impact the risk of lymphedema. I did undergo two surgeries and had a handful, a little over I think 12 or 14 lymph nodes removed out of my right armpit. So did the auxiliary lymph node removal.

(00:41:48):

I was really educated first. Along with the education, they proactively took the initiative to take a baseline. At my hospital they did have the technology to measure the amount of fluid in my arm prior to my first surgery. The education and then taking baseline and measurements was super important and imperative with my journey. They took the time, before this first surgery, and really educated me on what to look out for.

(00:42:26):

And then before my second surgery, we looked at other techniques that we could apply possibly to surgery to lower the risk. So I did complete a lymphovenous bypass surgery during my second surgery. And then following that surgery we knew I was going to go into radiation. So the conversation was ever changing and really just catered towards what is next on my journey and what to look out for.

(00:42:55):

We took it in like small chapters, I think, because it was something that was ever changing with just navigating what my journey looked like.

Caroline Koffke, RN, BSN, OCN (00:43:04):

That is incredibly helpful. Dr. Gary, anything that you would add, I know we talked about this briefly in the beginning, but that you prepare your patients for in advance?

Monique Gary, DO, MSc, FACS (00:43:15):

Yeah. I do try to counsel about what to expect after surgery. But even before we get there, I really try to make sure that they understand the relationship between the breast and the lymphatics. The fact that, based on the number of lymph nodes we remove and a lot of other factors, the risks for lymphedema. But just communicating with me early. Letting me know what’s going on so that we can start to address these things early.

(00:43:40):

And I love that you said you got a lymphovenous bypass. We are able to really kind of reconnect the lymphatics, which drain into the bloodstream. Somebody asked that question in the chat. And I typed an answer. The lymphatics ultimately drain into the bloodstream. And so one of the ways that we look at a treat lymphedema is that we’re able to take these little tiny vessels that are tinier than vermicelli noodle. They’re spiderwebs, four strands of hair thick, and really start to combine them back into the veins. And that allows for that drainage to go back into circulation. There is hope, and I think that’s what I really hear from your message, Keelin, is that there is a lot of hope around managing and living with lymphedema when we know early and we speak up about it, we assess it.

Caroline Koffke, RN, BSN, OCN (00:44:28):

So helpful. And that actually segues really nicely into my next question for you, Keelin. I have prefaced this, but did you experience lymphedema symptoms postsurgery?

Keelin McDermott (00:44:40):

Yes, I did. I think it’s important to note that, to Dr. Gary’s presentation, there’s different stages. It can be subtle or it can be,really noticeable. For me, I was really proactive in listening to my body. Like most of us, when we are going through a journey like this, I knew I had to really listen to my body and know that no symptom was too small to bring up in conversation to my care team, across all members of the care team.

(00:45:16):

So I began noticing just a sense of ... for me, it was an unusual sense of bruising, sort of a bruising feeling on my right arm. Little acts of movement that I didn’t expect to make my arm feel tired or was feeling tired, like reaching for something in the microwave or the repetitive motion of folding laundry. There were things that right after I would do actions like that, my arm would feel really heavy or tired.

(00:45:49):

And I knew the risk. I just was expecting swelling or my jewelry to stop fitting. So it was something that I really had to tune in and be like, OK, something’s not quite right. I’m just feeling really tired, heavy on this arm. And then the sense of bruising without showing bruising. I later learned that it was an inflammation and cording developing across a certain area of my arm. But those symptoms, I immediately communicated it to my whole team via MyChart, or if it happened to fall on an appointment, I brought it up immediately and just really advocated for myself that something didn’t feel right. Can we go back to the measurements? Can we go back to the technology that we have and really try to identify what could have possibly changed over the time of my first measurement between the first and second surgery, et cetera.

(00:46:50):

Those were some of the symptoms I experienced. It was mostly just the repetitive movements became really exhausting for my arm. I was just really expecting those images and what you learn about and look for a completely swollen limb. But in my case, that wasn’t the initial symptom of my lymphedema. It really became like an internal feeling.

Caroline Koffke, RN, BSN, OCN (00:47:20):

I think that’s really important to highlight as well, that this can look and feel so different. And I know obviously Dr. Gary highlighted some of those early symptoms, but the bruising and advocating right away with your care team, especially to get some updated measurements, I think is paramount.

(00:47:38):

Dr. Gary, anything to add to that?

Monique Gary, DO, MSc, FACS (00:47:43):

I think the only thing I would add is that the plastic symptoms may not be your symptoms. And so this is what she’s saying exactly, is that something felt different. It felt off for me. It felt like just too much fatigue for too little movement. I did a few things. All of a sudden it’s just heavy and something is off for my level of activity and my norm.

(00:48:06):

And that’s sometimes hard for doctors to hear because you may not fit the classic mold of these sorts of things, but bringing it up and noting when did it happen, what made it better. Is this every time you vacuum the floor? OK. And you put your arm up and it gets better? Now I’m getting a picture of what’s going on. And so you becoming the investigator of what’s happening with you and bringing as much information as you can to the table is really, really helpful so that we can help to advocate for you and help to tease out what might be going on.

Caroline Koffke, RN, BSN, OCN (00:48:38):

That’s great to bring up. And I think we always highlight that you are the expert of your own body. If something does not feel right to you, it is definitely worthwhile to bring these up.

(00:48:49):

Keelin, after you brought this up to your care team, what were the next steps for you? I know you’ve had quite the journey.

Keelin McDermott (00:48:55):

We went back to my baseline measurements. We retook all the tests that I underwent prior to my surgery. I was able to identify lymphedema mostly through the Sozo machine that measured the fluid. We were able to identify that my measurements were nearly symmetrical across both limbs, but it wasn’t until that fluid machine was able to measure and record that the amount of fluid in my arm had fluctuated up on the right limb.

(00:49:30):

With that understanding, that there indeed was more fluid in the arm, we had to act very quickly. And that was, once we identified that, my care team ... I found a physical therapist, they referred me to a physical therapist, that was the word I was looking for. Refer to a physical therapist who was a specialist in lymphedema management.

(00:49:58):

Those appointments have very much changed from the very beginning of when I was diagnosed with lymphedema. My first few appointments, as Dr. Gary explained, it wasn’t super pleasant. It wasn’t that lymphatic spa feeling of an appointment. It was really working my arm and identifying the cording and identifying those blockage areas and how the arm felt different week over week. And really just learning, What can I do? What should I be doing? Where do I begin?

(00:50:36):

I think a physical therapist was the best person to teach me. Little stretches, send me home with bands so I could do exercises. The simple, sleeping. The way I slept, I lifted my arm up while I was sleeping. It was a lot of trial and error, I would say, to figure out what was helping and what felt good for me.

(00:51:04):

I did immediately do some compression garment measurements, and I ordered a hand glove, which I still wear today, as well as a compression sleeve. Because I am active, I’m in office, I’m sitting, trying to get up and move every day. But I had that daily wear.

(00:51:26):

It was really trial and error in the sense of, I got compression sleeves and then I got at-home wraps. Like I would wrap my arm at night. I would, on bad days, add foam. Sometimes that wouldn’t work 1 week, and I’d say, “OK, this isn’t quite working. How do we change it up? What other stretches should I be doing?” And then we would add different ...

(00:51:50):

I definitely in my walks now, I do movement over my head. I like do these over my head to get the movement. I learned how to do manual lymphatic drainage. But I would say, I see a physical therapist every week and that appointment looks different every week. It’s not the same. Things can change overnight or even in hours. Like I woke up this morning, my hand wasn’t quite swollen, but a few hours later I added this glove.

(00:52:24):

So I think my physical therapist really educated me with at-home management. But at my stage I needed that extra management with a physical therapist to really work it and push through some of the cording and scar tissue and be that extra two hands on my arm.

(00:52:45):

And it was great to also do progress reports with her. What, week after week, what have I been doing that maybe has reduced the measurements or reduced the Sozo machine fluid measurement. So I think the physical therapist was really crucial to me. And then always communicating my own progress of how I feel to her so we could record it in the notes and then that can be communicated with the larger care team.

(00:53:15):

I think I did a lot, and it was a lot of trial and error. It didn’t come easy. One garment didn’t solve it for me. It all has been super different week over week.

Caroline Koffke, RN, BSN, OCN (00:53:26):

And I think that’s really important to highlight. And it’s also important to highlight that you were diagnosed 2 years ago and you’re still having, obviously surgery wasn’t two years ago, but you’re still having weekly appointments with your P.T.

(00:53:39):

As Dr. Gary mentioned, this is a chronic condition, and you’re still working at it every week. Important to highlight that. And then hopefully with some of these new technologies, we can get to a point where, where it isn’t so chronic. But thank you for sharing that.

(00:53:57):

Dr. Gary, anything to add as far as kind of some of those post-action steps?

Monique Gary, DO, MSc, FACS (00:54:02):

Yeah, I think, you know, always asking your team, What do I look for at home? What should I do? When am I safe to do things? And the answer is not always going to be fixed because everybody heals differently. And so it really is monitoring how I feel. “You know what, I’m 2 weeks out of surgery and now I’m able to ...”

(00:54:19):

I tell my patients immediately after, we’re shrugging. We’re shrugging shoulders, we’re moving our neck, we’re keeping, because everything’s tight. You’re all kind of drawn like this, and that impacts your circulation, it impacts your muscles, it impacts your pain. And so making sure that you are doing things immediately postoperatively to stretch as best as you can and to gradually slowly increase those movements and everything is very, very important.

(00:54:47):

Many of us have toolkits, we have pamphlets and books that we give out that helps people to know week 1 after surgery, what are you generally safe to do. I think having that sort of a primer. And if your doctor doesn’t have one, LBBC’s got resources. They got resources aplenty of what you should do as far as your postoperative your movement and things to watch for at home. We might think about doing a little toolkit, checklist, or a little symptom tracker of some sort actually might be helpful to create.

(00:55:20):

But yeah, I think that’s it. And just knowing that it’s normal to feel uncomfortable. It’s normal to feel a little tight. But as you are now, 3 weeks, 4 weeks, 5 weeks, 6 weeks out of surgery, “Hmm, you know what, there’s some things I need to, to maybe talk to my doctor about because I’m still having these symptoms. They haven’t gone away yet.”

Caroline Koffke, RN, BSN, OCN (00:55:42):

I think. Yeah, that’s absolutely accurate and so important.

(00:55:47):

A really quick question for you, Dr. Gary, and then I have another one for you, Keelin. As far as monitoring, whether it’s with the Sozo machine or with something simpler in the office. How frequently, if someone has lymphedema, should they be getting that monitoring?

Monique Gary, DO, MSc, FACS (00:56:05):

So Sozo is typically done quarterly, I think. So like every couple of months. It can be more depending on what the concern is. But generally speaking at least twice a year. But I see many practices doing it on a quarterly basis.

Caroline Koffke, RN, BSN, OCN (00:56:20):

OK, great.

(00:56:22):

Keelin, obviously you’ve tried many, many things. Is there one thing that you have found to be most helpful for you? And I know you said it changes every week, so might not be an easy answer.

Keelin McDermott (00:56:33):

Yeah, I think the regimen that I have found that works best with me right now is finding that balance between comfort and efficiency. I think for me, there were some night garments that I tried. Sleep is really important to me. I enjoy my sleep. And I think there are some nighttime garments that were just too constricting. It just was really uncomfortable. So for me, I found that, while those might be super comfortable for someone else, at night, it was most comfortable for me to just manually wrap my arm and add foam, like a little foam wrap on the hand or the forearm where I needed that extra pressure to sort of push the fluid up.

(00:57:23):

These have become things that I just carry in my backpack or have in my office in case throughout the day it’s starting to feel a little heavy. I can wrap this and just do it quickly. It wasn’t the first time that I could do it on my own. I had help. A physical therapist how to teach me how to properly wrap this. Now I am pretty good at wrapping it on my own. But this is something that really, I can’t have too many of these around my house. We are always rolling them, it feels like, or finding little clips in our rooms, in our house to keep them intact on my arm. But these have been super great for me. If I know I’m going to be active or traveling, I will use something. Like if I’m traveling, I’ll wear this with the full sleeve, or if I’m playing any type of sport, I’ll definitely lean into these garments like the Juzo garment. I’d say these two have become things that I sort of interchange. I recently have gotten a new knit garment that seems to be a little more comforting at night.

(00:58:43):

Having lymphedema is, it’s timely, it’s a management. It’s a routine that you have to carve out time. For me it was another appointment. It was, “I’m too tired to do this.” But I think I really just learned the importance of I feel a lot better when I do some of these. So carving out those extra 5 to 10 minutes to just do this at night and then take it off in the morning and rewrap it.

(00:59:10):

I definitely would say these wraps. There’s a lot out there.

(00:59:13):

I have definitely tested a lot. I think, more noticeably in the last few months, it’s become less of swelling in my arm. It’s sort of moved down to my hand. I don’t know why. But I’ve learned how am I going to manage that swelling in the hand better.

(00:59:36):

I also educate myself through different platforms and channels or like blog posts. So I went to my physical therapist and I said, “It’s swelling in my hand. It’s getting hard to hold or write, and it’s uncomfortable. What else can we do? Because what I’ve been doing is not working anymore.” So we’ve tried K tape on my arm, just sort of wearing tape down my fingers and then wrapping over to the wrist. And that has seemed to work for my daily, my days at my office when I’m at the computer all day.

(01:00:09):

So every day’s different. I think it’s time management, giving myself the time to know that I have to deal with my friend lymphedema. And it might be different today than it was yesterday. So really just preparing and having that toolbox and all of the different ways of managing it. Bcause it certainly changes throughout days and activities. Yeah, just learning and giving patience.

(01:00:40):

I think for me it was, it was really frustrating. It was like, I’m doing this for 2 weeks and it’s not working. Or, you know, it’s something that you just had to be really patient with yourself and give yourself the grace that you’re going to have to do trial and error and it’s just finding that balance of comfort and what feels good to you because it might not be what feels good to me.

(01:01:07):

There’s a lot out there. So willingness to try and optimistic that hopefully you can find your balance between management and comfort.

Caroline Koffke, RN, BSN, OCN (01:01:17):

That’s so helpful. Thank you.

(01:01:19):

And I think it’s also so important to note that these physical therapists that specialize in lymphedema, this is what they’re seeing and working with every single day. And so they can help you build that toolbox even better than some of your other providers.

(01:01:34):

Dr. Gary, anything to add there?

Monique Gary, DO, MSc, FACS (01:01:36):

Yeah. Keelin brings up a really good point, which is that it isn’t always the same. So knowing what to look for means knowing your normal, because sometimes swelling could be in your upper arm, it could be at your elbow. It could be, you know, this is not, it jiggles a little bit but now something is going on here or now it’s in my wrist. And so I think it’s important to know, as you think about and understand the lymphatics, the body is connected. It’s an entire network. It’s a subway system, if you will. And so there can be different manifestations of lymphedema. So paying attention to that and finding ways to manage that.

(01:02:11):

And someone else put in the chat, I think it was — I don’t want to call anybody’s names during the webinar, but really great advice on when to wear your sleeve and gauntlet. A lot of people do it during sleep, when they elevate, and that way during the day they kind of notice that things fill up. And at night they sort of push it all back into circulation. But it’s going to be different for everyone.

(01:02:31):

And also nutrition, decreasing the amount of inflammatory foods and looking to, you know, there’s no one right diet or anything for, certainly for cancer risk reduction and risk of recurrence. We’ve talked about things like the Mediterranean diet. But an anti-inflammatory diet. Foods that do not cause or create more inflammation in the body are things that can definitely help with the lymphedema process and with that management. So yeah, really important things to consider.

Caroline Koffke, RN, BSN, OCN (01:03:00):

Thank you for that. Dr. Gary, a few other questions here. We had two questions about well, one was red light therapy and then similarly infrared saunas with lymphedema. Any advice on avoiding or using those things?

Monique Gary, DO, MSc, FACS (01:03:17):

Still experimental. So there are some early studies looking at infrared light to support and reduce lymphedema. It makes sense that it potentially could. Like light therapy should probably be a thing. But again, there’s not a lot of long-term studies on it. So I would say you have to talk to your team about it.

(01:03:39):

In general, things that help to decrease inflammation and decrease toxins. Things that help detox, et cetera, are not a bad thing. But hot tubs, for example, someone else put in the questions, they’ve got stage 2 lymphedema. If you’ve already been diagnosed, those might not be the right things for you. So definitely talk to your team about them. But things that help to increase circulation, decrease the amount of toxins in the body. It stands to reason that there could be some benefit there. But again, very experimental, and I’m not endorsing them.

Caroline Koffke, RN, BSN, OCN (01:04:08):

OK, thank you.

(01:04:10):

One last question for you, Dr. Gary. Someone asked, they have lymphedema. It’s really hard for them to get to treatment. It’s very far away. It’s not super accessible. Besides their own comfort and kind of aesthetic of having that lymphedema, is there an actual medical reason that they should want to get rid of the lymphedema, whether it’s from a cancer perspective or just moving the lymph? Or is it really just their own comfort?

Monique Gary, DO, MSc, FACS (01:04:37):

No, there is a medical or clinical detriment to having lymphedema. Because it can become more progressive. Stage 1 lymphedema is a nuisance. Right? You can live with it. You might notice that, “OK, I don’t see the veins as much.” Stage 2, all right, my arm’s heavy and I just can’t ... I can vacuum, but I can’t vacuum and garden. But as you get into stage 3 and stage 4 lymphedema. And it’s not to minimize the symptoms of any of that, for sure.

(01:05:02):

But as you get into stage 3 and 4, you run the risk of venous stasis ulcers. You run the risk of infections. Your skin starts to change, the integrity can change, and you’re at increased risk for infections that can cause health, issues and your quality of life decreases.

(01:05:21):

I think it’s something to be under consideration for, to monitor for. If it’s well controlled and compensated, you don’t necessarily have to continue to pursue some treatment for it, but somebody should be kind of checking in with you about it to make sure that it isn’t becoming more progressive.

(01:05:38):

This is, again, that chronicity of the relationship with your oncology team. Not just your surgeon, not just your oncologist, but all of these therapists who help to make sure that your survivorship is as full and robust as it can be. Because lymphedema is one of those things that can kind of chip away at your survivorship and be an issue bigger than it than we’d like for it to be. So having a good plan in place, checking in with your body daily, having some tools to address it and feeling good about that plan is all part of your survivorship care plan.

Caroline Koffke, RN, BSN, OCN (01:06:12):

Thank you so much. That is so helpful to hear and closes this out really nicely with the information that you’ve both shared with us.

(01:06:20):

Thank you so much, Dr. Gary, for sharing your expertise and, Keelin, for sharing so much of your personal story and your journey. This was a great discussion with a lot of helpful information.

Session 2 | The right dose for you: Managing treatment & quality of life

Caroline Koffke, RN, BSN, OCN (00:10):

Welcome, Dr. Sammons. Thank you so much for joining us. Ooh, and your cat, even better! Matches your outfit too. That’s perfect. Very well planned.

Caroline Koffke, RN, BSN, OCN (00:22):

We’re so excited to hear from you, so I will let you jump right into your presentation.

Sarah Sammons, MD (00:26):

Great. Hello, everybody. Happy to be here.

