Publications
Insight, Winter 2005
In our winter 2005 issue of Insight, we help you understand clinical trials, share the story of one young woman's experience of breast cancer and explore the celebration of milestones during and after treatment.
Table of Contents
Making Sense of Clinical Trials: What They Mean for You During and After Treatment
Before your breast cancer diagnosis, you may not have thought much about clinical trials—or even known what they were. Maybe you believed clinical trials were for "guinea pigs" or people without options. Your doctor may not have discussed them with you. Or maybe you felt you had little time to think about them before making a treatment decision.
The truth is, women who participate in clinical trials are pioneers. All our progress in cancer research is because of people who tried the latest, most novel treatments, tests or procedures with the hope of improving outcomes for themselves, family members and generations to follow.
Choosing to participate in a clinical trial is a serious decision. Understanding how they work can help you weigh your options so you can speak more confidently with your healthcare provider.
What Is a Clinical Trial?
A clinical trial is any research study that tests how well new medical approaches, medicines or treatments work in people and determines their safety and efficacy.
Private companies and government organizations sponsor clinical trials to find out whether there are better ways to prevent, diagnose or treat disease. These new therapies or combinations of therapies may have better outcomes than the current standard treatment. Another possible benefit is that the new medication or procedure may be as effective as the standard but may have fewer side effects. Types of clinical trials include:
• Preventive clinical trials for women at high risk for developing breast cancer help find medications, vaccines, treatments or lifestyle methods that may help prevent disease.
• Screening trials for women who have not yet developed breast cancer look for ways to detect cancer at the earliest stage possible.
• Treatment clinical trials evaluate and test whether a new medication, vaccine or procedure or a new way of using an existing treatment is more effective than the current standard. Treatment trials are available for all types of breast cancer—invasive, non-invasive (DCIS and LCIS), advanced (metastatic), inflammatory and others—and may include chemotherapy, hormonal therapy, vaccine therapy or surgical/radiological procedures.
• Supportive trials help people in treatment deal with the symptoms or side effects commonly associated with breast cancer.
• Quality-of-life (QOL) trials gather information on activities of daily living, side effects and how the person is feeling during and after treatments with the goal of making future improvements.
• Survivorship studies evaluate and study how treatment may have impacted or changed a person’s viewpoints on health-related issues with the goal of helping people affected by breast cancer deal with long-term health concerns.
• Diagnostic studies help discover better tests or procedures that may help diagnose a specific disease or condition. This may lead to finding future breast cancer targets for medications and treatments.
Most trials are conducted in phases, and each has a different goal. Phase I trials are the first time a medication is tested in human beings. They study how a medication should be given (by mouth, injection, intravenously) and how it is absorbed. They establish a safe dose range and identify side effects. A small number of people participate.
Phase II trials look at the safety of the medicine, begin to evaluate how it works and sometimes determine the most effective dose. Usually fewer than 100 people participate.
Phase III trials compare the new medication, new combination of medicines or procedure to the current standard treatment. These studies include hundreds of participants. Most medicines or procedures that reach phase III have shown promise in an earlier phase.
Phase IV trials are done after a medicine or treatment has been approved by the Food and Drug Administration. These trials evaluate side effects associated with long-term use that may not have been seen in phase III trials and include thousands of participants.
Trial Protections
To protect your rights and ensure safety, every trial is subject to FDA regulations and must be reviewed and approved by an Institutional Review Board. IRBs are made up of a diverse group of people with a variety of backgrounds and include consumers to ensure a thorough, fair review. They review and approve trials with your safety in mind.
You will be required to sign an informed consent, a document that says you understand the treatment, tests, side effects, possible risks, benefits and costs. Your physician or nurse will review this with you carefully. You have the right to withdraw your consent/participation at any time. The Health Insurance Portability and Accountability Act also protects your privacy by limiting the way hospitals, insurance companies, pharmacies and others share your personal medical information.
Trials are reviewed periodically by a Data and Safety Monitoring Board, an independent group not directly involved with the trial. The DSMB ensures the trial continues to be safe by examining interim data on severe side effects and other technical aspects of the trial.
Real People, Real Choices
Clinical trials can seem abstract until you are faced with a decision. Lisa Ritinski, of North Wales, Pennsylvania, knew little about them until her 1994 diagnosis.