Sarah Sammons, MD (00:30):

This is possum in my lap. I’m working from home today, and she is very excited to talk about The right dose: Managing treatment and side effects.

Sarah Sammons, MD (00:42):

Just to tell you a little bit about me, I am a breast oncologist currently at Dana-Farber in Boston, Massachusetts. I saw some folks from North Carolina. I was at Duke for 7 years prior. I treat women with all stages of breast cancer.

Sarah Sammons, MD (00:59):

This is an incredibly important conversation. I think we could talk about side effects, side effect management and dosing for hours. Today we’re going to talk a lot about dosing and dose reductions and how dose reductions might impact side effects. But then at the end, in the Q&A, we can talk a little bit more about specific questions about side effect management that you might have outside of dose reductions. And maybe we’ll have to have you in another session about just managing different types of side effects.

Sarah Sammons, MD (01:40):

Today we’re going to talk about the dosing of breast cancer medications, both in the early stage and advanced stage. And we’ll talk about, just educate you a little bit on how physicians and companies decide what dose patients should get, usually starting in the advanced or metastatic setting, which then that dose generally moves into the early-stage setting.

Sarah Sammons, MD (02:01):

And then we’re going to talk a lot about what I hear about in clinic. There’s no question that dose reduction can help with side effects. There’s just absolutely no question about that. But a lot of times my patients say, “OK, well, but if I dose reduce, is that going to impact my outcome? Is that either going to impact my chance of cure or my chance of this therapy working for a longer period of time?” So we’re going to go over a lot of that data too, because I think it’s just important to educate you so that you can bring this back and talk to your teams.

Sarah Sammons, MD (02:39):

In terms of an introduction, the dose of a medication is obviously how much of that medication that you take, whether that’s oral, whether that’s injection, whether that’s intravenous chemotherapy. It’s also how often you get it. So maybe you take the drug every day, maybe you take it 3 weeks on, 1 week off. Maybe you come in for IV infusions weekly or every 3 weeks.

Sarah Sammons, MD (03:05):

Dosing also has to do with how long you take it. So in the early-stage breast cancer setting, generally we’re using therapies for a finite period of time. If it’s HER2-targeted therapy, we give that for a year. If it’s endocrine therapy, you might be on that for 5 or 10 years. But in the advanced setting we generally give therapies as for as long as they’re working. And sometimes, fortunately for most patients, that could even be years. And so that’s where tolerability and, and dosing really, really gets tricky and is hard for patients.

Sarah Sammons, MD (03:44):

The goal, whether it’s early-stage or advanced-stage breast cancer, is to maximize your outcome. If it’s early stage, we want to increase your chance of cure. If it’s advanced stage, we want to prolong the amount of time that you’re going to be on that medication until the cancer grows. And we want to prolong your life for absolutely as long as possible.

Sarah Sammons, MD (04:04):

That’s the goal for the vast majority of people. Some people have different goals, which are quality of life only based.

Sarah Sammons, MD (04:11):

The goals are also always to try to minimize side effect profiles. And we try to do that as best as we can within the confines of what we can do and what’s safe.

Sarah Sammons, MD (04:21):

The right dose is the one that you can stay safely on and consistently. I can’t say that enough. A colleague of mine once said you simply can’t benefit from a drug that you don’t take. We would rather reduce the dose of a drug and keep you on it than have you just completely stop early because your side effects were so bad that you just threw the baby out with the bath water and said I can’t do this anymore.

Sarah Sammons, MD (04:47):

How do we determine the dose? Most drugs are studied for the first time in the metastatic setting. That’s not to say ... that’s changing a little bit. There are some trials that study phase I dosing in the early stage, but it’s much more common in the advanced setting to study new drugs. There’s more patients looking for trials; it’s considered a little bit safer.

Sarah Sammons, MD (05:15):

Generally the way we study a dose is the scientists who study these drugs in animals. So usually mouse models, and then sadly, because I’m obviously an animal lover, we generally put the drugs into larger animal models too, like monkey or dog, just to look at side effects. Based on the PKs, PDs, efficacy that they see in the animal models then they determine what dose would be the right dose to start in human studies.

Sarah Sammons, MD (05:52):

We start at that dose in the phase I. And then you usually treat three to six patients at that dose. You monitor for them for side effects. And if the side effects are not too bad, meaning they don’t have any dose-limiting toxicities, then they go up to the next dose. And they do that until they reach a dose that has too many DLTs, basically too many side effects. So they escalate it until they see side effects. And that’s what gets you to your maximum tolerated dose.

Sarah Sammons, MD (06:23):

And then historically we use the maximum tolerated dose as the dose. But now with newer pathways, we’re trying to get to the dose lower than the maximum tolerated dose, more the dose that’s the most efficacious for patients with the most manageable side effect profile. But that’s really a change that has occurred in the last 5 years or so through the advocacy from groups like LBBC and patient advocates.

Sarah Sammons, MD (06:51):

What’s true is that the optimal dose for your cancer might not be the maximum tolerated dose. More is not always better. New initiatives are really trying to push that.

Sarah Sammons, MD (07:08):

Janice will probably talk to you a little bit about this later, but her and many patient advocates have been involved in this movement called The Right Dose. You can go to therightdose.org. It’s patient-centered dosing initiative where patients had said, “Hey, wait, I don’t want to go to the dose that has the most side effects. I want to go to the dose that is going to work for my cancer, but have less side effects.”

Sarah Sammons, MD (07:37):

They did a survey of 1,200 metastatic breast cancer patients in 2020, and 82% of patients who had dose reductions reported meaningful relief in their symptoms. So dose reductions do work to provide relief of symptoms, and the majority of patients supported flexible dosing discussions.

Sarah Sammons, MD (08:00):

There’s going to be a more antibody-drug conjugate focused survey that’s going to be coming out soon that maybe Janice can talk to us about.

Sarah Sammons, MD (08:11):

Interestingly in this survey, in the 2025 updated survey key findings, 82% of patients experienced a bad side effect to medications. So this is just so common for all breast cancer patients. Seventeen percent started on a lower dose. Their oncologist said, “Hey, I’m worried about how the high dose might perform for you. Let’s start at a lower dose.”

Sarah Sammons, MD (08:37):

Ninety-four percent started at the recommended dosing frequency, meaning you’re supposed to take it every 3 weeks, you took it every 3 weeks.

Sarah Sammons, MD (08:48):

Thirty-five percent reduced the dose after starting at the recommended dose. That’s 1 in 3 patients needed a dose reduction. The reasons for the dose reduction were generally, half of patients had a bad side effect, 35% had concerns about side effects, 5% had other health problems, and 15% reduce the dose for other reasons.

Sarah Sammons, MD (09:10):

Now, because of advocates like you all on the line, and Janice and many others, the FDA has really heard the concerns of everyone. And several years ago, they started an initiative called Project Optimus. And I will say that when you want to tell thousands of pharmaceutical and biotech companies what to do, it really has to start with the regulators because drug companies are going to want to push the dose with the highest chance of getting their drug approved because they spend millions, sometimes billions, of dollars by the time they get into a trial. So it really needs to come from a regulator standpoint. And so I’m glad that the FDA did this.

Sarah Sammons, MD (09:57):

The goal of Project Optimus is to shift from the highest tolerable dose to the optimal dose. And it encourages randomized dose finding. So once you get up to that maximum tolerated dose, they’re now requiring companies to study the lower dose too, so the maximum tolerated and the lower dose for efficacy. That way they can determine maybe the lower dose is just fine, and that’s what can be moved into phase III trials.

Sarah Sammons, MD (10:31):

They also had the goal of focusing on long-term tolerability. A lot of times the safety of drugs is just studied in the first month. And as you all know, side effects can happen at any time, years later. And they’re requiring multiple dose studies.

Sarah Sammons, MD (10:48):

So for new drugs moving forward, there’s going to be clearer dose guidance, hopefully leading to better quality of life without losing effectiveness for patients.

Sarah Sammons, MD (10:59):

And I just wanted to give an example of success. Camizestrant is an oral SERD, that is an oral, basically, form of fulvestrant, that’s being studied in the metastatic setting. This was their phase II trial where, based on Project Optimus, they looked at 75 milligrams of camizestrant and 150 milligrams of camizestrant, 75 is in the light blue, 150 is in the dark blue. You can see there was no difference in efficacy for twice the dose. And based on this, they move 75 milligrams into the phase III study.

Sarah Sammons, MD (11:39):

This is just an example of hope, I hope for everyone on the line, that moving forward, more elegant dosing studies would’ve been done. You know, 10, 5 years ago, they only would’ve studied 150. We never would’ve known that 75 was good enough and had a better side effect profile and could move that into phase III trials for approval.

Sarah Sammons, MD (12:02):

So let’s talk a little bit about dose reductions in early-stage breast cancer.

Sarah Sammons, MD (12:08):

Dose reductions are obviously when you come into the doctor and you say, “Hey, I’m having a lot of these side effects.” And your doctor might say, “OK, that’s pretty significant. Maybe we should reduce the dose.”

Sarah Sammons, MD (12:23):

Now I will say that dose reductions in early-stage breast cancer and metastatic breast cancer are a little bit different. Dose reductions are a little less common in early-stage breast cancer. And it also depends on what we’re talking about, whether we’re talking about oral therapies or chemotherapies.

Sarah Sammons, MD (12:48):

In early-stage breast cancer, the treatment duration is shorter. Oftentimes chemotherapy is 4 to 5 months, whereas in metastatic breast cancer, treatment can be a lot longer than that, and side effects are generally more challenging. In the early-stage setting, doctors also might feel the need to treat the patient very aggressively despite side effects because they’re shooting for cure.

Sarah Sammons, MD (13:11):

And regimens are based off of metastatic breast cancer dosing. It’s pretty rare for companies to change the dose in the early-stage setting, though, I will say that they did just do that with ribociclib, or Kisqali. The metastatic dose is 600 milligrams and the early-stage dose is 400 milligrams. So we are seeing some evolution there as well.

Sarah Sammons, MD (13:37):

There’s not as much data in early-stage breast cancer to support dose reductions, but we will talk about a little bit of data.

Sarah Sammons, MD (13:46):

Some reasons for a dose reduction. Let’s first talk about chemotherapy. Probably the most common chemotherapy that we give in early-stage breast cancer is dose-dense adriamycin with a taxane. So paclitaxel, nab-paclitaxel, or docetaxel. Taxanes have very significant neuropathy risk, and dose reductions can be very, very helpful in reducing the neuropathy but also making sure that the neuropathy is not a lifelong problem. Sometimes we run into issues with nausea and diarrhea. Usually that can be controlled with supportive medications. If we can give supportive medications like anti-nausea treatments or antidiarrheal treatments and that helps without us having to reduce the dose, we prefer that. But if we’re optimizing all of the anti-nausea medicines or antidiarrheal medicines that we can give you and you’re still struggling, then that would be a potential indication for a dose reduction.

Sarah Sammons, MD (14:51):

Certainly if a patient is having interference with their activities of daily living. I’ve had patients come in after a dose of chemotherapy and say, “Dr. Sammons, I was not up off the couch for more than an hour a day.” That’s not OK. So really talking to your doctor about, if your chemotherapy is rendering you on the couch 90% of the time, unable to cook, unable to clean, unable to do the daily things that you need to be doing, that’s something that you need to tell your team about. Because it could be an indication for a dose reduction, but also making sure that there’s nothing else going on.

Sarah Sammons, MD (15:27):

Certainly in the setting of dangerous medical situations like neutropenia, that’s when your white blood cell count is very low and you’re at risk for infection, severe anemia, severe thrombocytopenia could be indications to reduce the dose. And then there’s other serious medical conditions like interstitial lung disease that can happen as well.

Sarah Sammons, MD (15:52):

We know that dose reductions lead to better tolerance. There’s really not a question about that, but how do dose reductions impact outcomes in early-stage breast cancer?

Sarah Sammons, MD (16:04):

I’m going to start with chemotherapy in early-stage breast cancer. There was this pretty big study of 1,300 women that was done by the Canadians a couple of years ago. They looked at patients with stage I through III hormone receptor-positive, HER2-negative breast cancer, who basically got adriamycin-taxane-Cytoxan-based regimen. And they saw that if patients needed a dose reduction and they got less than 85% of the intended dose in the first six cycles, that outcomes were slightly less. Patients were a little bit more likely to recur in the early-stage setting if they needed a dose reduction in cycles one through six.

Sarah Sammons, MD (16:49):

Now, that’s not to say that if you’re having severe side effects, that your doctors should not dose reduce. Sometimes we have to dose reduce to get you through the treatment, but this is one of the reasons why doctors in the early-stage setting really try to maximize in terms of chemotherapy, your supportive medications, and try to keep you at the same dose before dose reducing. However, if you’re having severe side effects that is very important. And if dose reduction is needed, then we absolutely still do it.

Sarah Sammons, MD (17:24):

Now, alternatively, for patients with high-risk hormone receptor-positive, HER2-negative breast cancer, we now have approval of abemaciclib, or Verzenio, added to endocrine therapy in the first 2 years. This is really for lymph node-positive patients, four or more nodes, T3 tumors, grade 3 tumors that are node positive. So a higher risk population. Abemaciclib does reduce the risk of recurrence by about 8%, and it does improve overall survival.

Sarah Sammons, MD (17:56):

In the monarchE study which looked at this, they did look at the impact of dose reductions on recurrence risk. And what they saw was that 50% of patients, 1 in 2 needed a dose reduction of Verzenio. I don’t know if anybody on the lines had Verzenio, but the main side effect is diarrhea and it cannot be pretty sometimes. So half the patients needed a dose reduction.

Sarah Sammons, MD (18:22):

But the amazing news was if you needed a dose reduction, even a substantial dose reduction, there was no difference in outcomes. And so this data has made me feel very, very comfortable that for my patients on Verzenio or really any of the other CDK 4/6 inhibitors in the early- or late-stage setting. Dose reduction really does not impact outcomes, and I think that that is very good news for our patients.

Sarah Sammons, MD (18:50):

So if you’re in the crowd on Verzenio and your doctor has been telling you, “You know what, a dose reduction would really help your side effects like diarrhea and nausea, loss of appetite,” just know that we have very good data that it would not impact your outcome, which I think is good news.

Sarah Sammons, MD (19:08):

A colleague of mine, Erica Mayer at ASCO this year, presented a study in early-stage, high-risk hormone receptor positive breast cancer, where they dose escalated the dose of abemaciclib. They started all the patients on 50 milligrams twice a day. If they were doing well for 2 weeks, then they upped it to a hundred milligrams twice a day. If they were doing well on that, then they increased it to the full dose, which was 150 milligrams twice a day.

Sarah Sammons, MD (19:37):

What they found was that we were able to keep more patients on the medication doing it this way. We were able to dose escalate most patients, and patients reported less side effects this way than if they started at the full whopping dose of 150 milligrams. So this is a really nice strategy.

Sarah Sammons, MD (19:59):

I will say in early-stage breast cancer, it’s very hard to just prescribe 50 milligrams for 2 weeks and then a hundred milligrams for 2 weeks, and then 150. That’s a lot. And your insurance gets confused. I start most patients in the early-stage setting on a hundred milligrams twice a day of abemaciclib. Now that is not guideline driven, so don’t go to your doctor and say, “This is what Dr. Sammons said. This is in the guidelines.” That is just what I do because I know that the outcomes are the same and that it’s better tolerated.

Sarah Sammons, MD (20:30):

The bottom line is, if you’re having a lot of side effects, you have to talk to your medical team. Just because dose reductions are less common in early-stage breast cancer doesn’t mean that they can’t or shouldn’t happen. Certainly if it’s CDK 4/6 inhibitors, very comfortable with the dose reduction. Chemotherapy, if you need a dose reduction, you need a dose reduction. We do try to maximize supportive care before dose reducing. But if you need one, you need one. And we’d rather you actually finish the chemotherapy with a dose reduction than not finish it at all or end up in the hospital. Dose reductions are OK, and your care team will know the potential risks and benefits for you so that you can land on a right dose.

Sarah Sammons, MD (21:19):

I did see earlier in the chat, I’m not looking at the chat until the end, but I saw a lot of patients saying, ”I have a lot of side effects from my endocrine therapy. Maybe my aromatase inhibitor.” Maybe your letrozole, your anastrozole, your exmestane. Sadly there’s one dose of all of those drugs. and we really don’t have data with less.

Sarah Sammons, MD (21:40):

There is some data for tamoxifen lower doses, and there’s actually an ongoing phase III trial for early-stage patients with hormone receptor-positive, HER2-negative stage I breast cancer, looking at 5 milligrams of tamoxifen versus 20 milligrams of tamoxifen. So we will have some data there soon.

Sarah Sammons, MD (22:02):

We have data in the pre-breast cancer space that 5 milligrams is probably enough. But we sadly do not have any aromatase inhibitor lower dose trials.

Sarah Sammons, MD (22:15):

How about outcomes in metastatic breast cancer?

Sarah Sammons, MD (22:19):

When we’re thinking about outcomes in metastatic breast cancer, we’re thinking more about progression-free survival, the time until the cancer grows, and how long people live. And we have very good data, and I’m going to move a little quicker because I think I’m on the slower end, that dose reductions for CDK 4/6 inhibitors, including palbociclib, ribociclib, and abemaciclib, do not impact progression-free survival or overall survival. And so if a patient is having side effects, I feel very comfortable reducing the doses of those.

Sarah Sammons, MD (22:54):

Recently, last week, this study came out, it was the AMELEE study that looked at starting patients on ribociclib 400 versus 600. Interestingly, and this was about 360 patients or so, the progression-free survival, meaning the amount of time until cancer grew, was the exact same with 400 versus 600. So was the overall survival. I will say the response rate, meaning how much of the breast cancer shrunk was very slightly less, 5% less with 400 milligrams compared to 600.

Sarah Sammons, MD (23:33):

Based on this study, I mean, I still start my young and very healthy, robust patients at 600 and then reduce based on that. But my older patients, I generally start at 400, and I think we have very good data to support that.

Sarah Sammons, MD (23:47):

We also have a capecitabine study that looked at 1,500 milligrams twice a day, 1 week on then 1 week off, versus standard dose, which is higher than that, 2 weeks on and 2 weeks off. And we saw very similar outcomes as well. And the side effect profile with the lower dose of capecitabine was much better, less diarrhea, less hand foot, meaning rash on the hands and feet.

Sarah Sammons, MD (24:14):

I will say, and we should really petition the companies to do this, I have not seen any dose reduction efficacy data with Enhertu and the other ADCs. I would really like to see that because I think ADCs are very hard to tolerate, and we’d love to have data showing that dose reduction still leads to the same outcomes.

Sarah Sammons, MD (24:35):

To conclude: Oncology drug development previously relied on the maximum tolerated dose, which was not a patient-friendly way to study drugs. And Project Optimus by the FDA has required companies to study lower doses below the MTD, which is good. Dose reductions do not impact outcomes for CDK 4/6 inhibitors, palbociclib, abemaciclib, ribociclib, and so feel very comfortable dose reducing there. And same with abemaciclib in the early-stage setting. We really need to encourage pharmaceutical companies to show us dose reduction in efficacy data for all of the drugs because quality of life and side effects matter. And there’s ways to help manage quality of life and side effects outside of dose reductions, which we really didn’t talk about today. But dose reductions are a very, very effective way to manage side effects. And one size fitting all dosing is hard to justify and just not right for everyone.

Caroline Koffke, RN, BSN, OCN (25:37):

Thank you so much, Dr. Sammons. That was such a nice and concise presentation on such a wildly massive topic that is so, so important. So I really appreciate it, and I know we have so many questions for you. There’s lots of things in our Q&A, and I know we will try to get to as many as possible.

Caroline Koffke, RN, BSN, OCN (25:56):

Before we do that though, I would love to bring our patient advocate, Janice, back on. Janice, if you don’t mind introducing yourself, telling us a little bit more about your work. Obviously Dr. Sammons started to explain Project Optimus and PCDI, but we would love to hear it from you. And then we can hit some of these questions.

Janice Cowden (26:17):

Great, thank you, Caroline, and thanks so much for inviting me to be here today.

Janice Cowden (26:20):

I have been living with metastatic triple-negative breast cancer, as you mentioned earlier, since 2016. Very fortunate to have no evidence of disease for almost 9 years.

Janice Cowden (26:33):

PCDI is a patient-founded, patient-led organization. We are a nonprofit. And basically the reason it was founded by Anne Loeser, who was an incredibly brilliant patient advocate, back in 2019, is she saw the toxicities and all of the fallout that was happening from these high doses and these toxicities that are side effects from treatments for people with metastatic breast cancer. She founded PCDI in 2019, and basically our mission and vision is we advocate for a more balanced approach to cancer treatment where both the effectiveness of the therapy and the patient’s quality of life are considered.

Janice Cowden (27:22):

And part of that is looking at early-phase clinical trials, as Dr. Sammons already talked about, where the historically they are designed to find the maximum tolerated dose. And as she also pointed out, one size does not fit all. There may be multiple reasons why patients have difficulty tolerating oncology drugs. Those could be due to comorbidities, it may be the way they metabolize the drugs. There are just so many reasons why one size fits all does not work.

Janice Cowden (27:57):

So when Anne founded PCDI, the Patient-Centered Dosing Initiative in 2019, her first mode of action was to do a patient survey, which Dr. Sammons also talked about a little bit earlier. We had 1,221 metastatic breast cancer patients who responded to that.

Janice Cowden (28:17):

And what we found is when we followed that up with an oncologist survey the following year in 2021, was that the perception between how many patients were having really significant or bad side effects was different.

Janice Cowden (28:36):

The oncologist looked at what they believed were patients, the incidence of having severe side effects. And while 66% of the patients said that their treatment side effects, they had reported them to their oncologist, 83% of those patients felt better with a dose reduction.

Janice Cowden (29:03):

So 87% of oncologists indicated that they started patients at a lower dose for various reasons. And they also were very willing to have these discussions about getting creative with dosing. Dose reductions can be like Dr. Sammons said, the schedule, the dose that you’re taking, and there are a lot of ways to look at that.

Janice Cowden (29:28):

One of the most important things I think that, that Anne always spoke about was the importance that patients, especially those who are on an oral medication, do not change their dose or their frequency or their schedule without first having that conversation with their oncologist. That is incredibly important. For those who are on IV therapy, it’s a little bit different. We don’t have as much control over that. But for those with oral medications, always speak to your oncologist.

Janice Cowden (29:57):

What we’ve continued to do, unfortunately, Ann passed away from metastatic breast cancer and GI complications in October of 2023. So it’s been just 2 years ago, and we are continuing her legacy. PCDI is made up of members who are all living with metastatic breast cancer. As Dr. Sammons reported earlier in one of her slides, we did an antibody-drug conjugate, which is the ADC, study for those who are living with metastatic breast cancer earlier this year. And those were reported out. We had a poster at the MASCC Annual Meeting in June.

Janice Cowden (30:38):

And then we also opened a dosing study for those living with metastatic breast cancer regardless of what treatment you’re on, and that one is reopened now. We did close it to get some data analysis, and it is reopened. So if you have not taken our metastatic breast cancer patient dosing survey, please email surveys@therightdose.org to request to get a link for that survey.

Janice Cowden (31:09):

We have already submitted an abstract for the San Antonio Breast Cancer Symposium in December of 2025, and we will have a poster there. So we will be presenting that.

Janice Cowden (31:19):

But basically, PCDI’s mission is just to look at the individuals, look at dose optimization for individuals, because we know that patients who are living with metastatic breast cancer are basically going to be on treatment for life. And those toxicities add up over time. And the toxicities vary from one person to another, the side effects, how they’re dealt with.

Janice Cowden (31:45):

One thing that’s very important that Dr. Sammons has also said is always report your side effects to your oncologist. They can’t help you if you don’t tell them how you’re feeling and what’s going on. No matter how minimal you think they might be, there may be a way to minimize those, those side effects. You might be able to get palliative care on board, and they can help you manage the symptoms of disease and the side effects from treatment.

Janice Cowden (32:12):

And one of the things that we really are so proud of at PCDI is Anne presented our patient survey at the ASCO Annual Meeting in 2021, and it was soon after that that FDA created Project Optimus, which looks at new drugs in a range of doses, because we should have a range of doses that are available, as well as Project Renewal, which looks at drugs that are already FDA approved. And hopefully we’re going back, like some of these studies that Dr. Sammons talked about today, these drugs are already approved. So we can go back and look at them and look at the data and compare that efficacy at different doses as well as the side effect profiles.

Janice Cowden (33:02):

We really want to encourage industry to do that, trial investigators, to really look at the efficacy and a range of doses in early-phase clinical trial studies. One of the things we’re most proud of is soon after Anne presented at ASCO 21, at the annual Friends of Cancer Research meeting, Dr. Atik Rahman actually made a statement and said it’s loud and clear from our patients that the drugs are too toxic.

Janice Cowden (33:32):

So as we work towards personalized medicine in oncology, it is vitally important that we find drugs that we can stay on for longer periods of time. Drugs that are effective and that we can stay on because the toxicities are reduced. It’s really a win-win situation. It’s a win for the patients who need those drugs to treat their cancer. It’s also a win for the pharmaceutical manufacturers because patients will stay on their drugs longer.

Janice Cowden (34:03):

We also have some dose reduction studies that are on our website at therightdose.org. So please feel free to check that out.

Janice Cowden (34:13):

If you don’t really know how to start that conversation with your oncologist, about side effects, about what your options might be for dose reductions, we also have a flyer available. It is a two-sided flyer. We do bring these postcards, we had them at the LBBC annual metastatic breast cancer conference and we’ll have them again at San Antonio. It gives you some tips on how to start that conversation. One side is specifically for patients, the other side is specifically for the healthcare provider, for your oncologist, or speak with your nurse practitioner, your infusion room nurse, anybody that is managing your cancer care, please speak to them about any toxicities that you might be having with relation to your treatment.

Caroline Koffke, RN, BSN, OCN (35:02):

Thank you so much, Janice. I think it’s so important to hear about the work that you’re doing, and it’s so hopeful to hear that the work that PCDI, or Patient-Centered Dosing Initiative, has done has led to these wide scale changes. And as Dr. Sammons mentioned, we’re now seeing trials that are really like the camizestrant trial that AstraZeneca put on, where they really are taking a look at these other doses besides just trying to hit it really high and really hard.

Caroline Koffke, RN, BSN, OCN (35:33):

I did want to mention, because there was a lot of questions that kind of referred to this. Can I go on a lower dose? Can I do this? Can I do that? We only have the data that we have based on the clinical trials that have been run, which is how we get these NCCN guidelines and how we make treatment decisions. So Janice, to your point, that’s what we’re trying to look at now with our new trials and also being reflective about how older trials were structured. But for a lot of these things we don’t have cold, hard concrete data. So just wanted to mention that.

Caroline Koffke, RN, BSN, OCN (36:10):

But Janice, a quick question for you, and thank you, Dr. Sammons, for hopping back on because we have lots of questions to discuss.

Caroline Koffke, RN, BSN, OCN (36:15):

This is a tough one. You might not have an answer. But with the changes in the FDA and HHS, are we concerned about the future of Project Optimus?

Sarah Sammons, MD (36:26):

I think I can say that I have not heard that Project Optimus is going anywhere. Of course with change in administration and the major changes that are going on in this administration, I think there’s always a fear that there could be a shakeup. I have not heard of any changes, and I will say that even this FDA does seem to be concerned about side effect profiles and safety. And so I’m hopeful that it will continue. But of course, I don’t know.

Caroline Koffke, RN, BSN, OCN (37:02):

Yeah, it’s tricky.

Caroline Koffke, RN, BSN, OCN (37:03):

Janice, any any thoughts on that? Anything you’ve heard on your end?

Janice Cowden (37:07):

I have not heard anything on my end. I think, like Dr. Sammons said, we don’t know what we don’t know, and only time will tell.

Janice Cowden (37:13):

I do hope that it does not impact Project Optimus in a negative way because we really need a more patient-centric approach to oncology care at this point.

Janice Cowden (37:27):

And I also wanted to make just a very brief point too. Where even though PCDI has been focused mainly on metastatic breast cancer, now that we’re looking at trials that are bringing some of these antibody-drug conjugates like Trodelvy and Enhertu potentially into the early-stage setting, even though they’re on these treatments for a finite amount of time, I think this is definitely something that is relevant for all cancer patients, all different types of cancer as well as all different stages.

Caroline Koffke, RN, BSN, OCN (38:02):

Thank you so much.

Caroline Koffke, RN, BSN, OCN (38:03):

So for both of you. Janice, I know you’re triple-negative, so you wouldn’t have been on an aromatase inhibitor, but as I’m sure you can both imagine, we have lots and lots of questions about aromatase inhibitors from our early-stage or metastatic individuals who have to be on these for a long, long time with some really debilitating side effects.

Caroline Koffke, RN, BSN, OCN (38:24):

Dr. Sammons, I know you touched on this, can you just maybe resummarize the research that’s going into this. A lot of people are asking: Can I take a week off every now and then? Can I switch up my dose a little bit in order to stay on the medication longer? How do you help coach patients on an AI?

Sarah Sammons, MD (38:48):

Yeah, absolutely. So first of all, I will say that about 40% of patients don’t make all 5 years on an AI because side effects are so severe. So I think even just validation and knowing that you’re not alone is really important.

Sarah Sammons, MD (39:07):

One thing I do when my patients are struggling, we have three different aromatase inhibitors. We have letrozole and razzo and exemestane. Letrozole and anastrozole are the original nonsteroidal aromatase inhibitors, and exemestane is steroidal. Doesn’t mean it’s a steroid, it’s just the differences in the structure of the compound.

Sarah Sammons, MD (39:29):

For whatever reason about 30% of the time when you switch a patient from one AI to another their side effects improve. So if that’s not a strategy that you’ve taken, it is something that I would consider. All of the aromatase inhibitors have similar efficacy. One is not better than the other, and for whatever reason, some people just tend to tolerate one aromatase inhibitor better than the other.

Sarah Sammons, MD (40:00):

And so I would talk to your doctor about switching if you have not, because the reality is there is only one dose of all of the aromatase inhibitors. So you can’t really dose reduce an aromatase inhibitor.

Sarah Sammons, MD (40:16):

If I have a lower risk patient and they’re miserable on the aromatase inhibitors and they’re postmenopausal or even premenopausal and switching to tamoxifen is also reasonable. We have different side effect profiles of each that you can discuss with your doctor. But tamoxifen definitely has less joint pain. There are some other small risks with tamoxifen, but switching to tamoxifen is possible too.

Sarah Sammons, MD (40:50):

And then I would just also say that there’s a lot of future hope. So there are phase III trials going on, looking at lower doses of tamoxifen. There’s also phase III trials going on looking at oral selective estrogen down regulators. So oral forms of tamoxifen, which have much less joint pain. I’m a little worried that they’re not going to be better than the aromatase inhibitors in preventing recurrence, but I do think that they will be better tolerated and they’re in phase III trials right now. Even one is fully enrolled and we should see data in the next few years.

Sarah Sammons, MD (41:31):

And so I think we will have other endocrine therapies other than AIs and tamoxifen in the next 5, certainly 10, years. But it is a challenge.

Caroline Koffke, RN, BSN, OCN (41:42):

Thank you for explaining that. I know this is a constant struggle. And someone said it so nicely. It’s hard sometimes when doctors are just saying, “Yep, take this for 5 years, this is what you need.” And not really understanding what that 5 years might feel like for someone.

Caroline Koffke, RN, BSN, OCN (42:02):

So I think exactly as you said, advocating for yourself, potentially talking about a switch in medication, if that’s indicated for you. But also just sometimes it’s helpful to just know that doctors and researchers are thinking about this and trying to make it better, even if it’s not in the immediate moment. So that’s really helpful.

Sarah Sammons, MD (42:24):

There’s also a lot of ways that patients can support themselves on aromatase inhibitors. Acupuncture, exercise, tart cherry juice are all things that have been shown to improve joint pain, hot flashes. So there’s a lot of supports too. But even with that, it’s hard.

Caroline Koffke, RN, BSN, OCN (42:45):

Absolutely. Those are great recommendations though. And I know, as you said, being on the drug and even if it does have to be modified in some capacity is better than not being on it at all.

Caroline Koffke, RN, BSN, OCN (42:55):

Question from someone. So this is, and maybe both of you have some thoughts on this. Is it better to reduce the dose or change the cadence? And I know that those things are kind of the same cadence is dosing, but would you accept, so their example is, 3 weeks on, 1 week off versus 3 weeks on, 2 weeks off, or getting an actual dose reduction and staying on the typical cadence. Any thoughts there?

Sarah Sammons, MD (43:28):

I generally recommend taking the drug in the way it was studied, just because if a patient does not have the outcome that we hoped for taking the drug and they weren’t taking it in the right dosing, I don’t know if that’s because they weren’t taking it in the right cadence or if it’s because their disease truly became resistant to it. And so I prefer to stay at the same cadence. That means if it’s studied 3 weeks on, 1 week off, I would stay there and I would reduce the dose. Because we do have data with reducing the dose, right? But we don’t have data with changing the cadence. And so I would rather reduce the dose than change the cadence.

Caroline Koffke, RN, BSN, OCN (44:14):

Super helpful. Thank you. I think that’s great guidance.

Caroline Koffke, RN, BSN, OCN (44:16):

A couple other comments talking about taking age into account. Our older population sometimes has more adverse effects from these really tough medications. Is there research into age starting at a lower dose? What are your thoughts?

Sarah Sammons, MD (44:35):

Yeah, great question. You are absolutely right, and I’ll actually say that older patients are very underrepresented in clinical trials. So that’s number one.

Sarah Sammons, MD (44:48):

The clinical trials that do study age related to side effects, let’s just talk about the CDK 4/6 inhibitors. They do show that patients that are older have more side effects. There is actually the first trial that ASCO is running is a trial for breast cancer patients that are older than 65, looking at starting them on a lower dose of a CDK 4/6 inhibitor versus full dose. There’s also an ongoing national trial in early-stage breast cancer looking at starting taxotere and Cytoxan at lower doses for women older than 65 versus standard. And so there, there is some ongoing work. But there definitely should be more.

Caroline Koffke, RN, BSN, OCN (45:40):

That’s a tough one. Janice, anything that PCDI has done with regards to age?

Janice Cowden (45:47):

The only thing, I am, as you mentioned earlier, the patient advocate lead on the ASCO CDK 4/6 dosing study for people 65 and older. And I think that will be ... it’s a pragmatic trial. It is not a prospective trial, meaning there’s not any new drugs that are being studied, they’re existing drugs. And we’ve got the two arms where some patients will be randomized to start at the recommended starting dose, whereas other ones will start at the lower dose. And they’ll do what’s called titrate up, meaning they’ll increase the dose as needed or if tolerated.

Janice Cowden (46:22):

I think that will be a really interesting study to see. They are still in the process of accruing for that. So I think that will be some good data.

Janice Cowden (46:33):

I don’t know of any other specific studies other than that one that are going on right now, but I do see that, even with younger people sometimes. Sometimes the lower dose will work just as well, and they’ll have fewer side effects. I think that’s really a very individualized thing. But I think in particular with older adults, like Dr. Sammons mentioned, we are very much, and I’m in that category, we’re very much underrepresented in clinical trials, usually excluded.

Caroline Koffke, RN, BSN, OCN (47:06):

Yeah. That is really tough.

Caroline Koffke, RN, BSN, OCN (47:09):

Well, I’m glad that there is some work being done on this because I think it is super important. And I know, depending on your oncologist, that can be a discussion when you start your next line of treatment. Is the full dose going to be right for me? If you have comorbidities or other things going on in your body. I know we would sometimes make the decision like, “Hey, we’re actually not going to start you on the full dose.”

Caroline Koffke, RN, BSN, OCN (47:31):

So I think having that open and honest conversation, even if we don’t have clear-cut data, is really important.

Caroline Koffke, RN, BSN, OCN (47:38):

Another really great question. For individuals living long term, which we see and it’s incredible with MBC. Janice is an amazing example of that. Are there studies out there about what the long-term effects are of being on some of these toxic medications?

Caroline Koffke, RN, BSN, OCN (47:57):

This person in particular gives the example of Herceptin, Perjeta, and an AI, and they’ve been on it for 6 1/2 years. So are there kind of long longevity surveys of these medications? And if not, how can they get that to happen?

Sarah Sammons, MD (48:16):

Yeah, that’s a really good question. I think there’s definitely data out there, particularly on Herceptin and Perjeta, just single institutional or multi-institutional retrospective studies looking at safety. We do not have that for every drug. And it would be great for patients and physicians to advocate for not only reporting the side effects when things first come out, but doing a 3-year, 5-year side effect update.

Sarah Sammons, MD (48:46):

The reality is on clinical trials, they don’t collect side effects for that long. And so this would have to be real-world analysis. But that is something that we should be doing.

Sarah Sammons, MD (48:59):

I will just say specifically to that patient. We have a study ongoing for patients who have been NED on Herceptin and Perjeta with metastatic breast cancer for over 3 years that’s looking at stopping and what of some of those patients might actually be cured. And that will be presented probably this year at ASCO.

Caroline Koffke, RN, BSN, OCN (49:23):

That is awesome. And actually answers what someone else had asked about how long do I need to be on these drugs. So that’s very, very helpful.

Sarah Sammons, MD (49:34):

And then I also just say for all of the advocates and foundations out there, these are the types of studies we need to fund. Industry is not going to fund a study stopping a drug. So these are where NCI funding comes in, patient advocacy, foundation funding comes in.

Caroline Koffke, RN, BSN, OCN (49:53):

I think that’s so important. It’s a great call to action because you’re right, pharma, that’s not what they’re looking to do.

Sarah Sammons, MD (50:00):

They’re great, pharma’s great, and we need them, but they have bottom lines.