After receiving initial treatment, Lisa decided to take tamoxifen. Several months before she was to finish her five years, her doctor suggested she take part in a Phase III clinical trial for a new aromatase inhibitor, letrozole (brand name: Femara).
To make her decision, Lisa "talked to people of authority, people whose medical opinion I respected. I called them and said, I want to know about your feelings on [this trial]."
Faith in her healthcare team convinced her to participate. The trial, called MA-17, was double blind, which means neither Lisa nor her oncologist would know whether she was taking the study medication or a placebo, a sugar pill. A placebo was included because no one knew whether taking a medication after five years of tamoxifen would be beneficial.
As part of the trial, Lisa received her medication for free. She kept a daily log, and received calls from a research nurse every few months.
The trial ended early when an interim analysis showed a statistically significant difference in survival between participants who took letrozole versus those who took placebo. By ending the trial early, doctors could offer letrozole to anyone who might benefit.
With the end of the study, Lisa’s oncologist could learn which study medication she had been taking. It turned out to be the placebo. Her doctor immediately called in the prescription for letrozole.
"I had mixed feelings at first," Lisa says. "But I wasn’t upset. I received the standard treatment, and I was OK. Then I benefited from the new treatment."
In addition to double-blind trials, there are single-blinded trials (you do not know which treatment you are receiving but your doctor does), open-label (all participants receive active medication) and non-blinded (both you and your doctor know what medication you receive).
The possibility of receiving non-active medicines in a trial frightens many people, says Judy Perotti, co-founder of the Research Advocacy Network (http://www.researchadvocacy.org/).
"When you’re diagnosed, you feel like you’ve lost control. Then someone comes along and [asks you to] consider being in a randomized trial," Judy says. "It goes right back into the patient’s lap, the idea that you’re going to let somebody else choose."
Judy, who has had breast cancer twice, explains that trials are conducted this way to help ensure results are not biased by beliefs you or your doctor may have about the effectiveness of treatment.
Understanding trials can sometimes be overwhelming. Malaya (Maia) Rogers, of Denver, took part in an open-label chemotherapy trial when she was diagnosed in 2002 at age 35. She met with her oncologist and a clinical trials research nurse, who took her through the pros and cons, possible benefits and side effects. Even with her background in health care Maia felt overwhelmed by the long informed consent form. But she says you should not let the form deter you; instead, talk to your nurse or doctor, who can answer your questions.
"We relied on our nurse’s oral presentation," Maia says. "I wanted to participate because of my oncologist’s recommendation and the chances for improved results."
The timing of conversations can be important. Kirby Giaramita, of Campbell, California, is a hairdresser and single mom who was diagnosed five years ago. Her doctor asked her about clinical trials at their first meeting.
"I’m not sure if I didn’t fully understand clinical trials at the time, or if I was really still in shock," Kirby says. "I just wanted to do what I needed to do and get back to my life. I told my oncologist I wasn’t interested, and the subject never came up again."
Once Kirby completed treatment, she started reading more. "I could see [from a quick search] there were thousands of clinical trials." Now when a woman comes into her salon with questions, Kirby tells her everything she knows.
This kind of communication can be vital. Caroline Evans, of Rydal, Pennsylvania, did Internet research after she was diagnosed with Stage IIIB inflammatory breast cancer. But it was a friend with breast cancer who recommended an open-label phase I vaccine trial in New York. She told her oncologists, and they encouraged her to take part.
"Trust is the most important aspect in making the decision to participate in a clinical trial," says Margo Michaels, MPH, executive director of the Education Network to Advance Cancer Clinical Trials (ENACCT; http://www.enacct.org). "Trust is something that cannot be sold or bought. It’s trust in your doctor, and relationship building."
Special Barriers
Just 5 percent of people affected by breast cancer enroll in clinical trials. People who do not participate cite a variety of reasons, including wanting to stay with a proven standard treatment, money concerns around travel and insurance and discomfort with large hospitals or unfamiliar doctors. These barriers and others have a strong impact on minority and elderly women, who participate even less often than the rest of the population.
Carmelita Austin-Schreher, of Santa Cruz, California, was diagnosed eight years ago. An African-American woman with five sisters, Carmelita was concerned about the impact of breast cancer on her and her family.