Caroline Koffke, RN, BSN, OCN (50:04):

Absolutely. We have a couple individuals and we’ve mentioned these ADCs, or antibody-drug conjugates. For those who may be less familiar, those are more targeted chemotherapies. We always describe them as a heat-seeking missile. Drugs like Enhertu, drugs like Trodelvy, drugs like Datroway, which have been approved in the metastatic setting, they’re creeping into early stage as well. They can be really hard to tolerate. And Janice, you mentioned this, Dr. Sammons, you mentioned this, having some brutal side effects with Enhertu, which I had seen in my practice many, many times. What are those dose reductions like? I know we don’t have data on them, but what’s that feasibility? And then one person actually mentions being overweight as well. So maybe you could talk a little bit about ideal body weight dosing if we use that in Enhertu. How about it?

Sarah Sammons, MD (51:01):

Yeah, so we generally don’t use ideal body weight dosing. We use BSA and milligrams per meter squared dosing.

Sarah Sammons, MD (51:10):

Many patients on Enhertu need a dose reduction. I will also say, and I don’t know, please comment in the crowd if you feel the same way, but a lot of my patients feel like the first two to three doses of Enhertu hit them hard and then they kind of get used to it. So I try not to do a super early dose reduction unless the patient is really, really doing terribly just because I do find that things kept better.

Sarah Sammons, MD (51:41):

Sometimes they don’t get better. And dose reductions can be very helpful for fatigue. They can be very helpful for, there’s a lot of nausea to this regimen and you want to make sure that your team is giving you three drugs with the infusion. And then I generally give my patients a few days of steroids after the infusion, which helps really well. Some patients have side effects to the steroids too, and then you have to take them off or reduce them. So you just gotta have a team that’s willing to work with you because it’s so patient dependent.

Sarah Sammons, MD (52:17):

But reducing the dose is often needed. We don’t have data on the impact of efficacy with ADCs, but if you need to reduce the dose, I’d rather you reduce it. I’d rather reduce it and keep you on it than just have you go to something different.

Caroline Koffke, RN, BSN, OCN (52:40):

That’s really, really helpful. Thank you for explaining that.

Caroline Koffke, RN, BSN, OCN (52:44):

Another person was asking about med holidays. I know I’ve talked with oncologists about this a lot. Would you consider a med holiday a dose reduction?

Sarah Sammons, MD (52:56):

Would I consider a med holiday a dose reduction? I would not consider a med holiday a dose reduction per se. I would consider it a holiday <laugh>.

Caroline Koffke, RN, BSN, OCN (53:08):

I think that’s a very fair answer. And again, we don’t have data on that kind of stuff unfortunately. But it can be really beneficial.

Sarah Sammons, MD (53:16):

Yeah, I just see someone ... Enhertu is weight-based. It’s just based on milligrams per meter squared and not ideal body surface area. Which was the question.

Caroline Koffke, RN, BSN, OCN (53:25):

Yes. Thank you for that.

Caroline Koffke, RN, BSN, OCN (53:27):

Where are we, and this is broad and you, you have mentioned this somewhat. But where are we in kind of going more towards that personalized medicine, that individualized dosing, and sorting out what might work best for someone, especially if you’re hypersensitive to some of these medications, as opposed to just going through kind of this more standard blanket dosing.

Sarah Sammons, MD (53:58):

Potentially not so close. Just because ... I mean, with chemotherapy it is generally weight-based. It’s the oral drugs that are not so weight-based. The only oral drug that’s weight-based is capecitabine. But for CDK 4/6 inhibitors, for PIK3CA inhibitors that’s where it’s really not weight based. It’s just starting at a flat dose. And so that’s where we probably with the oral drugs is probably where we should get a little bit more elegant in terms of our dosing strategies.

Sarah Sammons, MD (54:35):

I think that it would be a lot more challenging and it would probably stifle the ability to quickly do a clinical trial and get a drug to market if we were doing more elegant weight-based strategies. But it’s still something that we should continue to troubleshoot and advocate for and we can do that.

Caroline Koffke, RN, BSN, OCN (55:05):

That’s great and really helpful.

Caroline Koffke, RN, BSN, OCN (55:06):

Janice, anything, I know obviously Dr. Sammons, you’ve done such a beautiful job of answering these questions. Janice, any other suggestions or feedback for people either early stage or metastatic who may really be struggling and how would you advise?

Janice Cowden (55:24):

Well, I think it’s already been said, please have that conversation with your your entire oncology team, whomever you’re seeing, whether it’s a nurse practitioner, a PA, your infusion room nurse, your oncologist, all of them. Keep a journal, at least that worked for me. Keep a journal of what side effects you’re having because when you get into your appointment, the chances of you remembering 2 weeks ago that you felt really bad, or you had these symptoms, so keep a journal.

Janice Cowden (55:58):

There are a lot of platforms out there too where you can actually input side effects online into a platform, and then you could just print it out or pull it up when you’re in the office. So always have those conversations with your oncology providers.

Janice Cowden (56:14):

I think, too, especially in the metastatic setting, because about 80% of us in the U.S. are seen in community oncology settings, if for some reason, something doesn’t feel right or even if it does and you have a generalist as your oncologist, consider getting a second opinion. Or you could be like me and get four of them. There’s never too many.

Janice Cowden (56:40):

I just think that ... because I think the quality of care that we receive really impacts our life especially in the metastatic setting. But even in early stage, I also got second opinions from every single provider. I think that is, if you can do it, I think that is a very important thing to do, especially in the metastatic setting, you know, to at least just have someone on your team. If you have progression of disease, if you’re changing treatments, maybe you’re not sure about whether the treatment plan is the right one or the best one for you. You have somebody you can fall back on who is an expert, like Dr. Sammons, in breast cancer. It’s the difference between seeing patients with all different types of cancers versus having that focus on breast cancer alone. So that’s probably my highest recommendation.

Caroline Koffke, RN, BSN, OCN (57:36):

That is such a good recommendation. And you’re right, being able to find those second opinions with someone who just treats breast cancer and can really keep their their nose to the grindstone of the research is so important.

Caroline Koffke, RN, BSN, OCN (57:48):

Write things down. I always say, take a friend or a partner with you. So many times patients would come in, and their friend would be like, “What are you talking about, you’re fine? You haven’t gotten out of bed!” And that’s what we need to hear as a care team. So I think all of those are great suggestions.

Caroline Koffke, RN, BSN, OCN (58:04):

Dr. Sammons, any other final notes from you for this amazing crew who’s here today?

Sarah Sammons, MD (58:12):

No. A very engaged crew!

Sarah Sammons, MD (58:14):

Talk to your teams, particularly with oral medications. Oftentimes dose reductions don’t impact outcomes, but they can make your quality of life immensely better. And so don’t suffer in silence. Talk to your team. And keep advocating because I think Project Optimus is a result of hearing the patient voice. And so keep doing your thing, advocating out there. And until next time.

Caroline Koffke, RN, BSN, OCN (58:44):

Amazing. Well, thank you so much, Dr. Sammons and Janice, for sharing your expertise. I know we all benefited greatly. I learned a ton myself from the information that you both shared.

Session 3 | Managing menopause: What are my options?

Laila Agrawal, MD (00:00:09):

It’s my honor to be here and to talk to you today about managing some of the side effects that come along with cancer treatment. Thank you for that introduction.

Laila Agrawal, MD (00:00:18):

As you mentioned, I’m a medical oncologist, I treat breast cancer. So we’re going to talk about a lot of the practical things that we encounter and go through a range of different options of how we can address this.

Laila Agrawal, MD (00:00:32):

To start off with, I’m just going to talk about what is menopause. We hear this word out there a lot, but what does it actually mean?

Laila Agrawal, MD (00:00:40):

One of the definitions is that menopause is defined as the period that happens 12 months after the last menstrual period. And then that is sometimes termed “menopause.” It’s associated with a myriad of different physical and mental changes.

Laila Agrawal, MD (00:01:00):

The term postmenopause or postmenopausal is basically the rest of a person’s life after this menopause time point.

Laila Agrawal, MD (00:01:11):

And then perimenopause, another term we hear a lot, is considered the transitional period prior to menopause, where hormone levels can fluctuate significantly. People may experience physical and emotional changes. And on average, this can typically start in someone’s forties, but that can be a very wide range and it can last for months or even years.

Laila Agrawal, MD (00:01:35):

So these are some of the standard definitions that are out there about these terms. But let’s hold on. Not so fast, because this doesn’t really account for what everybody is experiencing and going through. Because periods can stop, but that doesn’t always mean menopause.

Laila Agrawal, MD (00:01:53):

So what am I talking about? If somebody had, for example, a hysterectomy, their uterus was removed, but their ovaries were left in place, well, they’re not going to have menstrual cycles anymore. However, their ovaries are still going to be producing hormones.

Laila Agrawal, MD (00:02:08):

What if somebody had a uterine ablation? Again, the bleeding may stop, but the hormone production doesn’t stop. What if someone has an IUD? Again, the periods may stop, but they’re still not in menopause necessarily because of that.

Laila Agrawal, MD (00:02:24):

And then, certainly when people go through a period of illness, surgery, many other things, there can be a change in periods or even periods can stop without it actually being menopause.

Laila Agrawal, MD (00:02:37):

And then what about the impact of cancer treatment? There’s many things that come along with breast cancer treatment that can impact hormone levels, having periods, menstrual bleeding, or menopause. So let’s talk about that.

Laila Agrawal, MD (00:02:52):

Number one: What about chemotherapy? If a person is premenopausal and receives chemotherapy, that can impact ovarian function. Endocrine therapy, and I’m going to kinda go through this a little bit more in a few slides, but that can either serve as hormone-blocking treatment or hormone-lowering treatment as part of breast cancer management.

Laila Agrawal, MD (00:03:15):

And then some people undergo removal of the ovaries as a component of a cancer treatment, and that can cause a surgical menopause, if someone’s premenopausal and then has their ovaries removed.

Laila Agrawal, MD (00:03:27):

So let’s talk about chemotherapy. If somebody is premenopausal and goes through chemo, they have a risk of developing menopause as a result of that, and that varies widely. It depends on the age of their person, their underlying hormonal state, what type of chemotherapy they got, the dose, the duration, all these different factors. So there can be a really wide range of the likelihood of menopause after chemotherapy.

Laila Agrawal, MD (00:03:57):

And another thing to mention, if somebody gets chemotherapy, periods can stop for a while, but then they can resume. So ovarian function can still resume even if someone hasn’t had a period for over a year after chemotherapy.

Laila Agrawal, MD (00:04:13):

Endocrine therapy is a way to work on the hormonal pathway.

Laila Agrawal, MD (00:04:22):

Tamoxifen is a pill, it’s a selective estrogen receptor modulator, a SERM. Many people ask me, Will this put me into menopause? Does this cause menopause? And tamoxifen, if a premenopausal person takes tamoxifen, it does not induce menopause. However, periods can stop, and there can be symptoms that are menopausal symptoms.

Laila Agrawal, MD (00:04:46):

So tamoxifen is an effective treatment for both pre- and postmenopausal women with breast cancer. And the side effects are menopausal symptoms.

Laila Agrawal, MD (00:04:56):

Aromatase inhibitors, on the other hand, work in a different mechanism. They block the conversion of a kind of precursor hormone into estrogen. And they are only effective if a person is postmenopausal or premenopausal and has a method to suppress the ovarian function.

Laila Agrawal, MD (00:05:16):

That brings me to ovarian function suppression. This is something that can be given as an injection to temporarily stop the ovarian function. So this I would consider a temporary medical menopause that lasts while the effect of the medicine is in someone’s system.

Laila Agrawal, MD (00:05:34):

And then when the medicine is stopped, if the ovaries are still able to produce hormones, naturally they will be able to. And if someone has gone through menopause in that time period, then they may not be producing hormones after that from the ovaries.

Laila Agrawal, MD (00:05:48):

Sometimes people have removal of the ovaries. So why would this be recommended? Or why would this be done? For some people, they may be to have a genetic mutation that predisposes to ovarian cancer, and so ovaries can be removed as a way to reduce the risk of an ovarian cancer to develop. For other people this might be a method of stopping ovarian function as part of the endocrine therapy plan. And then there might be a reason that’s not related to a breast cancer diagnosis or a cancer risk reduction option. So there could be a different gynecological reason.

Laila Agrawal, MD (00:06:27):

In addition to removal of the ovaries, sometimes one of the options is actually removal of the fallopian tubes only without the ovaries. And this is done at times because it can still reduce the risk of what we call ovarian cancer, even removal of the tubes because some ovarian cancers can initiate in that tissue, without removing the ovaries and without causing a surgical menopause at that time.

Laila Agrawal, MD (00:06:57):

This sort of lays the groundwork for different scenarios of hormonal changes, how this relates to cancer treatment, and what we’re really talking about when we’re talking about menopause and menopausal symptoms.

Laila Agrawal, MD (00:07:11):

Now talking about what are these effects. So menopausal symptoms, there’s a wide range. These are not all of the symptoms that people might experience. But some of the common ones are going to be hot flashes, night sweats, muscle aches or pains, joint aches or pains, sometimes people describe brain fog or this foggy thinking, neurocognitive changes, mood changes, sleep changes, and then sexual health.

Laila Agrawal, MD (00:07:36):

So today I’m going to focus on just a few of these symptoms and talk about strategies to manage this. I’m going to talk about hot flashes and joint aches, and then later we’ll go into detail about sexual health also.

Laila Agrawal, MD (00:07:50):

So hot flashes and night sweats, these are common symptoms that can occur as a result of medicines that are used to treat breast cancer. So we see these in women taking tamoxifen and aromatase inhibitor. And basically these are one of the common side effects.

Laila Agrawal, MD (00:08:08):

When I’m talking about managing side effects, the first thing that we always think about are what are lifestyle modifications or behavioral modifications that might be able to help. Sometimes people will relate that hot flashes have certain triggers. So if there is a correlation, and sometimes those are foods, for example, caffeine or spicy foods, or different things like that, avoiding or recognizing triggers for hot flashes. Exercise is an important component of healthy lifestyle overall and is key to managing many of these side effects.

Laila Agrawal, MD (00:08:44):

And then there is a treatment called acupuncture. And this has been studied for people with breast cancer who are, who are having hot flashes, and there’s results. Different trials, some show it helps some show it didn’t help, but this is one of the things that can be tried to manage hot flashes without medication.

Laila Agrawal, MD (00:09:06):

And another thing that actually has shown benefit is something called cognitive behavioral therapy. And this is sometimes delivered in group settings and has been shown to reduce the impact of hot flashes on how somebody feels.

Laila Agrawal, MD (00:09:22):

So now let’s go into medication options. These are what are called nonhormonal medications to manage some of these menopausal symptoms that people may be getting.

Laila Agrawal, MD (00:09:32):

One of the options falls under a category of antidepressants, but they can actually use, not for their antidepressant properties, but to reduce the hot flashes. There’s a range of different antidepressants that can be prescribed depending if somebody is taking tamoxifen or if somebody is taking an aromatase inhibitor. There are some interactions between certain medications and tamoxifen, so that has to be selected carefully. And then for some people, these medicines, they are antidepressants, so they also can help with mood symptoms and sometimes help with joint symptoms too. And they can have different side effects as well. And for certain antidepressants, some of those side effects include sexual dysfunction.

Laila Agrawal, MD (00:10:19):

The next medicine I’m going to talk about is called oxybutynin. This is a medicine that was originally used as a medicine for bladder leakage. So someone who had urinary incontinence might be prescribed this medication. But now we know that it may also have benefits in reducing hot flashes, and we can use this even at a low dose, which would be 2.5 milligrams, twice a day. And it can reduce the symptoms of hot flashes and sweating. Because of the type of medicine it is, it can cause side effects like dry mouth, dry eye, and because it was treating leaky bladder, if someone didn’t have leaky bladder, they could have difficulty starting their urination. So we always kind of balance what is somebody experiencing and then what what medications can we use to manage this. This is one that can also be used if somebody’s having both leaky bladder symptoms and hot flashes, it could be a useful option.

Laila Agrawal, MD (00:11:10):

There are some risks of long-term cognitive impairment, especially in patients who are considered elderly. And so I do use that cautiously in patients who are older.

Laila Agrawal, MD (00:11:26):

The next treatment for hot flashes is gabapentin. Gabapentin is actually a neuropathic pain medicine. So it helps for a neuropathy type of pain is the original use of that medication. But it can also reduce hot flashes and night sweats. One of the side effects of this medicine is drowsiness. And sometimes that can be actually used to advantage if people are waking up at night, having trouble sleeping, having night sweats that are waking them up, sometimes this medicine can both reduce the hot flashes and night sweats and help with sleep a little bit at night.

Laila Agrawal, MD (00:12:04):

So sometimes we sort of look at what is the pattern. Are these more during the day? Are they more at night? How is the sleep? And try to see which of these medicines makes the most sense.

Laila Agrawal, MD (00:12:14):

Another medicine that is sometimes used for managing hot flashes is called clonidine. And this is actually a blood pressure medicine and in some studies has shown to reduce hot flash incidents but can have impact of course on blood pressure and for some dry mouth, constipation, other side effects like that.

Laila Agrawal, MD (00:12:34):

Now we have some newer medications that can treat hot flashes. And these are really interesting because these are primarily intended to treat hot flashes. Fezolinetant was the first medication in this class that was FDA approved 2 years ago. And this was actually approved not specifically for people who had breast cancer, but who were experiencing menopausal vasomotor symptoms. And the studies that led to the approval did not include people who had breast cancer. In terms of side effects, it’s known that there’s a low chance of impact to the liver. And so monitoring liver enzymes is part of this follow-up.

Laila Agrawal, MD (00:13:17):

While people with breast cancer were not included in this, in the studies that led to this approval, it is sometimes discussed and mentioned as an option for people who have breast cancer who are experiencing hot flashes. And there is a phase III trial in patients with breast cancer that is currently ongoing.

Laila Agrawal, MD (00:13:37):

There’s another medication that works in a similar way called elinzanetant. And this is not currently FDA approved in the U.S., but they have specifically investigated this medicine in people with breast cancer. And it was found to reduce the number of hot flashes per day over placebo. And so we’ll be watching this very closely to see if this is approved and if this becomes an option specifically for people with breast cancer. But it’s really encouraging to see new research, new mechanisms to combat hot flashes.

Laila Agrawal, MD (00:14:16):

The next side effect or symptom that I’m going to talk about is musculoskeletal symptoms. And this is a really big one because a lot of people experience muscle pain, joint pain, stiffness that can be extremely disruptive to their lives. The incidence varies, but this is something we know, we see this very commonly, probably more so on aromatase inhibitors than tamoxifen, but it can certainly happen with both.

Laila Agrawal, MD (00:14:42):

And this is one of the reasons that sometimes people stop taking the medication. So being able to manage it and improve it is important to help people stay on their medicines. As always, lifestyle interventions are key, and specifically for musculoskeletal symptoms, exercise is really important. And exercise, they have looked at this, it can reduce pain, and among the people who exercised more, there was more pain reduction compared to those who exercise but not as much.

Laila Agrawal, MD (00:15:15):

So this is really one of the first initial treatments for the joint aches and pains. And acupuncture, again, has also been studied for this and may reduce pain caused by aromatase inhibitors and medicines like that. Also yoga has been studied too as a specific form of exercise and this can also help with the musculoskeletal symptoms.

Laila Agrawal, MD (00:15:40):

And just practically speaking many doctors will employ what’s called a switch therapy. So if somebody is on one aromatase inhibitor, like letrozole for example, they may say, OK, let’s switch to a different aromatase inhibitor like anastrozole and exemestane. Just in my own experience, making a switch sometimes can have a dramatic change on how somebody feels with one of these side effects.

Laila Agrawal, MD (00:16:07):

Some people also employ what’s called a brief break or a washout period. That’s always an individual discussion with somebody’s oncologist, but a break or a washout sometimes helps to diminish the symptoms so that someone actually can exercise and then start on a new one as a way to smooth out those side effects.

Laila Agrawal, MD (00:16:29):

In terms of medications, nonsteroidal anti-inflammatories are effective in reducing pain, but of course, using a medicine like that long term on a regular basis is limited because of other side effects that can develop.

Laila Agrawal, MD (00:16:41):

And then duloxetine is a medication that’s also in an antidepressant category, but it has been shown to improve joint pain, stiffness, that interference that pain is having on people’s lives and their functionality. There is an interaction with tamoxifen, so if somebody is on tamoxifen, this might not be the the choice for them.

Laila Agrawal, MD (00:17:03):

Then there’s supplements. Some of these supplements have been studied in randomized trials, and one of them is actually called tart cherry, which showed an improvement in pain symptoms. So this is one of the options that we can discuss in terms of a non-prescription or a supplement medication.

Laila Agrawal, MD (00:17:23):

There were other supplements that have been looked at with research as well, including vitamin D, E, omega acids that may not have been found to be effective. And the glucosamine, interestingly, there is a little bit of data on that in terms of what’s called a single arm trial, meaning everybody took the same thing, which did show some reduction, but we always like to see a group not taking it and a group it to understand if this is beneficial. In my own experience, some of my patients really do find that glucosamine is helpful to their joint pain.

Laila Agrawal, MD (00:17:58):

So why don’t we pause here and just see if there’s any questions before moving on to the next section.

Jean Sachs, MSS, MLSP (00:18:05):

That’d be great. I was just going to say there are definitely questions. But first: Will you be addressing hormone replacement therapy in the next section or should I ask those questions now?

Laila Agrawal, MD (00:18:17):

I have a slide at the very end about hormone replacement therapy, so we can ask those at the end.

Jean Sachs, MSS, MLSP (00:18:22):

OK, great. One question is around drug interactions. So do you have what are the names of either an SSRI or an SNRI that does not interact with an AI?

Laila Agrawal, MD (00:18:41):

So most of them will not interact with the aromatase inhibitors. It’s really more the tamoxifen that we have to be really picky about which of the medications that we look at in terms of the drug interactions.

Laila Agrawal, MD (00:18:55):

With any new prescription, obviously you have to talk with your doctor about what medicines you’re on and if there are any drug interactions. But the interactions that I’ve mentioned, I’m really more concerned about them with tamoxifen.

Jean Sachs, MSS, MLSP (00:19:08):

OK, great. And someone, I know you were using the chemical names, but Veozah was the drug you were referring to that’s been approved?

Laila Agrawal, MD (00:19:18):

Yes. Fezolinetant is the one that is FDA approved in the U.S. but did not include participants with breast cancer in their trial.

Jean Sachs, MSS, MLSP (00:19:26):

In their first, right. But they’re doing a trial now. Another one, I don’t know if it has a brand name yet, that might be approved, right?

Laila Agrawal, MD (00:19:34):

Right. So the elinzanetant is not FDA approved. It is not approved in the U.S., but that is the trial that has specifically looked at individuals with breast cancer.

Jean Sachs, MSS, MLSP (00:19:46):

So we should keep our eye out for that.

Jean Sachs, MSS, MLSP (00:19:47):

Someone’s asking that she’s heard some negative aspects of taking gabapentin, in that there was something controversial. Do you have any information on that?

Laila Agrawal, MD (00:19:59):

Well, I think each of these medicines, I’m just briefly going over them, but if somebody is considering any of these medicines, certainly they will bring it up with their medical teams and go through all the different side effects in general.

Laila Agrawal, MD (00:20:10):

So gabapentin in particular can have different side effects. I think I mentioned sedation or sleepiness is one of them. For some people it’s swelling or weight gain. And then there’s going to be a list of other potential side effects as well.

Laila Agrawal, MD (00:20:26):

That’s one of the reasons that sometimes that medication is more helpful at a bedtime dose, whereas other times people will take it throughout the day. These are all sort of tools in the toolbox, and trying to find which medication might be most beneficial to which person. And some of that may also depend on how an individual responds to that medicine. Does it help with their symptom? And do they have any side effects on it as well?

Jean Sachs, MSS, MLSP (00:20:52):

OK, great.

Jean Sachs, MSS, MLSP (00:20:53):

There’s a lot of questions about do menopausal symptoms ever get better. With natural menopause, I think there is the sense that over time they may get better, that’s not always true. But if you are taking an AI or maybe ovarian suppressed, do you find that symptoms do taper over time?

Laila Agrawal, MD (00:21:15):

The most important thing is everybody is going to have their own experience with it, and there’s not really a universal pattern that people will go through. But I will say in my experience treating many, many patients with all these different forms of endocrine therapy, sometimes the side effects are more severe in the beginning and then can lessen with time as well. I think some of that might have to do with people incorporating more lifestyle interventions or the different dietary modifications that are helpful, exercise. But also I think the side effects can on their own lesson a little bit.

Laila Agrawal, MD (00:21:55):

Now everybody is going to be different in terms of their own experience and the time course and the severity and things like that. But I do think it’s a common pattern where the side effects are more intense in the beginning, and then maybe several months or 6 months in, I’ll have people come in and we’ll be going through the note, “Oh, last time you were telling me about the hot flashes and the joint aches.” And they’ll say. “They don’t really bother me that much anymore.” So sort of this lessening over time is something that we frequently see.

Jean Sachs, MSS, MLSP (00:22:29):

OK. And then for people that are ovarian suppressed with Lupron or another drug, the question is, is that experience different than someone who is going through natural menopause?

Laila Agrawal, MD (00:22:44):

Well, certainly when ovarian suppression is initiated, typically it’s because somebody is premenopausal. And the action of it is to abruptly stop the ovarian function. So rather than natural menopause, which can have hormonal changes over a period of years, this is basically 1 week to the next, it’s an abrupt menopause at a younger age. For many, those symptoms are more intense and more sudden because of the way that that medicine works and the time point in somebody’s life when it’s initiated.

Jean Sachs, MSS, MLSP (00:23:19):

Yeah. OK. And the last question, and then we’ll get to your second half, which is sexual health, and that will help us address some of the other pending questions. But is it better to take tart cherry supplements or actually drink the tart cherry juice?

Laila Agrawal, MD (00:23:35):

The actual study that looked at tart cherry, I believe used a syrup. So it wasn’t really the juice, it was more of a concentrate. And that’s harder to find. I think most of my patients that use that will find a supplement pill in general is more readily available.

Jean Sachs, MSS, MLSP (00:23:53):

OK. Alright. Well thank you. I’m going to let you do your second half of the presentation, so keep putting your questions in the Q&A.

Laila Agrawal, MD (00:24:00):

Now we’re going to move into the next section, which is all about sexual health. This is really a very common set of side effects and symptoms that people can experience through breast cancer treatment and beyond. And what I’m going to talk about is that some of these things are what I would consider to be menopausal effects, which are attributable to changes in hormones. But then there are also so many other things that might come along with breast cancer diagnosis and treatment that can also impact sexual health.

Laila Agrawal, MD (00:24:34):

So whenever I talk about sexual health I put this out in a context of what’s called a biopsychosocial framework. That means biological-physical things, mental-emotional things, and social-interpersonal things. They all come together and influence someone’s experience with sexuality and cancer treatment can disrupt all of those different areas.

Laila Agrawal, MD (00:24:58):

So when we’re talking about sexual health, some of this is called the genitourinary syndrome of menopause. So that means because of lowering of hormones like estrogen, there are impacts to the pelvic genital urinary health. And that includes vulvar, vaginal dryness, thinning, less blood flow, less lubrication, narrowing of the vagina, shortening of the vagina, lessening of the elasticity, pelvic floor dysfunction, that has to do with the muscles that support the pelvic organs. And they need to work together to relax at the right time and to be strong enough. And when that balance is off, it can cause a variety of different things, including pain with intercourse.

Laila Agrawal, MD (00:25:43):

Sexual response is arousal, desire, orgasm. That can be changed by hormonal changes and other things. Body image changes occur, relationships are impacted. So we’re really talking about many different aspects of sexual health.

Laila Agrawal, MD (00:26:02):

The genitourinary syndrome of menopause, we mentioned some of these, the dryness, decreased lubrication, it can contribute to pain or discomfort with sexual activity, sometimes even bleeding. If there’s any bleeding that needs to be evaluated, that’s an important symptom. There can be lowering of arousal.

Laila Agrawal, MD (00:26:20):

Really it’s important to understand that these changes are actually really important to someone’s health, regardless of whether they are sexually active or ever wish to be sexually active in the future because people can have irritation, burning, itching of the vulva, vagina. This can even impact what clothes people wear, what activities they do, discomfort with sitting, wiping all these just everyday activities. Burning or discomfort with urination, frequency, and urgency. So all of these are encompassed in what’s now termed the genitourinary syndrome of menopause. And these can all be things people experience after breast cancer treatment with hormonal effects.

Laila Agrawal, MD (00:27:00):

For the symptom of dryness, vaginal and vulvar dryness, one of the first steps in treatment involves using moisturizers.

Laila Agrawal, MD (00:27:09):

It’s key to understand that moisturizers are for the health of the tissue, they’re meant to be used on a regular basis regardless of sexual activity. So I hear that really often. We might talk about this, and then somebody uses a moisturizer prior to intercourse and it doesn’t help that much. But really it’s because they’re intended to be used on a regular basis. So typically this will be three to five times per week, every day is fine. And now there’s many products that can contain hyaluronic acid in it, which can pull in and keep in more moisture to the tissue.

Laila Agrawal, MD (00:27:44):

Lubricants on the other hand are intended to reduce pain and discomfort from friction. And so there are some products that both work as a moisturizer and a lubricant. But in general, I have people think of these separately.

Laila Agrawal, MD (00:27:57):

And there’s lubricants that are water based. You have to be really careful with which products you choose because many of them don’t have the right pH or the right concentrations. And certainly we want to be very careful about what is added to that product because there’s a lot of things out there. They say they’re tingling, warming, flavored, but really what might happen is they might burn and actually make matters worse.

Laila Agrawal, MD (00:28:21):

There’s another type of lubricant called a silicone-based lubricant, and that is for many people longer lasting. They do caution it may stain, and they do caution to be cautious using it with a silicone covered toy or something else like that.

Laila Agrawal, MD (00:28:39):

But in general: Moisturizers on a regular basis for the health of the tissue. Lubricants, either a well-selected water-based or a silicone-based lubricant.

Laila Agrawal, MD (00:28:51):

And here are some brand names of products. Natural oil moisturizers, they can help the symptom of dryness. And you saw on the list, genitourinary syndrome of menopause has many more things besides dryness. But if someone’s experiencing mild dryness, these can be helpful.

Laila Agrawal, MD (00:29:11):

Many times now, I just jump straight to those hyaluronic acid-containing products because they probably have the greatest moisturizing benefit.

Laila Agrawal, MD (00:29:19):

And then vaginal hormones. The cause of these symptoms is the lowering of the estrogen and the impact that it has on that tissue. And so in general, a low-dose vaginal estrogen or vaginal hormone is the treatment for genitourinary syndrome of menopause. But of course for people who have, especially a hormone receptor-positive breast cancer who are be being treated with endocrine therapy, we need to understand what are we doing when we’re treating with a vaginal hormone, even a low-dose vaginal hormone. Here I’ve listed just a few different products that are available, prescription products that are available to treat genitourinary syndrome of menopause.

Laila Agrawal, MD (00:30:08):

Now I’m going to go through in a little bit of detail, what do we know and how do we approach the use of low-dose vaginal hormones in somebody who has a hormone-positive breast cancer.

Laila Agrawal, MD (00:30:18):

Many medical societies have put on guidelines that address this. ASCO, which is the big medical oncology or oncology organization, says women who have hormone-positive breast cancer and conservative measures are not working, can use a low-dose vaginal estrogen (sorry, my slides keep skipping ahead here) after considering discussion of risks and benefits, and that’s pretty much what these other organizations, the ACOG, which is the gynecology society, as well as the Menopause Society and International Society for the Study of Women’s Sexual Health.

Laila Agrawal, MD (00:30:55):

Basically if non-hormonal methods are not effective, discuss risks and benefits, and you can utilize these products through what’s called shared decision making.

Laila Agrawal, MD (00:31:06):

Shared decision making basically means that we explain what is known about this, what is not known, how does that fit into somebody’s specific situation, and how do they feel about that information.

Laila Agrawal, MD (00:31:21):

Oh, and one more American Urological Association also just this year, I believe, put out their guideline statement on genitourinary syndrome of menopause. And it’s wonderful that they specifically addressed breast cancer and, again, shared decision making.

Laila Agrawal, MD (00:31:37):

Some of the data we have about vaginal estrogen use and breast cancer comes from a study called the Danish Cohort Study. So this was published in 2022, and it looked at what had happened in the past, people who had breast cancer, who received vaginal estrogen, who didn’t, and what were their recurrences overall.

Laila Agrawal, MD (00:31:57):

Looking at the whole group of people, with breast cancer there was no difference in recurrence or mortality among those who used vaginal estrogen in those who didn’t. However, in the subgroup that used aromatase inhibitors, they did see a higher risk of recurrence, but not of mortality, which is survival.

Laila Agrawal, MD (00:32:16):

This study in many ways doesn’t really align with the way things are done today because number one, people with lower-risk cancers didn’t receive any endocrine therapy in that time period, which was decades ago. Number two, this preceded HER2 testing. So they weren’t testing for it, they weren’t treating for HER2-positive breast cancer, and that could influence the outcomes or the recurrences. So it’s good to know this information, but in my opinion, it doesn’t a hundred percent apply to the way things are done today.

Laila Agrawal, MD (00:32:50):

After that, a couple additional trials were published. So this one here looked at a group of over 40,000 patients who were diagnosed with breast cancer and then were diagnosed with genitourinary syndrome of menopause. About 5% of them were treated with vaginal estrogen. And here’s where there’s some information missing. They didn’t have the information on everybody about whether it was hormone receptor positive or hormone receptor negative. But they did know for about 10,000 people that they had hormone receptor-positive breast cancer. And out of those about nearly 4% had vaginal estrogen. And overall the risk of breast cancer recurrence was comparable between those who had vaginal estrogen and those who didn’t in the overall population. So that was reassuring. And that also held true among those who had estrogen receptor-positive breast cancer. So that is reassuring as well.

Laila Agrawal, MD (00:33:51):

However, the question about what about aromatase inhibitors and vaginal estrogen at the same time, in my opinion, this study was extremely limited in being able to pick out the people who were taking them at the same time. They did report a higher risk of recurrence in that group, but the numbers were so small that it’s not really valid to make a broad generalization.

Laila Agrawal, MD (00:34:13):

And then a third study, this one looked at survival, or mortality. And the reason is in Scotland and Wales, they have databases where they can say, OK, here are all the people who had breast cancer. These are the ones who were prescribed vaginal estrogen. And then this is whether or not they are surviving at a certain time point. And here we see that vaginal estrogen users did not have a higher risk of passing away of breast cancer. That means there was no higher risk of mortality with vaginal estrogen.

Laila Agrawal, MD (00:34:49):

And when you look at these numbers, actually this is lower, it was a lower risk of mortality. And then they picked out estrogen receptor-positive breast cancer, no difference. And then they picked out the people who were on aromatase inhibitor. And again, this is actually a lower risk. This doesn’t mean that vaginal estrogen lowers the risk, but what it does mean is this is very reassuring that we can look at this and say, using a low dose vaginal estrogen does not hurt anybody’s life expectancy.

Laila Agrawal, MD (00:35:19):

This particular study didn’t look at recurrence. Everyone wants to know about recurrence, not only survival, but this study only reported out on survival.

Laila Agrawal, MD (00:35:29):

And then earlier this year, there was yet more information added to this using a database called the SEER database. It looked at women who were 65 years and older. They found over 18,000 patients with breast cancer, looked at the ones who used vaginal estrogen versus the ones who didn’t, and actually they said the ones who used vaginal estrogen, they actually had an increased overall survival, an increased breast cancer survival, and the longer they used it, the better the survival was. So this study actually did not say anything about were they taking aromatase inhibitors and vaginal estrogen at the same time. But again, it adds to what we do know. This was presented as an abstract, so hopefully we’ll get more information if they report out a full paper in the future with this data.

Laila Agrawal, MD (00:36:23):

The concern that people might have about vaginal estrogen is, is it going to be absorbed into the bloodstream, and if so, what is that going to do for cancer recurrence risk. There’s different studies that have looked at this. This is just one graph from a study that looked at what is called ultralow doses, or 4 microgram doses of vaginal estrogen in the orange, and then show after it was given, how many hours after the administration, what did the hormones do. So these higher doses that are not commonly used anymore did have spikes in estrogen but the lower doses, 10 and 4, had very small doses on the first day and then even smaller by day 14.

Laila Agrawal, MD (00:37:08):

This information here is taken from a study on people who did not have breast cancer who are not on aromatase inhibitors, but it’s showing, especially with these what I would call ultralow doses, that systemic absorption seems to be very low.

Jean Sachs, MSS, MLSP (00:37:25):

Sorry, can I ask to go back to that slide? I’ve never seen that, and I’m just curious. So even with the lower doses, is the efficacy the same? Is it still as beneficial?

Laila Agrawal, MD (00:37:37):

It’s still beneficial, yeah.

Laila Agrawal, MD (00:37:40):

It may not the same, but it’s an FDA available dosing, not specifically for people who have breast cancer, but this is a prescription dose, the 4 micrograms.

Jean Sachs, MSS, MLSP (00:37:51):

Yes.

Laila Agrawal, MD (00:37:51):

And it’s an effective dose.

Jean Sachs, MSS, MLSP (00:37:53):

OK. Sorry. Thank you.

Laila Agrawal, MD (00:37:54):

Yeah, this is an available and effective dose.

Laila Agrawal, MD (00:37:58):

What about other hormones? So there’s another hormone that is called DHEA, and this is a prescription product that’s available, it’s called prasterone. And there was actually a trial looking at postmenopausal women with breast or gynecological cancers, and they could be taking tamoxifen or aromatase inhibitors. They were given this vaginal DHEA versus a plain moisturizer as the control. And they found that estrogen level, estradiol, was increased in people who use this DHEA. However, this is a precursor hormone that gets converted into estradiol. So the people who are on aromatase inhibitors, the enzyme that blocks that step, they did not have an increase in estradiol. So this is another, it’s a different hormone that is on the list of options that we can discuss through a shared decision making context. So this is vaginal DHEA or vaginal prasterone.