"I already knew clinical trials help people get state-of-the-art and top-of-the-line technology," she said. "But my family practitioner didn’t know where to send me or lead me to."
On her own, Carmelita found a trial for sentinel node biopsies. But to participate she would have had to travel out of her county more than an hour to a university cancer center.
"It was more important for me to have my family and their emotional support around me," Carmelita says. "There was no offer of money to pay for me to get there or bring my family with me. If trials aren’t offered in your area, or there’s no way for you to pay for the costs of travel, it’s hard for a lot of people."
Social workers or community agencies can help you find organizations that help with travel costs. In many cases, you can participate in clinical trials at local community hospitals, veterans’ hospitals and even your doctor’s office, says Ms. Michaels. Your doctor can apply to take part in the National Cancer Institute’s Cancer Trials Support Unit (CTSU), which allows individual physicians and hospitals to participate in large trials regardless of their location. For more information, visit http://www.ctsu.org.
Making the Decision
Participating in a clinical trial is a personal decision that you make with the input of your healthcare team and loved ones. Write down your questions or speak into a tape recorder before visiting your healthcare provider.
• Ask if your doctor participates in clinical trials. If not and you want to learn more, persist in asking for more information.
• Ask other people who had cancer treatment whether they participated in clinical trials and why.
• Use your local public library or the Internet. Your nurse or social worker can direct you to trustworthy resources.
• Ask about side effects. Will they interfere greatly with your quality of life? Measure them against the potential benefits and your current work status and lifestyle.
• Ask what happens should you have a recurrence during the trial or decide to withdraw. What medical options would you have? Would the trial treatment impact them?
• Bring someone with you to listen and take notes at your appointments. Keep a notebook to gather information in one place. Review it and discuss your options with other doctors or family members.
Besides receiving a possibly better or less toxic treatment, participating in clinical trials can make you feel good for a long time after your cancer experience.
"It was really rewarding to read [in a magazine] that my trial was one of the top 10 medical breakthroughs of 2003," says Lisa. "Wow. I was part of that. I actually did that, and that’s pretty cool, particularly for someone who doesn’t have any trophies on her wall."
To find out more about trials in your area, visit http://www.cancer.gov, the website of the National Cancer Institute. You can search by state and type of trial. It also provides you with the trial coordinator’s contact information. Many U.S. cancer centers also have individual websites to help you in your quest to find a clinical trial for you or someone you know. On LBBC''s site, you can visit http://www.lbbc.org/clinical-trials-resource-center.asp
Janet Beatty—Young Woman Manages Breast Cancer, Gathering Strength for Her Family
When Janet Beatty learned she had breast cancer just six weeks before her wedding, she thought, "I don’t have time for this." At age 29, living in Chicago, breast cancer was the last thing Janet expected.
Because she had no family history and was young, Janet did not think she was at risk. Neither did her doctors. When Janet went to her gynecologist, he said, "You are young. It’s nothing." Still, he suggested she call a surgeon. The surgeon recommended a biopsy to rule out cancer. Janet did not feel alarmed, so the results caught her off guard.
"When my fiancé, Eric, and I were asked to step into a side room of the surgeon’s office, I still did not think [it was] cancer," she says. "When the surgeon told me it was, I felt numb and I couldn’t follow the conversation. I thought about the wedding and the honeymoon and I thought, how is breast cancer going to fit into these plans?"
Janet, Eric and her healthcare team decided on an aggressive course of treatment for her Stage 2, estrogen receptor-positive breast cancer. Her treatment plan included chemotherapy twice a month for six months, followed by 38 daily radiation treatments to her breast.
From the beginning, Eric played an active part in Janet’s recovery. He began researching breast cancer right after her diagnosis, and they decided together that Janet should begin chemotherapy treatment immediately. Janet received her first treatment two weeks before their honeymoon to the South Pacific.
Eric escorted Janet to every appointment, attended all meetings with doctors and continued to educate himself. Being able to ask questions when they met with doctors enabled him to counter his feelings of powerlessness, Janet says.
Because Eric had taken a job in Philadelphia, he and Janet moved from Chicago in August 1996, only three months after her diagnosis. The move was a "blessing in disguise," she says. When the couple arrived, they faced the grueling task of building a new healthcare team in a new city. Together, they interviewed many doctors at various hospitals until they built a team they liked and trusted.