Laila Agrawal, MD (00:38:59):

Now I’m going to move past the vaginal estrogen question into these other symptoms. Some people may not be experiencing the dryness or they may have had it and it was treated with moisturizers or low dose vaginal products but are still experiencing pain with penetration, with vaginal penetration. And this could be something called pelvic floor dysfunction. And sometimes, often I will say, we actually see people have what’s called an overactive pelvic floor, meaning that the muscles are hyperactive, or too active, and might be too tight. And that can cause pain with penetrative intercourse and it can also cause urinary retention or urinary leakage and constipation. And then other things, pelvic pain, hip pain, back pain, can also be a symptom of that.

Laila Agrawal, MD (00:39:52):

Other people have what’s called an underactive pelvic floor, and that’s when there could be symptoms or issues like organ prolapse or also urinary incontinence.

Laila Agrawal, MD (00:40:03):

And so for pelvic floor dysfunction we really work closely with pelvic floor physical therapists. So these are specialized physical therapists on this part of the body, and they can do treatments that may involve stretching, strengthening, biofeedback, other types of treatments. And one of the things that’s often recommended or utilized is something called a progressive vaginal dilator, which is a series of cylindrical devices that start at a smaller length and caliber and then increase. And this is a tool that can be used to help with symptoms of pelvic floor dysfunction. And sometimes these are recommended to be used for 5 to 10 minutes per session a couple times a week. And that can help with some of the symptoms of pelvic floor dysfunction.

Laila Agrawal, MD (00:40:53):

So typically if I’m talking to somebody about this, we will refer to pelvic floor physical therapy and work together to devise a treatment plan.

Laila Agrawal, MD (00:41:02):

I think it’s really important to emphasize that if there’s a pelvic floor issue, it could be one problem or it could be something different. And so I don’t typically tell people to do exercises on their own without actually getting diagnosed with what is the issue and what are the right exercises to be doing here.

Laila Agrawal, MD (00:41:21):

Another big issue is what’s called sexual response. So that has to do with desire to have sex, arousal, which is mental and physical, and then orgasm. And really this is ... We actually did a study that we published, and this was actually the most common sexual concern that the that was reported in our study was low desire.

Laila Agrawal, MD (00:41:45):

When we’re talking about this, one of the first steps is just understanding that I say desire comes in two flavors, spontaneous and responsive. And even if somebody has a decrease in spontaneous desire, they often can still work with what’s called responsive or reactive desire. And that basically means instead of desire coming first and then leading to arousal, things that increase arousal may come first and then the desire comes as a response or as a reaction to that.

Laila Agrawal, MD (00:42:17):

Another important thing is to review the medication list. There’s lots of medicines that may negatively impact desire and sexual response. And then there’s other, other tools that have been around, some for decades, like the sensate focus is a technique that couples can do together, often with the guidance of a sex therapist working through different issues with them. Mindfulness is getting more and more attention on how important it is in sexuality. Sometimes people’s thoughts will be going in all different directions and not be able to really focus on the moment. And so practicing techniques of mindfulness outside of sexuality can be helpful then to employ to help with sexual response.

Laila Agrawal, MD (00:43:06):

And then there’s a particular type of a mental health professional that’s called a certified sex therapist, and they have additional expertise in helping people who are confronting issues or concerns about sexuality and they can help with individuals and they can help with couples as well.

Laila Agrawal, MD (00:43:26):

And then there’s several medications that have been shown to have benefit in sexual response. And I will say, all three of these would be considered off-label for individuals diagnosed with breast cancer. The first two, flibanserin and bremelanotide, they are both FDA approved for premenopausal women who have a condition called hypoactive sexual desire disorder, which according to that definition, the problem is not related to a medical condition or a medication.

Laila Agrawal, MD (00:43:57):

However, flibanserin, which is a pill taken at bedtime, so every night, it has been studied in people with breast cancer in a single-arm study and did show improvements in sexual outcomes when people took this medication. One of the side effects is it can make people sleepy, but actually in that study it helped people sleep better. They actually slept for 1 extra hour a night with that medication.

Laila Agrawal, MD (00:44:23):

We would love to see more data or more research come out on this with a randomized trial, but it is one of the tools in the toolbox or one of the options that can be considered.

Laila Agrawal, MD (00:44:36):

Bremelanotide, to my knowledge, has not been studied in individuals with breast cancer, so there’s really less information about that. But this is a self-injected medication, so someone would give themselves an injection. And some of the side effects on that are going to be nausea, which you don’t really want to encounter that if you’re trying to have sex, but that is one of the options. And then that can be managed with nausea medications as well.

Laila Agrawal, MD (00:45:00):

And then testosterone, there’s a good amount of data on testosterone in general in terms of a medicine that can help with sexual desire. However, the overlap and really the understanding of how does this impact people who have been diagnosed with breast cancer. Really there’s not so much solid data that we can counsel people on.

Laila Agrawal, MD (00:45:22):

So those are some medical options, but I always tell my own patients that these medications are not going to really overcome the things listed in the top here, like understanding desire or working with a counselor or things like that. But sometimes, on occasion they can be helpful tools as well.

Laila Agrawal, MD (00:45:42):

Body image is a really important issue as well. And this is one that so many aspects of breast cancer treatment can impact somebody’s body, and people can experience changes in how they feel about their body as well.

Laila Agrawal, MD (00:45:58):

Multiple things will go into how this can be addressed, but one of the important things on there is understanding that this is something that, if you’re working with a counselor, you can bring up thoughts about body image, that this is something that’s very important, and that this is something that can improve with a number of different things, including counseling.

Laila Agrawal, MD (00:46:19):

And then relationships. Relationships are important when it comes to sexuality, of course, and going through cancer treatment, there are so many changes and issues that can arise with a relationship and the partner going through perhaps their own medical issues, their own mental and emotional issues as well. And so focusing on communication and sometimes employing use of counselors or sex therapists can be very helpful too.

Laila Agrawal, MD (00:46:49):

Here I’m going to briefly touch on systemic hormone therapy. So I talked a lot about what I call local vaginal hormones, low dose, but systemic hormone therapy is hormonal treatments that are meant to affect the whole body.

Laila Agrawal, MD (00:47:05):

This is typically not recommended after somebody has been diagnosed with a hormone receptor-positive breast cancer. There might be variation in what people are recommended after being diagnosed with a hormone receptor-negative breast cancer. But this would always be approached in the context of what we call shared decision making: understanding the risks, understanding the benefits, and how something like this would fit into an individual situation.

Laila Agrawal, MD (00:47:32):

And then I want to call out what I would consider to be a couple special circumstances. One thing is we talked at the beginning of the presentation that sometimes people are recommended to have their ovaries removed, not as a method to treat the breast cancer, but to reduce ovarian cancer risk. For example, if someone had a triple-negative breast cancer and they were found to have a BRCA mutation or other mutation that confers an increased risk of ovarian cancer. So if you think about it, if that person didn’t have their ovaries removed, the ovaries would still be producing the regular premenopausal level of hormone. But if they’re removed as an ovarian cancer prevention, that’s a different circumstance than if it was part of the breast cancer treatment.

Laila Agrawal, MD (00:48:21):

We’re focusing on individuals who have been diagnosed with breast cancer, but there’s another category that’s called previvors, where somebody might have a genetic mutation that predisposes to a cancer risk but has not been diagnosed with cancer themselves and may undergo treatments that could induce a premature menopause like removal of the ovaries. And that would be a different circumstance as well.

Jean Sachs, MSS, MLSP (00:48:45):

Thank you. And yes, I’m going to try to try to get through some of these questions.

Jean Sachs, MSS, MLSP (00:48:51):

Just the first one, which is kind of overarching, I mean you are so knowledgeable, but do you think most breast medical oncologists have this depth of knowledge? Do gynecologists? Where do people go to get this kind of information if they’re not finding it with their own medical oncologist?

Laila Agrawal, MD (00:49:09):

Is this specific to sexual health?

Jean Sachs, MSS, MLSP (00:49:11):

Yeah. Well the whole thing, everything you’re covering, which is a lot.

Laila Agrawal, MD (00:49:15):

I would say in terms of managing the side effects of tamoxifen or aromatase inhibitors, that does fall under what should be the wheelhouse of a medical oncology team. And what I would really put out there is that I think it’s really important to communicate not only what side effects you’re having, but how are they impacting your life. Because that really influences which path it would be best to go down for an individual.

Laila Agrawal, MD (00:49:44):

So whenever we’re talking about side effects, it’s first and foremost important to understand what is the amount of benefit that anybody is having from a cancer treatment, what are the other options. Can we switch to a different aromatase inhibitor? Can we switch to tamoxifen? And then what are the mitigation strategies, or what other things could be done to reduce the side effects? And there’s many options on the table and for each individual person, that path might look a little different. But I think it’s important to to share the experience, and I hope that will help to get some answers and get at least some options.

Jean Sachs, MSS, MLSP (00:50:26):

OK, that’s great. And LBBC, we have a lot of resources on our website, and there’s a lot in the chat. So I hope people are continuing to learn from each other.

Jean Sachs, MSS, MLSP (00:50:33):

There’s a lot of questions about weight gain, whether someone is on an AI or tamoxifen, really struggling. So just any thoughts you have. And some people are saying, will this go away when I go off tamoxifen. What’s been your experience?

Laila Agrawal, MD (00:50:53):

Yeah, so that’s that’s certainly one of the big side effects. I didn’t really touch on it in this talk, but weight gain certainly can happen through cancer treatment with or without the hormonal medications added on top of it. And it can be really challenging.

Laila Agrawal, MD (00:51:09):

First and foremost is the importance of the lifestyle factors, the nutritional changes and the exercise. And those will be beneficial even if they don’t result in the desired amount of weight loss because it can be harder to lose weight on these medications compared to how somebody’s body might’ve responded to that level of nutrition or that level of exercise before.

Laila Agrawal, MD (00:51:33):

I think there’s a lot of interest of course in these GLP-1 medications coming out. Are they going to be effective? Are they safe? This is all evolving and there’s a lot of research interest. And so hopefully in the near future we’ll get more data on how effective are they. There’s some suggestion that they may not result in as much weight loss in people who are on some of these medications, but I think we need a lot more information about it. Certainly, I have a lot of my own patients come ask, “Is it OK for me to go on these medications for weight loss?” And again, we share, there’s just not that much available, but weight loss is a good thing. And understanding what do we know, what do we not know, and how does that fit into someone’s situation at this point in time. I think we’re going to be learning a lot more about utilizing those medications as well.

Jean Sachs, MSS, MLSP (00:52:26):

Yeah, thank you for bringing that up. And it’s certainly something that I think Living Beyond Breast Cancer wants to cover more because we’re getting a lot of questions: Are these medications saved? Should I try it? And now there’s microdosing, so lots to learn.

Jean Sachs, MSS, MLSP (00:52:41):

There are questions. A lot of the participants really liked your slide on the different moisturizers, and of course they wanted you to flip back to it.

Laila Agrawal, MD (00:52:49):

Oh yeah, I’ll flip back to it.

Jean Sachs, MSS, MLSP (00:52:50):

The presentation is available, but if you want to flip it back and if people want to take a picture of it, that would be great.

Jean Sachs, MSS, MLSP (00:52:56):

But are there any specific products, brands that you like? Obviously Bonafide has products. We all get stuff in our inbox and on our feed. But are there, are there specific brands that you like?

Laila Agrawal, MD (00:53:10):

Yeah, these ones down here at the bottom I think are great. Especially this bottom brand here has a range of products. So the ones that I recommend to my patients include the hyaluronic acid-containing moisturizers. And then they also have a moisturizer without hyaluronic acid that can be helpful as well.

Laila Agrawal, MD (00:53:35):

I guess I didn’t really talk about it very much, but these products, some of them come in creams or gels and others come in what’s called a suppository, which is sometimes like a little egg shape device or an egg shaped suppository that you put into the vagina. And it melts with body temperature and then releases the product. Some people prefer the gels or creams because they can be well used on the external vulvar tissue as well, where a lot of symptoms are. Other people feel that’s messy or they don’t like it and they prefer the suppository. So I would say if you try one product and it you don’t like it, there’s a lot of stuff out there. Try another one, try a different form. This one here, the first one listed comes in both a gel or a suppository. And then there’s going to be different price points on the products too.

Jean Sachs, MSS, MLSP (00:54:26):

Yeah, I was just going to say that, all of these, there are different price points. That’s something to pay attention to sometimes. I don’t know if FSA ever covers this, but I know cost has come up as a concern.

Laila Agrawal, MD (00:54:40):

Yeah. And there are, beyond these brands, there may even be a drugstore brand might have a hyaluronic acid-containing suppository,

Jean Sachs, MSS, MLSP (00:54:48):

So that’s what everybody wants to look for. Great.

Jean Sachs, MSS, MLSP (00:54:52):

So this is a question that I think is going to be hard to answer, but I’m going to ask it because I know it’s common. If you were diagnosed with breast cancer just as you were entering menopause it can be really hard to distinguish the list of issues that you suddenly start facing, whether it’s high cholesterol, pre-diabetes, frozen shoulder, weight gain. So how do you separate out, like what is just menopause and then what is the AI that these people might be taking?

Laila Agrawal, MD (00:55:24):

Yeah, so of course that can be really tricky because without stopping the AI, letting it fully wash out of the system and seeing what’s left, there’s really no other way to differentiate what’s what. And of course there’s going to be concern with taking a prolonged gap from a medication in terms of outcomes and an efficacy standpoint.

Laila Agrawal, MD (00:55:44):

I think one important thing to understand is that I cannot emphasize enough how important lifestyle interventions are. And so whether it’s through menopause or through the side effects of medications, changes in lifestyle interventions are going to be important regardless of which one it is. And so the question was how do you differentiate? So without stopping a medication, there’s really not a way to a hundred percent know what’s what. But the same lifestyle changes that are helpful for one, are also helpful for the other.

Jean Sachs, MSS, MLSP (00:56:19):

OK, thank you.

Laila Agrawal, MD (00:56:20):

And also, this isn’t really this topic, but if someone has high cholesterol we know it’s so important to treat cardiovascular risk factors. I sometimes hear people say, “Well, it’s just a side effect, I maybe don’t need to treat it.” Absolutely this is the time that those cardiovascular risk factors such as cholesterol, A1C, glucose metabolism, all of those, blood pressure, they all need to be optimized through a combination of lifestyle and medical interventions.

Jean Sachs, MSS, MLSP (00:56:52):

Thank you.

Jean Sachs, MSS, MLSP (00:56:54):

There’s a question about contraception and what moisturizers, lubricants work with condoms. They’ve had some problems.

Laila Agrawal, MD (00:57:05):

So I think for that one would have to specifically check on the product. They should say whether they’re compatible or not compatible. If someone’s using condoms for pregnancy prevention, then it’s important to check the product specifically and understand what type of condom is being used and if that’s compatible with the product. So for example, oil-based products are often not compatible with condoms because they can cause breakdown potentially. So that’s a really important point to check: What is the product you’re using? Is there a condom being used? And is that compatible?

Jean Sachs, MSS, MLSP (00:57:39):

OK, great. I’m going to just ask a few more.

Jean Sachs, MSS, MLSP (00:57:43):

You addressed this, but I don’t know if you have more to add. If patients have triple-negative breast cancer and are really thrown into some hard menopausal symptoms, is hormone replacement therapy a possibility? I know you said it’s a discussion, but how do you approach your triple-negative patients about this?

Laila Agrawal, MD (00:58:05):

Yeah, there’s not really a clear consensus in terms of can we tell people, “This is safe,” or “No, you can’t have it.” So then there’s going to be what’s the middle ground in between that And that involves a detailed discussion about what do we know in terms of people who had triple-negative breast cancer, recurrence risk. The other factors I would be thinking about personally is going to be: Do they still have their breast tissue? Are we not only concerned about recurrence? Are we also concerned about a new cancer diagnosis as well? And what is the impact of what treatment is being considered on that risk?

Laila Agrawal, MD (00:58:50):

Number two, there’s different forms of hormone replacement therapy or menopause hormone therapy depending on somebody’s age and when this is being applied. Some are estrogen alone, some incorporate progesterone as well. That depends on if someone has a uterus or not. And some of those risks in terms of the specific products are going to be different as well.

Laila Agrawal, MD (00:59:13):

So we’re thinking about: Somebody’s age. Do they still have breast tissue? How long since the diagnosis? Do they have a uterus? What form of hormone therapy is being considered? What duration is being considered? What is the symptom that they’re hoping will get better? Is that the optimal treatment or are there other options that could work for that too? And that’s why there’s not a one-size-fits-all answer to that question. And there are some gaps in what is known.

Jean Sachs, MSS, MLSP (00:59:41):

Yeah, and I appreciate the studies, the Danish study, that you shared, that the thinking is changing, we have better data. And so if you were told something years ago, it’s a good time to go back and see what has changed, and are there options.

Jean Sachs, MSS, MLSP (00:59:57):

I’m just going to ask one final question. I think this is what this person was getting at. Typically tamoxifen is prescribed for premenopausal women and AI is for postmenopausal. But what if you don’t do well on an AI and you are postmenopausal? Is tamoxifen ever an option?

Laila Agrawal, MD (01:00:14):

Yeah, it definitely is. And tamoxifen is commonly used in postmenopausal women as well. Tamoxifen has a small risk of uterine cancer, so if someone’s postmenopausal and has a uterus that is part of the counseling and decision making, but it’s absolutely a treatment option. And also aromatase inhibitors can be detrimental to bone density. Tamoxifen actually has a slight positive effect on bone density in postmenopausal women. So all of these different aspects are taken together. There’s a very low risk of blood clot as well. So when we’re picking the right medicine for the right person, it has to do with many different factors. And if we pick one, like an aromatase inhibitor, and then the side effects are really bad, we can switch to a different one and kind of rebalance that discussion again.

Jean Sachs, MSS, MLSP (01:01:02):

Yeah. So important to have a medical oncologist that you have a good relationship with and you can be very honest. Your patients are obviously very, very lucky. So I would encourage people if you feel like you can’t have this kind of conversation and get answers you need to get a second opinion or find other support.

Session 4 | Understanding clinical trials: How to find one and what to expect

Sara Horton, MD (00:10):

I am so honored to be here today. I’ve worked with and spoken to members of Living Beyond Breast Cancer before, and I love the type of breast cancer topics that you discuss. I was thinking about the topic you had last week on menopause and how important that is and how I’m going to go to your website and see this.

(00:30):

Thank you for asking me today to come to talk about clinical trials, specifically in breast cancer, which is near and dear to my heart. Like you mentioned, I work for a nonprofit right now that runs a couple of big adaptive platform trials. My role is just to make sure everyone has access to these trials and to help educate about another one of our nonprofit projects that we help support, which is breastcancertrials.org, which is a online free software trial matching program, which I’ll be going over later on in the talk to help you find. Anyone can go online and look for and find a trial.

(01:13):

Today I am just going to do a quick overview. Let me share my slides.

(01:16):

And just a little bit, quickly, about me. I’m based in Washington, D.C. I’m a medical oncologist for over 20 years. I’ve worked at a number of places, practicing mainly with breast cancer patients. I also worked at the FDA for a while reviewing breast cancer drugs. And now I work for clinical trials.

(01:37):

Alright, so today I’d like to talk about clinical trials. A little bit of background on how to understand what they are, and the important part is how to find them. My academic affiliation for the last, wow, 10 or so years has been with Howard University Cancer Center, where I’ve held a lot of roles, including the director of clinical clinical trials there. The agenda: I’ll go through many components of clinical trials, what to expect, the importance of diversity, becoming an advocate, and give a few sources at the end. And if time, I’ll go through an example of breast cancer trial work.