Since Janet and Eric wanted a family, they were concerned about how breast cancer treatment would impact Janet’s fertility. They were pleased that their new healthcare team encouraged their questions and concerns.
"It felt good knowing that you have a doctor who treats the whole person," she says.
After her last radiation treatment in February 1997, Janet received a very favorable prognosis. To decrease her chances of recurrence further, her doctors recommended she take tamoxifen (brand name: Nolvadex). But Janet hesitated. She and Eric were ready for children, and they knew that women taking tamoxifen should not become pregnant. Eric and Janet felt they had "done enough" and decided against tamoxifen.
However, some chemotherapy regimens may also affect the way the ovaries function, especially in women under age 40. They may cause an interruption in the menstrual cycle or put women into premature menopause. Janet went into temporary menopause for three months during chemotherapy, but her menstrual cycle returned by the time she finished radiation. Three months after she completed radiation, Janet saw her radiation oncologist, Marisa C. Weiss, MD, for a routine check-up. During the exam, Dr. Weiss discovered Janet was pregnant. The couple’s first child was born January 1998, one year after Janet’s last treatment.
While living in Philadelphia, Janet also became involved with Living Beyond Breast Cancer. She became an avid volunteer for LBBC’s Survivors’ Helpline, a toll-free hotline that offers guidance, information and hope in a confidential setting. Janet’s volunteer work allowed her to work with other young women coping with the disease.
More than seven-and-a-half years later, Janet and Eric have three children. Janet gave birth to a girl in summer 2000, and she was pregnant with their third child when they moved once again, this time overseas to Belgium. Four months into her pregnancy, doctors discovered that the child she was carrying had a rare genetic disorder.
"Once again, we were asked to have a seat in one of those dreaded side rooms," says Janet. "The doctors were speaking in French and going through books, and we did not understand what they were saying."
They learned that their daughter, Clara, had Treacher Collins Syndrome and would most likely be born with underdeveloped facial and cranial bones and would have to undergo complicated operations even as a baby to ease breathing and other complications.
In a later meeting, the healthcare team suggested Janet and Eric end the pregnancy. But Janet never considered it. "They did not realize that this baby was chosen," she says. After coping with, and recovering from, breast cancer, "You take it as it comes, you figure out what to do and you do it."
Janet and Eric eventually returned to Chicago because of differences over the best medical treatment for Clara. In the United States, Clara underwent numerous successful operations and three years later is "mentally and physically 100 percent a 3-year old," says Janet. "She just looks a little different. Clara has learned that it is normal [for people] to stare, and I can’t waste my time with those people."
With Clara growing older and becoming more independent, Janet now can take time for herself. She takes tap dance classes, meets up with her girlfriends at night, volunteers where needed and plans to donate time to more breast cancer organizations in the future.
"LBBC was my life when I was in Philadelphia," Janet says. Now that she lives in the United States again, she refers women to LBBC who are affected by breast cancer.
Since her diagnosis, Janet is acutely aware of the fragility of life, but she says that she and her family are strong. They share a level of confidence that allow them to face their challenges.
Would you like to be considered for a Survivors’ Profile? Send a short description of your experience to .
Times to Celebrate, Times to Remember: Managing Milestones After Breast Cancer
Kathi Hansen, a 51-year-old retired teacher from Wrightstown, Wisconsin, never felt much like celebrating her birthdays—until she was diagnosed with breast cancer in March 2003.
"While I never minded growing older and being reminded of that, it was not an event that I relished either," she recalls. "But after having cancer, my attitude toward my birthday became much more positive. I love the idea that I am here to celebrate another year of my life, and I am so pleased and proud of the fact. No black balloons or ‘over the hill’ banners for me!"
Lori Flagg, also 51, from Glendale, California, who was diagnosed with inflammatory breast cancer in April 2002, has a very different perspective.
"I used to feel like my birthday was very special," she says. "I looked forward to celebrating it for weeks ahead of time. Now I would rather it not be acknowledged. I just don’t want a big to-do over it. I kind of feel that if I celebrate it, I’m jinxing myself."
Kathi and Lori’s attitudes couldn’t be more different. Yet they represent a trend among women who find that after a breast cancer diagnosis, birthdays and holidays take on new meanings, attitudes shift and in many cases new milestones emerge.
Discussing this topic with women and healthcare professionals, we’ve heard a wide range of attitudes and gathered advice for getting through the holidays—and other major life events—with your sanity intact, and perhaps a new appreciation of what is most meaningful to you.
Milestones During Treatment
For many women in treatment, milestones are understandably pushed aside in favor of the more urgent needs of getting through it all.
Cindi Gibbs, a 36-year-old elementary school teacher and administrator from Silver Spring, Maryland, looks forward to celebrating her birthday in March. "Last year, I was in the thick of treatment," she recalls, "so I didn’t celebrate at all."
Not celebrating, or scaling back on elaborate, time-consuming preparations, is not necessarily a bad thing. But it can be hard to let go and accept help.
Lori used to have specific dates by which certain tasks had to be completed during the winter holidays. "Before I was diagnosed, I did this huge elaborate yard display," she says. "My house had to be the best in the neighborhood, and inside it had to be perfect."
Even when she was going through chemotherapy treatment, Lori forced herself to stick to that rigorous timetable: "I was very anxious because I wanted everyone to think I was normal, even though I didn’t look or feel normal."
It took Lori several years to realize not only that she could let go, but also that she could enjoy not doing everything.
"At some point I had an epiphany and realized there’s so much more to the celebrating than the gifts and lights and decorations," she says. "That epiphany relieved me of the nit-picky obsessiveness, and that’s really, really nice. Now I know I am here to celebrate and be with my family, and that is the important part."
Lori’s epiphany came several years after her diagnosis. According to Mary Jane Massie, MD, a psychiatrist at Memorial Sloan-Kettering Cancer Center, it takes most women a few years to let go of anxieties arising from diagnosis and find new ways of celebrating.
Linda Abrams, PhD, a psychologist from the Philadelphia area who had breast cancer, agrees. She says she finds that "sometimes it’s after getting through treatment and the side effects of treatment that people really let themselves deal with the emotional piece of having had cancer—the exhaustion, the heightened awareness of mortality."
Important points to remember about holidays and other life events:
• Your thoughts and feelings around holidays and other milestones have probably changed since diagnosis.
• There is no right or wrong way to feel, and no two women feel exactly the same.
• How your attitudes evolve can depend on when you were diagnosed, how far along you are in or out of treatment, your type of breast cancer, your feelings about milestones before diagnosis, your family and support networks and your general outlook on life.
• If approaching holidays or milestones make you feel anxious, upset or totally stressed out, there are ways to manage the stress and find new joy and meaning in these special events.
Milestones After Treatment
One important step to gaining a new appreciation is dealing with milestones directly related to diagnosis and treatment.
Dr. Massie says she tries to "help women extinguish a lot of the memories of certain dates—dates of breast removal, diagnosis" and other potentially traumatic events.
"My perspective has always been that we celebrate presidents’ birthdays, not their death days," Dr. Massie says. She gives her clients this example in working with them to transform—or transcend—fears and anxieties about death and find the things they can enjoy in life.
Dr. Abrams says her clients often report feeling anxious or depressed without knowing why. Upon further discussion, they find there’s an anniversary of diagnosis or treatment looming in the very near future.
"The anniversaries are triggers that remind people of their vulnerability," says Dr. Abrams. "The first birthday, or Christmas, or Jewish high holidays after diagnosis can also be a strong trigger."
In dealing with milestone-related triggers, Drs. Abrams and Massie help women talk about their fears and move beyond them.
"Women work so hard during treatment. Everybody’s terrified, but there comes a point—depending on a woman’s stage of disease—when it’s time to put the hospital and cancer office behind and get on with the more pleasurable parts of life," Dr. Massie says. "In fact, many of my patients feel that life is more precious after they’ve survived cancer."
This feeling seems to be shared by many women, of many different ages and stages of disease.
"I hold my diagnosis date sacred," says Cindi. "Not because it was the day when my world collapsed, but I consider it my day of ‘rebirth,’ when I began to see life through different eyes."