(02:21):

So what is a clinical trial? So a clinical trial is a research study. It involves people, and these are all volunteers. And the goal is to determine if a new product is, the mantra is, safe, if it works safely in humans, and if it works, if it’s effective. There can be a number of different types of treatment. It could be medicine, it could be a procedure, a device being tested, approaches to screening, like mammography or even a blood test like PSA, and even behavioral changes can be a treatment in looking at the way a disease is affected.

(03:01):

Why do clinical trials matter? Why are they important? Well, everything that you see on the shelves, anything that’s prescribed to you by your doctor has been rigorously tested through a clinical trial. So the things that are helping us and that we know work are only available because a clinical trial was done that included volunteers to help us identify these standard, best treatments.

(03:26):

When a drug or a device goes through a development stage, in most cases it goes in the U.S. through the FDA, and it goes through usually three, maybe four phases of clinical trials before it’s determined to be safe, effective, and OK for your doctor to prescribe.

(03:48):

Each phase is answering an important question in phase I studies, which are the first in-human studies, which are the smallest, it’s looking at safety. And so usually the patients may have all different types of cancers, if it’s a cancer phase I. But we’re looking at what’s the safest dose of this medication in a human.

(04:07):

When it’s found to be safe, it goes on to phase II, which is a little larger study. They know now that it’s safe. And in the phase one, they looked at the different type of tumors to figure out which one would be best to look at in phase II. Because in phase II, everybody has the same type of, for a cancer trial, cancer. And it’s looking at how well this drug works against that cancer. How effective is it?

(04:32):

After a phase II study, if it looks like the drug could be as good or as effective or better than our best treatment are much larger, much longer studies. And that’s the study that the FDA usually looks at to determine whether it’s a drug that can be approved and, again, be out in the community and prescribed. And it’s being compared to our best, our standard of care. Usually it’s randomized meaning that a patient, if they decide to enroll, is randomly selected to go one into one arm or another based on statistics.

(05:14):

So those are the main three phases that all drugs go through. At times the drugm may be asked to have a phase IV study, which is after the drug is out in the community, it’s being prescribed, it’s been approved, to see if there are any long-term effects that we need to be concerned with.

(05:35):

So those are the four phases of clinical trials.

(05:37):

In breast cancer, just to very generally divide up the way we bunch our clinical trials, there are early-stage trials, meaning there are clinical trials that are being performed on patients who have breast cancer stage 0, which is ductal carcinoma in situ, through stage III. All of these are scenarios where the cancer has been treated usually involving some type of surgery and there’s a systemic or chemotherapy given before or after.

(06:11):

And the clinical trials are trying to optimize to try to improve what we have already to see if we can be more personalized with our treatments. Some women we know may not need as much as we’re giving, all stage III patients kind of get the same treatment right now, but we’re learning to find ways of doing research to find are there women we can deescalate a little bit. Or maybe there’s some women, a group we find, that don’t do as well with the treatment, they have a higher risk of recurrence, should we escalate the treatment.

(06:41):

So that’s all in the process right now of different studies. We look at survivorship after treatment, especially in early stage, to see if there are things that can be done to prevent recurrences.

(06:52):

And then we have the metastatic or stage IV setting where a lot of the focus of the treatments are on newer, innovative drugs to try to improve what we have because the more drugs we have in our arsenal to use, the longer we can keep people alive and functioning and good quality of life. And we’re looking at biomarkers and targets and you’ll hear a lot of that terminology if you’re in clinical research.

(07:19):

In terms of the type of trials that there are, I’ve been talking a lot about treatment trials, when there’s an intervention and the patient actually gets something, a drug or something happens. But there are screening trials like mammography or different ways to detect a disease or a cancer before it occurs. Prevention trials. Are there things we can give or do to help prevent a disease from occurring? Quality of life studies. They can be on their own or they can be along with a treatment trial to look at how the treatment works in patients to see if the toxicities or the side effects are worse than what we have already. Because not only do we want safe and effective, but we want drugs that aren’t going to give a lot of toxicities to patients as well. Very important because that affects survivorship.

(08:14):

Now, a lot of people have questions about clinical trials. Some people just shy away because there is too much of an unknown. And hopefully by the end of this presentation you’ll feel a little bit more comfortable thinking about clinical research. But these are some general pros and cons that we’ve found in research that people consider. So I’m just going to go through them on my own with pros first.

(08:43):

We said potential for better, safer treatment. This one is also, actually a pro. You have an increased number of treatment options available, especially in some settings where there are few treatment options. Clinical trials offer the potential for better and more. Again, we talked about this, the coverage of the cost for care. This also is a pro. Closer monitoring by your cancer care team. When you’re on a clinical trial, just by the nature of the study, they’re going to be seeing you more often, maybe doing a few more tests, keeping an eye on the cancer a little more tightly while you’re on treatment.

(09:21):

And these are the cons. We have uncertain side effects in the investigational treatment. The treatment may not work as well as we expect, that could be a con. If you’re randomized, you may not get the arm that you want. You may go in there thinking you’d like the experimental drug. And some are blinded, meaning that either you may not know the drug that you’re getting and sometimes it’s double-blinded where your physician, the principal investigator, will not know the drug that you’re getting either until the very end. And some people aren’t comfortable with that.

(09:57):

But no matter what the outcome, if you decide to participate in a clinical trial, it allows you to be active in taking a role in, not your own care, but helping to determine our future therapies.

(10:13):

How do you find a clinical trial? So there’s a couple of ways. These first two are sites online where you as a patient or your provider or anyone can go to look up U.S.-based clinical trials. I’ll talk a little bit about them in just a minute. But if you’re diagnosed with cancer, you’re being treated for anything, but I’ll focus on breast cancer right now. The first thing you should do is ask your oncologist, and you can ask your medical oncologist, your radiation oncologist, your surgical oncologist, anyone who is on your team. You can ask the patient navigator if you haven’t heard about clinical research from your provider.

(10:59):

And then separately, what I found recently, and this is an example of your patient portal, is that in some of the mobile patient portals, say for instance, this is Epic, you can go in and you can find a tab called “research studies” that you can click on.

(11:19):

So those are different ways that you can look into what’s being done where you’re being taken care of. If your oncologist doesn’t mention clinical research to you, make sure you ask. Lots of reasons that a provider may not mention clinical research, and I’ll go over that in a bit. But for whatever that reason, empower yourself by saying, “Is there a clinical trial that you think that would be appropriate for me?” And hopefully that will trigger that provider to make sure they give that information the next time.

Jean Sachs, MSS, MLSP (11:54):

Dr. Horton, I’m going to ask you a quick question, if that’s OK, because I think that we hear this a lot at Living Beyond Breast Cancer. Do you suggest that when you’re newly diagnosed, whether it’s early stage or metastatic, that is the time to ask about a trial? If you could give any guidance around that.

Sara Horton, MD (12:16):

Yeah, so I’m glad you asked because I say earlier in every case. Because one of the things that a lot of people don’t know is that there are clinical trials for just about every stage of not only breast cancer, but any disease. And so I think it’s important to ask your provider if they think that you would be appropriate for a trial from the minute you’re diagnosed. And then at every stage, be it even survivorship. If you’re following up for your follow-up visit, everything looks good. Maybe there’s a new study where they’re testing exercise or nutritional differences or meditation in survivors to see if that impacts your outcome. And these kind of trials are also all listed in clinicaltrials.gov and breastcancertrials.org, so you can go and search for those trials yourselves at any point, even if you’re not in the doctor’s office. So hopefully that answered the question.

Jean Sachs, MSS, MLSP (13:23):

Yes, thank you.

Sara Horton, MD (13:24):

OK. And one other thing I wanted to mention is a lot of people have heard that clinical trials are only for patients who don’t have any other options for treatment. Either you’ve been through everything or you’re metastatic or it’s someone who can’t tolerate any other treatment, but that’s not necessarily the case. Think of them sooner rather than later. Think of them in any scenario.

(13:50):

If you are at a community cancer center or any cancer center that does not run clinical trials, you might want to look at academic centers or universities in your area. Just give them a call, find out if they have any studies or if they’re aware of places that have clinical trials. Not all trials are done at all sites, and that’s the unfortunate part and why being able to go onto either breastcancertrials.org or clinicaltrials.gov is helpful because they will list all the sites that are doing that specific study.

(14:25):

And different sites do different studies, so just don’t check one, try to find out the different places in your area that are doing clinical research. It may mean that you have to go to a place other than where you’re getting your care for that study, but usually they keep in touch with your oncologist and send information back in their communication. Another way of finding clinical research, especially if you’re in a rural area or areas that have a lot of community cancer centers is NCI has something called NCORP, N-C-O-R-P, which is their NCI Community Oncology Research Program where they band together a bunch of community centers and they do the administration for clinical trials for these sites. So thse are places that you can always check.

(15:18):

And then of course, these wonderful advocacy groups and nonprofits like Living Beyond Breast Cancer, American Cancer Society, Komen, I work with Tiger Lily and Sisters Network and SHARE. And so there’s lots of organizations that you can contact that may be able to help direct you to places that can tell you about clinical trials. So lots of ways to find them.

(15:46):

This is breastcancertrials.org, which is specifically breast cancer trials. Now I’m going to go back very quickly to clinicaltrials.gov is on NIH’s website, and it is a database full of all the clinical trials that are registered through the FDA in the United States. So not just cancer, could be diabetes, cardiovascular, whatever, any clinical trial is listed at clinicaltrials.gov. It’s comprehensive, but it’s also a bit clunky and can be difficult to get through if you don’t have a medical background or a technology background. So it’s a wonderful thing to have. It’s not the easiest to use.

(16:33):

And because of that, breastcancertrials.org was started back in the late nineties at UCSF by a woman who was a researcher at UCSF, who was diagnosed with breast cancer and discovered she had to go all over the place to try to find these trials. And she partnered with UCSF to develop this online software program, which was actually launched, I think in 2008 or 2009. So it’s been available for almost 20 years, a long time.

(17:04):

It’s a wonderful resource if you’re interested in finding a clinical trial. And I can at the end go through very quickly a demonstration. But this is kind of what breastcancertrials.org has to offer. It has a trial search one that we call breast cancer trial search that’s focused on stages 0 to III clinical trials. And they have clinical trials on actual treatment, on quality of life trials, on survivorship after you’re done with treatment. Are there clinical trials? Some you don’t even have to leave your home for.

(17:39):

There is a separate search for metastatic breast cancer. After a couple of years of launching breastcancertrials.org, the advocates for metastatic breast cancer specifically said they want something that was for them. And so this is a really comprehensive trial search for stage IV disease on all different levels. And along with that is “Metastatic Trial Talk,” which is a monthly newsletter that’s put out with some of the newest innovative technology as well as just really great information for anyone who has metastatic breast cancer.

(18:19):

And the newest addition to breastcancertrials.org, which I’m really excited about, is about a year ago we brought on a clinical trial navigator. So she’s a nurse breast oncologist navigator, certified navigator, who also is a survivor, who is available for anyone to make a candidly appointment. There’s a tab on the website where you can make an appointment if you’re not comfortable putting your information and trying to find a trial yourself. You can save the information, come back to it, and she also does open hours. I forgot what she called it, but she has times where she’ll just kind of post some hours where she’s available to answer questions so people can hear what other people are asking, which is, I think, an amazing opportunity.

(19:08):

This is the webpage for breastcancertrials.org. You just click on this box if you want to do it. It’ll start you on your search for stage 0 to 3. And if you’re looking for metastatic trials, you click on this box. And if you’ve got time, you can watch, there is a little tutorial. This is a QRS. I’ll show this at the end of the presentation, but we’re moving on to barriers to clinical trials.

(19:34):

What we hear often is reasons why people can’t or won’t or try and it doesn’t work, being on a trial, is because of geography. It’s either this study is not available near them, it’s too far to go, there’s a lot of visits you have to make, takes time off work. That’s money, travel costs money, caregiving for your kids or for adults.

(19:58):

The cost, most of the time, and we really encourage this, there is a financial review for the patient before they go onto the trial so you’ll have an idea what out of pocket costs would be. And insurance now covers the cost of standard of care. Anything that is not the standard of care, the sponsor will pay for, you’re not responsible.

(20:26):

Sometimes it’s a language barrier, be it actual a different language speakingm, and so we have a lot of translation of our documents and scientists are really starting to try to make sure they have navigators who speak a second language.And health literacy barriers and just not understanding the lingo of what’s involved in the clinical trial. And so we have a lot of educational materials. We have navigators being trained to help people really make informed consents.

(20:55):

Again, we said the trial may not be available. There is always the trust issue, as I’ll call it. There’s been historically distrust of medical research for a lot of very, very good reasons. I won’t go into them all. Some of you are familiar about some of the unethical studies that were done in the past. There are a lot of patient protections in place now to make sure that never happens again. Making sure patients are informed, understand what’s involved in the study, what’s being done with all of the data that’s being collected and how it’s going to be used.

(21:34):

And then there’s the eligibility criteria. Every study has a list of requirements of the patient, which we call eligibility criteria, to make sure it’s safe for them to be in the study. And sometimes it means you can’t have any type of kidney disease or heart disease that some people may have had, and it may exclude them. So it’s important to go through all of the criteria of the trial.

(21:58):

And a big barrier we’re finding, unfortunately these days, is that patients are not being asked by their doctors about clinical research. It’s never mentioned. They don’t know to mention it. And so it’s not even in the discussion. Hoping this will help to empower you to know that it should be in the conversation and if it’s not to bring it up.

(22:21):

Overcoming these barriers. So in terms of the financial responsibilities, of course, request financial navigation early. Ask them if they don’t s talk to you about the cost of being in the trial. In terms of the language barriers, interpreters, a lot of sites have them, ask for them if they don’t have them. Ask for translated materials. Bring someone with you if possible. Two sets of ears are always better than one, I always say. Sometimes I know if I had someone who’s coming alone, I would ask them to call someone who they felt comfortable with, if you wanted to do that, just to listen while they’re getting this information.

(23:04):

Discuss the schedule of visits. It’s important to know what’s going to be expected of you time-wise on a study. And so you can ask to see the schedule of visits. Ask if there are remote monitoring possibilities. Some studies have them. If for some reason, you’re not found to be a candidate for a study, you’re really excited about that drug, ask about expanded access, meaning that the principal investigator can make a request from the FDA specifically for you to receive this drug outside of the trial. And it would be monitored as well. And it’s not always granted, but it can be granted and the pharmaceutical company usually provides it free of charge as well.

(23:51):

And then again, we talked about the NCI Community Oncology Research Program if you can’t find a program near you.

(24:00):

So you’ve decided that you’re going to be in a study. So what is going to be expected of you? And what should you expect? More than that, what should you want from this?

(24:12):

Hopefully the language in the informed consent is something that you understand. We’ve been working, those of us who work in clinical trials have been working with advocates to review all of the informed consents to make sure that a patient would find this acceptable. Because it needs to explain everything in a way that the patients should understand.

(24:37):

You can ask questions and take your time. Don’t ever feel rushed if you’re considering a clinical trial. If you are, you can tell them, “Look, I need my time.” There are some that have time intervals from the time of, say, your diagnosis or your last MRI, but you ask about that. Take the time, bring the papers home, mull over it, have someone you know or respect read it with you.

(25:01):

And you can withdraw at any point of being in a trial. Even if you’re just going through the screening or you could have started and you’re on your third dose, you can withdraw at any time.

(25:13):

All clinical trials are overseen by independent review boards. So there’s an IRB, which is an institutional review board, which reviews all of the material that comes through from the study to make sure that it’s safe. And they’re not associated with the trial at all. So that gives you kind of unbiased scientific eyes on the study to make sure it’s ethical, it’s safe. And then during the study, every study has what we call a safety board, a safety monitoring board, that they have to put together, the study has to put together, of, again, experts in the field that are not associated with the study, who periodically, be it quarterly, look at the data that’s coming out of that study and make sure that there’s no red flags, there’s no safety issues that need to be addressed.

(26:05):

And during the study, the clinical trial is required to note and gather and keep track of all the toxicities, we call toxic events or toxicities or we call them adverse events, that happen with the study. And those are all sent into the FDA. That’s one of the things I did as a medical reviewer is I would receive the adverse event forms from a study. And we keep an eye on it throughout the entire study so that if we saw anything that was a red flag or didn’t look right or too many people are having lung problems on this, we then can contact the sponsor and a range of things up to stopping the trial if it’s serious enough, until it’s identified and fixed.

(26:52):

In terms of costs and coverage basics, in general, anything that’s experimental or research or related to the research study drugs or tests that are done only for the trial are covered by the sponsor. You are not, as a patient or participant, responsible for those costs. If it’s standard of care or routine care that you would’ve gotten off study, then those are covered through your insurance. So there may be a deductible with those. And again, that could be worked out before you enter a study, but it would be the same that you would be paying if you were off the study. Again, we want you to ask for what’s called a coverage analysis if you’re interested in a study to find out what those costs are. And there are some out-of-pocket costs that are indirectly related to being in a clinical trial, maybe travel or parking or time off of work, that there really is no built in way of supporting those costs. We’re working on it in research, trying to get policy change to help support it. Some trials have built it in, some haven’t. It’s something you’ve got to to ask about. But there are a lot of nonprofits out in the community that are starting to put together resource funding for patients, not only who are just dealing with cancer treatment, but also on clinical trial.

Jean Sachs, MSS, MLSP (28:24):

Dr. Horton. Can I just add one thing and you can take a breath?

(28:27):

I think that issue is so important of those out-of-pocket costs. And I will say this is a way that patient advocates can get involved, and we have involved patient advocates in the study design phase. And sometimes those expenses can be built in as part of the costs that are covered, because it takes a real toll if you have to travel or spend the night or miss work. So for everybody watching just know this is a way you can get involved as an advocate, because everybody wants more participation in the trials, so there’s a real incentive. So thank you for bringing that up.

Sara Horton, MD (29:07):

Absolutely. And thank you for mentioning that because, as you said, it’s not standard for that to happen. But more and more we’re seeing that the sponsors and pharmaceutical companies and people who run trials are starting to open up and understand that this is a necessity if we’re going to be able to be inclusive of all people in trials to be able to support some of these extra costs that are brought on by being on the trial.

(29:33):

How to talk to your provider. Again, if you’re interested in clinical research, just share your goals, the reasons why you’re interested, with your provider. Make sure that it aligns with the trial, so as you identify trials, you can specifically bring them to your provider to see what their thoughts are on it.

(29:57):

There’s something called an NCT or the National Clinical Trial ID number that every single clinical trial has. I’ll find a picture of one. But all you need is that number to be able to put that into clinicaltrial.gov, and it will bring up all the information on that trial. And your doctor can find it as well. So it’s a nice ID to know if you’re considering a trial. Clarify all the logistics. Again, the schedule of visits, how often you have to be there. Have a backup plan, and ask how and what the results are and how they’re going to be shared with you and with anyone else. That’s very important. The ROR we call it, the return of results.

(30:41):

Diversity in clinical trial. I speak on this a lot for a lot of reasons. It’s always been a passion to me because of the health disparities that we have, especially in breast cancer, where we see certain populations don’t do as well for many, many reasons when they’re diagnosed with breast cancer. But one of them it, I feel importantly, is that it’s because some populations are not represented in clinical research. So we just don’t know what may be happening, be it genetic level, with these patients so that their outcomes are disparate.

(31:19):

We think that having a good representation of patients, especially those that reflect not only the U.S. population but those who are affected by the disease, is important to have in the clinical trial makeup of patients. And so it ensures that the drugs that are being looked at and approved are effective for everyone. It reduces the disparities. It builds trust. I think when someone has gone through a clinical trial, most of the time I’ve heard nothing but good experiences. Not all the time, but I think that helps to engender more trust in people who are interested. We’re including community sites, making it easier language wise with different communities that need the information in their language.

(32:09):

We’re looking at flexible times, having sites open later in the day and on the weekends so people don’t have to miss work. And so patient feedback helps us in helping to design more not only accessible but welcoming trials. Examples of what are considered underrepresented populations in clinical research are ethnic and racial minorities like Blacks, Hispanics, and Native Americans. Social, economically disadvantaged and low income patients, those in the rural or remote areas, sexual and gender minorities, it’s just LGBTQ hasn’t been specifically studied. Older patients, as we age much longer, we’re needing to know how drugs work in older bodies. Younger patients, pediatric patients are starting to really get better eligibility criteria. And even the young adult population, especially in cancer, because we’re seeing the one group that’s having an increase in incidence of cancer are younger people, below the age of 50. So we really need to make sure we’re including them in our trials.

(33:23):

So Jean talked a little bit about being an advocate, which is so important. And if you’re an advocate, how you can be involved in the clinical research spectrum. So you can join patient advisory boards. The FDA, when I was there, they have an open panel of anyone who’s interested that you could get on so that you can be asked to be part of the discussions that they have. Most studies have protocol review groups that like to involve advocates.

(33:54):

I work with a neoadjuvant study called I-SPY that is a huge adaptive platform study, and we have 30 working groups. Every working group has an advocate on it, and that’s the way it should be from the development of choosing the agents to the informed consent to our return of results, it involves input from patient advocates. They give feedback on everything, and it’s so valuable, valuable not only to us, but I think to other patients to come.

(34:26):

This is just a resource list that I’m just going to have here, and it’ll be available online where you can learn about clinical trials and informed consent. And this is the community oncology research program. These are some resource groups. I put Lazarex in red because they’re an amazing cancer foundation that provided all kinds of support, funding, and resources to patients. And I just went to their website and found that December 25th is going to be the last month they’ll be open, and they’ll be closing. And the founder is just an amazing story. So if you have time to go to her website, please look at it. And American Cancer Society, Triage Cancer, and some co-pay relief support.

(35:13):

So that was it. I want to thank you for letting me discuss a really important issue, and I hope it’s been helpful.

Jean Sachs, MSS, MLSP (35:22):

Dr. Horton, this has been great. And I know we might do a demo of one of the trial searches, but I do have a bunch of questions, so maybe we could take some of them on. And I just really appreciate how much you shared all the thought and safety and innovation and changes that have happened with clinical trials because I think there are so many myths about them, and you did a great job of building that in.

(35:51):

So I’m just going to start with the questions. One is, there’s a couple of people that are asking about are there age restrictions? We have women with breast cancer who are 65 or 70. Talk about that.

Sara Horton, MD (36:06):

Yes. There tend to be age restrictions, but we have been in a spectrum of, I say loosening and I hesitate when I say loosening them up because people see that as a negative. But it’s actually in a safe way. We’re loosening the strict eligibility criteria that has historically been there so that we are starting to include higher ages.

(36:33):

There’s not a standard cutoff age now for all trials. And so what you need to do is look at the studies, and you’ll see that people are getting more comfortable with a higher age, and younger age as well. They try to make it reflect the disease as well. If we’re seeing more younger, like triple-negative breast cancer, studies hopefully will have a little bit younger age where you start to enroll them. But most of the time it’s 18 and up. And I can’t think off the top of my head, but I know we’ve had patients definitely in their seventies and some in their eighties.

Jean Sachs, MSS, MLSP (37:11):

OK. That’s good to know. And I think this is a good question also. If you decide to join a clinical trial, are you still able to see your regular medical oncologist?

Sara Horton, MD (37:23):

Absolutely. That’s your relationship with that oncologist. You can see them as much as you’d like. The only thing is that they have to be aware that you’re on a study and there are some restrictions about medications you can take. So anytime someone sees their doctor, we like to, say I’m running a study, I like to not only send my notes to them so they know what’s going on, but understand that if anything is given new that could impact the drug that’s being given to them, or if a procedure is done that that needs to be told and hopefully not done until it’s OK with the study.

Jean Sachs, MSS, MLSP (38:09):

Right. OK. That’s helpful.

(38:10):

This, I know, has to do with the trial design, but a few people are asking. Is it true that only half the people that are in a clinical trial get the novel treatment or are getting a placebo? How do you know what’s happening?

Sara Horton, MD (38:27):

OK, well, I will tell you that ... let’s see, where do I start on this one? So it’s not necessarily the case that half the people will get the experimental drug and half will get the standard of care. So that’s the kind of the basic makeup of the phase III study. The randomized clinical trial. For example, if you’re in a phase II study, right? So they know it’s safe, and now they’re looking at how it works, how effective it is. Everybody gets that drug. And, for me, again, I work with a neoadjuvant phase II large study that has four arms, and everybody gets one of the novel drugs.

(39:16):

And you have to, if there’s a study you’re interested in, that’s why it’s important to go through it with the doctor so you understand what type of study. Is everybody getting the experimental drug? If they’re not, how are they dividing it up? And if it’s divided up, what are other people going to be getting? And when we talk about placebo, or the sugar pill, as some people call it, it’s very rare that you’re going to find that in a cancer clinical trial. The only place where a placebo, meaning something that doesn’t include an actual medicine is given, is if the standard of care is nothing. Right? So maybe it’s a clinical trial for metastatic pancreatic cancer for patients who have got gone through two lines already. And so right now, if you’ll look at our cancer guidelines after two lines of treatment, there’s, there’s not any specific treatment recommended. And so some people go on to what’s called supportive care. Well, some clinical trials want to say, well, maybe there’s something that can continue to work after that second line. So here’s the study. You’ll either get the new drug or best supportive care, which is usually not a medication, but everything else to make sure that you’re feeling OK, if that makes sense.

Jean Sachs, MSS, MLSP (40:43):

Yeah, that’s helpful. And all this information has to be disclosed to the patient, what the trial design and if you’re blinded, but some are unblinded.

(40:55):

I believe this question is probably coming from someone who’s living with metastatic breast cancer and saying: If their current treatment is working, why would they consider going into a trial?

Sara Horton, MD (41:09):

So if your current treatment is working, I would not go into a clinical trial. I would keep it ... unless it’s a clinical trial that doesn’t interfere with your treatment. There could be like a supportive trial, like I love the use of yoga or acupuncture. We did a restorative yoga treatment in metastatic breast cancer patients when I was at Howard. Those type of things don’t interfere with the treatment, but it may help you get through the treatment, it may help you long term and helping the treatment work longer.

(41:47):

So it depends on the type of study, but if you’re talking about another treatment study, I would wait. A lot of times in metastatic disease, the doctor is thinking down the line, we’re going to stay on this until it doesn’t work, but be ready with potential options when it doesn’t work, which may be a study.

Jean Sachs, MSS, MLSP (42:11):

OK. That’s great advice. We always help metastatic patients to always be thinking ahead in case your treatment does stop working. And checking out what trials are out there and having those conversations, are you eligible. So that’s great.

(42:30):

I’m not totally understanding this question, but I think I can phrase it in a way that you can answer it. So the question is, is it best to go through each stage of the trial. I know you talked about the different phases, but can you just go through that so people understand how different each one is and that you can enter at various phases?

Sara Horton, MD (42:53):

Yes. Thank you.

(42:54):

Yeah, that slide can be a bit confusing. It doesn’t mean you start on phase I and go through all the phases with the study. But what it shows is that there are different phases that every drug has to have. Like a phase I trial, and then once that’s done, then they go onto the phase II. So for me as a patient, it depends on where you are in the disease process, but most people look for either either a phase II or a phase III study. And I say that and I hesitate because phase I studies are very, very important too, but most doctors will know if you are someone who would benefit from a being in a phase I study. So that’s part of the conversation that you really need to have with your provider. That could be one of your first questions: “Do you think that I’d be a good candidate for a clinical trial?” And if they say yes, you can say, “Well, which phase would you think would be good for me?” And so they can guide you.

Jean Sachs, MSS, MLSP (44:10):

Right. That’s helpful. I have to say, I’m looking at the chat, there’s a lot of participants who are on trials and have been on more than one. So thank you, everyone, for, as you said, you are volunteers. And that’s true. You’re volunteering to help, hopefully yourself, but also everyone who’s coming up.

(44:30):

I’m sad to even ask this question. But do you have any insights on how federal cuts might be impacting clinical trials, particularly those in breast cancer?

Sara Horton, MD (44:43):

Yeah, so we’re all just kind of bracing ourselves for what’s happening. One of the things that is a little protective almost of clinical research is that a lot of it’s done by pharmaceutical companies, not necessarily tied to the federal government. I mean, way back when I was training, you know, 20 some years ago, most of the clinical trials were supported by the government, by NIH and DOD, and we had cooperative groups that were all part of government funding. So any time something happened with funding, it really, really could stop the amount of research that’s being done. Because pharmaceutical companies are independent, I don’t think that research is going to stop, but it may be changed based on what the administration feels is important.

(45:40):

So we’re all kind of just trying to dig in and keep moving forward. Right now, the cuts to Medicare and Medicaid may impact clinical trials, we don’t know yet. I think in 2023, they passed a clinical trial act that required Medicaid to cover the cost of a patient on a clinical trial where they hadn’t before. Not sure if that’s going to go away. So, so far not done, but we’re just waiting to hear.

Jean Sachs, MSS, MLSP (46:10):

That’s helpful. Thank you. I know that comes up in every single program we have done this year, so hopefully we’ll get moved beyond that.

(46:18):

One thing that I’ve been asked several times by people that are considering trials is they want to know, do the medical oncologists benefit financially if they enroll people?

Sara Horton, MD (46:32):

OK, a quick, “No.” <laugh> A quick, “No.”

(46:39):

I want to be totally transparent in that there are some organizations that are starting that I’ve seen, I have just heard about, where they help support a patient being on trial. If a provider identifies that they’re a candidate and they can’t like travel there, then they can contact this organization. They can set up the trial, and I think they give the provider some type of resources or funding. I’m not sure. So it’s nothing that happens a lot. I just don’t want to say it never ever happens, but that is not the status quo. Anywhere else, docs do not get paid for putting people on trials, and pharma doesn’t. I hate to even put that in there because it’s such a fringe thing that I’ve heard of. But no, there’s no money that the institution gets from putting people on study. They get paid to cover the cost of whatever the nurse has to infuse, whatever they would be charging, to insurance if it were off study is what they charge.

(48:03):

And that’s why a lot of places don’t do clinical research. It’s not lucrative, you don’t make money off in clinical research. So a lot of institutions see it as a losing money policy.

Jean Sachs, MSS, MLSP (48:19):

Yeah. That’s good to know because I think sometimes you’re so vulnerable when you’re diagnosed with breast cancer, any disease, and if a doctor is encouraging something, I think those questions come up.

(48:31):

If it’s OK with you and you want to flip back and Dr. Horton will do just a quick demo of one of the clinical trial searches, so it feels less intimidating. If it works, just do it.

Sara Horton, MD (48:44):

OK, let me pull it up.

(48:47):

And I did want to mention when someone asked about the impact of the cuts in research. I don’t want to minimize the damage that’s been done by the loss of the researchers at NIH and NCI. It’s devastating in that these are are great researchers who have been just kind of stopped. But luckily, honestly, a lot are going to different places. They’re going to some of the pharmaceutical industries to continue the good work. So hopefully things will change and they’ll get back to the way it was.

Jean Sachs, MSS, MLSP (49:20):

Thank you for saying that.

Sara Horton, MD (49:22):

Sure. OK, let me pull this up. There we go. All right.

Jean Sachs, MSS, MLSP (49:27):

We don’t have it yet.

Sara Horton, MD (49:30):

OK. Tell me.

Jean Sachs, MSS, MLSP (49:32):

Looks like, yes, we have it now.

Sara Horton, MD (49:36):

OK, let me move this off. All right, so what I was going to do is a quick demonstration of how to find clinical trial, metastatic breast cancer clinical trial using clinicaltrials.gov.

(49:49):

So this is I believe this is a landing page, the first page you come to, but what I’m going to do is just click on this metastatic trial search. You can either just continue as a guest without putting your information in, or you can register and it can save your information for when you come back. None of your information is used, sold, given to anyone at all. That’s one of the things I love about this site. So I’m a guest, and it’ll answer questions, it’ll match you up, and then you can register at the end if you want to. So it says it’s going to open a new tab.

(50:29):

The first is a set of questions that they’re going to talk about for you to answer on your breast cancer biomarkers. At any point, these may be questions you don’t know the answer to. You can always say unsure. Most of these answers are found on your pathology report. Or you can always make a list of things and ask your doctor.

(50:56):

So, say I had estrogen receptor, I know it was positive, my progesterone was positive, my HER2, they ask for low now, you may or may not know that because some trials are being done with the low levels of these. I’ll say it was HER2 negative. Some people know if they’re BRCA 1 or 2. I was negative. Androgen receptor. I’m not sure. PD-L1, I’ll say positive. That’s a biomarker. If you’re not familiar with it, again, it would be on your pathology report or you can ask your doctor. PIK3CA, I don’t know. I don’t know if they’ve tested me for it. Next.

(51:35):

Has your tumor been described as ...? So the histology, you may know if it’s ductal, lobular, inflammatory, metaplastic. Most breast cancers are ductal, maybe lobular, but mine was ductal.

(51:47):

Where do you currently have evidence of disease? So that’s the metastatic part. You may or may not know all the areas. It doesn’t matter. You just put it in what, you know, select all that apply. May have bone metastases. I don’t know what leptomeningeal is. These are the innermost layers of the tissue that cover your brain. So they may have told you if you know you’ve had any brain involvement if it’s leptomeningeal or not. And then abdominal linings is your peritoneum or your omentum. You’ll hear these terms in cancer, but I’ll just say to my lung, I know that, and to my bone.

(52:33):

What was the date of your metastatic diagnosis? So honestly, the date and year, if you remember, you can make it up, it doesn’t matter. But what I’ll say is January 25.

(52:45):

And the more information you put in, the more it can better find trials. And it’s OK not to answer them if you don’t want to. Pre- or postmenopausal, if you’re perimenopausal, I say just put pre, as long as you’re having some periods. Otherwise if you know you are past menopausal, postmenopausal. Birth year, my zip code, Black or African American, and you can click as many as you want for your race. Latino or Hispanic, no. Highest level of education, postgrad. And that’s all demographic information that’s helpful to breastcancertrials.org.

(53:32):

Yeah, this information is very helpful.

(53:36):

So it took a minute and I love this. What it does is it tells you you have 279 trials. This is my profile I put in, and then it shows you a map of the United States. So you get an idea of where they are, all over the place. I’m in D.C. area. So you can filter by several different ways. You can always just start going down through the trials. I’ll just give you a quick snapshot.

(54:07):

All of these trials are trials that are from clinicaltrials.gov. So breastcancertrials.org contains all of the breast cancer trials that are in clinicaltrials.gov. But they curate them and they repost them in a way that it’s easy for you to understand and find.

(54:23):

It does, if you decide you’re interested in it, you’ll click and it’ll take you to clinicaltrials.gov that has the whole exhaustive list of everything about that trial.

(54:34):

But it tells me this study right here, sacituzumab, is for HER2 positive ... I mean HR is hormone receptor, ER or PR, positive, HER2-negative breast cancer. That’s what I had. It’s Holy Cross, it is right up the street from me. And here’s that NCT ID number I was talking about. Jot that down, that helps you find it in clinicaltrials.gov. And it’s a phase III trial, gives a short synopsis to tell what it’s about and who it’s for. It’s for advanced, so it’s some stage III or stage IV. So that includes me. ER positive, HER2 negative, and who received hormonal therapy with a CDK 4 inhibitor for advanced disease.

(55:20):

So it’ll be important for you to know what you’ve had before. For this trial, I will have needed to have had a CDK 4/6, like ribociclib or abemaciclib or one of those, and you must not have received chemotherapy. So these are, you could have hormone therapy, like the aromatase inhibitors, or tamoxifen or exemestane. You can have had that. You can have had one of the CDK 4/6 inhibitors, but no chemotherapy for metastatic disease, or advanced disease. You could have had if you were treated with, say, AC and Taxol for any adjuvant setting.

(56:05):

So I’m like, OK, maybe this is something I’m interested in. You can look at the full eligibility criteria. This takes you to clinicaltrials.gov. I’ll go to the top. Clinicaltrials.gov, and this is their whole official study overview and all of the information that you’ll need for the study.

(56:25):

It lists all of the sites too. So you can find, like if I wanted to look for Maryland, it’s in Baltimore, it’s in Silver Spring, Maryland. That’s the one close to me. And I can look in Washington, D.C. They’re all listed here.

(56:47):

I’m going to go back because that took me to the eligibility criteria. And that has all of the inclusion and exclusion criteria that you can delve into a little bit deeper here. It’s 18 years and older. I don’t even know if they have an upper cutoff for age. I’ll have to start looking into that. If they’re just open-ended now. And then clinicaltrials.gov along with breastcancertrials.org, I didn’t go further in, but it will list what the protocol is, which is your experimental arm, A, which is the drug, and then pembrolizumab plus the sacituzumab is the other arm. And then treatment of physician’s choice is usually your standard of care. So this gives us what the trial is about. I’m going to go back to clinicaltrials.gov.

(57:40):

I can filter this by saying I only want trials that are within 50 miles of where I live and of my zip code. And you can say if you want phase I, II, or III. I leave it open, and apply the filter. OK.

(57:55):

And then the last thing is here, if you put your information in and log in, you can get set up for trial alerts. Where they will send you a ping email anytime a new trial opens up that matches up to what you’ve put in as your criteria. So let me stop sharing.

Jean Sachs, MSS, MLSP (58:14):

Yeah, you did a great job. I think you can see that when you’re using the breast cancer clinical trial search, it’s so much easier. Then once you get onto clinicaltrials.gov, it gets more confusing.

(58:25):

There’s someone who made a really good comment that often public librarians or university librarians can help you with this. Obviously your healthcare providers. There’s a lot of other resources because it can get pretty detailed. And I think you saw they give the chemical name of the drug and then they give the brand name. I know that can also be really confusing to patients. But I really appreciate that demo because I think it kind of reduces the intimidation. You don’t have to log in, you can just play around with it. Or you can have a friend play around with it and then go in.

(59:04):

I’m really ... this was a fantastic presentation. There were so many positive comments in the chat and gratefulness for you. And so I want to thank you so much.