Lori, who still lives with inflammatory breast cancer, shares these sentiments. "Every time I have a birthday I think that’s another year of my life," she explains. "We celebrate April 23rd—the date I discovered my giant swollen breast. Every year I live past that I feel gifted. I don’t mourn my diagnosis day. I count it as every year I become more victorious."
Managing Holiday-Related Stress
It’s normal to feel stressed and anxious about upcoming events. But remember also that there are ways to lower the stress and increase your enjoyment.
Make a list of people you can depend on for help: a friend or neighbor who’s good at listening, a partner or child who’s a good household helper. Then ask for the help you need.
Professional counselors and mental health workers can offer much-needed support. Ask your oncology team for recommendations, or check with a local hospital or clinic.
Talk to a woman affected by breast cancer on LBBC’s toll-free Survivors’ Helpline at 888.753.LBBC (5222). Helpline volunteers offer guidance, information and hope in a confidential setting.
Pamper yourself. In the past you may have spent all your energy making the holidays special for everyone else, and then collapsing in utter exhaustion. This year, buy yourself a present. Get a massage or a facial. Treat yourself and a loved one to a special dinner (without cooking it!).
Try to focus on the things that make the holidays special for you: spending time with loved ones, getting in touch with a long-lost friend, spending quiet time by yourself.
Instead of worrying about creating the perfect yard display or baking the best holiday cookies, spend time creating memories to cherish throughout the year.
Celebrations Small and Large
If you are living with advanced disease, it can be much more difficult to achieve the transformations described here. Dr. Abrams tries to help women living with metastatic disease manage the unknown.
"One way to do that is to enumerate where you are in control and how you can take control," she says. "For example, a patient might say she wants to lose weight. That’s something she can take control of and celebrate when she succeeds."
Lori experienced this when she lost 90 pounds several years after her diagnosis. "I’m 4’11" and I weighed 200 pounds," she recalls. "So I became a Weight Watcher leader, and now, every day I get on the scale and haven’t gained weight is a milestone."
That sense of gratitude for daily accomplishments, and wonder at seasonal events, marks many women’s experiences.
"I have learned to appreciate small events just as much as big ones," Lori says. "The first day of spring, a thunderstorm, fall." She has also found a new sense of wonder and joy in family celebrations.
"My new milestones are now my grandsons’ birthdays," Lori says. "I look forward to my youngest getting married and seeing her raise her family (soon, I hope). And I look toward the day when I can afford to travel. I have been saving money for my 5-year ‘re-birthday.’ I would love to go to Fiji."
Creating Memories
One of the most important realizations in managing cancer-related and other anxieties around milestones is an awareness of family and loved ones and a renewed appreciation of times spent together.
Debbie Osborne, a 49-year-old former nurse from Oley, Pennsylvania, was diagnosed with metastatic breast cancer the day after Thanksgiving four years ago. Ever since, Thanksgiving has been a time of "heightened awareness" for her. At first, it was mostly painful, but now she looks at it differently.
"Before I would shut down the week before Thanksgiving. I couldn’t wait for it to be over," she recalls. "Now, every holiday, every Thanksgiving, is like: Wow! I’m still here to celebrate."
Once she started celebrating Thanksgiving again, Debbie discovered joy in many other occasions. "Milestones are a thousand-fold different for me now," she says. "When my son graduated from high school, you would have thought he got married, had a baby and was king of the universe!"
Debbie’s fiftieth birthday is coming up and she’s planning to spend it with her husband and three sons. "I told my husband I don’t want any party or anything, just to be with my family. We decided to do a family vacation," she says. "This is giving me such happiness, hope and strength, to think now about a vacation in a few months’ time. It’s creating memories, and memories can give you a lot of strength in low times."
Cindi echoes these sentiments. "My thoughts go much deeper than just the date," she says. "I spend my time now remembering my nephews’ great smiles and the way they strutted proudly off the football field after helping their team win their game this fall. I recall how sweet my other nephew smelled when he snuggled into me for a hug on that cold Christmas morning at my parents’. I remember how warm I felt inside that Thanksgiving Day when my entire family was together giving thanks for everything good that God has given us, knowing that Mom’s macaroni and cheese was just about to be served—one of the few dishes I continued to eat throughout chemo."
"I really try to think about what makes those milestones significant," Cindi concludes, "and that makes all the difference."
