Clinical Trials and Hurdles for Men With Breast Cancer

June 3, 2016

Diagnosed with stage II ER-positive breast cancer in 2005, Lee Giller, of Akron, Ohio, learned in Fall 2012 that the cancer returned and was stage IV. Lee and his wife, Kathy, discuss his experience navigating clinical trials, participating in the BROCADE study and more in this Q&A for Breast Cancer Trials Matter to You.

UPDATE, 6/4/16: An earlier version of this post contained errors regarding Lee’s information about the BROCADE study and cancer progression. This Q&A has been revised with the correct information.  

Q: How did you find out about the BROCADE study?


My then-doctor in Boston told us about the study and referred us to an oncologist closer to home in Cleveland, Ohio. She informed us about a  phase II randomized blind study for women and men with metastatic breast cancer that’s BRCA-positive. The trial was evaluating the efficacy of a new PARP inhibitor called Veliparib. The doctor made arrangements for us to proceed with the nearest trial, which was in Pittsburgh. Thankfully, I fit the trial’s criteria. Being male, I’m not always eligible for some breast cancer clinical trials that are geared strictly for women.

Q: Did you have any concerns about participating? If so, what were they, and what helped ease those concerns?


I really didn’t – we had cleared it with three very qualified doctors. I felt the trial was tailor-made for me and my best shot at that point. I really didn’t think a lot about it being a clinical trial. 


Unlike Lee, who always has an amazingly positive attitude, I was under the impression that if someone does a clinical trial, that means there’s nothing left for them to try. That worried me. I looked at the study as our last best hope.

Through this experience, I’ve since learned that this is not the case. If you participate in a trial, you have the benefit of getting the best standard care treatment even if you don’t get the new cutting-edge drug. When Lee had his recurrence with metastatic disease he had symptoms like coughing and breathing problems. Ultimately the doctors felt it was important that he had chemotherapy to help alleviate these symptoms, and chemo was part of this study.

Q: Can you describe your experience in the trial?


I had 14 rounds of treatment. It was the kind of chemotherapy reaction where I’d get the infusion, it’d hit me about two days later and then I’d have three-four days of feeling lousy. Then by the time I’d start to have a really good week, it’d have to go through it all over again. It was difficult.

I eventually had toxicity with the carboplatin, which happens around the eighth round for most participants. I lasted 14 rounds before I had an allergic reaction that ended the study for me.


The clinical trial was very effective in alleviating Lee’s symptoms as well as eliminating much of the cancer.  Prior to the trial, the breast cancer had metastasized to his liver, lungs and bones.  After the trial ended, his scans showed “resolution” of the cancer in those areas.  Later, his oncologist gained permission for Lee to try the PARP inhibitor as a single-agent by requesting compassionate care use from the pharmaceutical company.  Unfortunately, severe side effects prohibited Lee from staying on that drug for very long.

Q: Can you comment on your experience finding and/or participating in a research study as a man with breast cancer?


I had a hard time being a man with breast cancer in the beginning. I’ve found that because I’m a man with breast cancer and it’s pretty rare, providers and hospital workers get to know me because I stand out. I’ve embraced it a little as a positive thing.

Since I was first diagnosed in 2005, I’ve had some good conversations with other male patients I’ve come to meet along the way. It’s always given me a great deal of satisfaction to be able to get the word out and advocate for other men with breast cancer.

We’ve come across trial options where Lee couldn’t participate because he’s a man. It makes you wonder what opportunities he’s missing out on because of that.

For example, the description of palbociclib (Ibrance)  which he is taking now, is designed for postmenopausal women. When it was first prescribed, the insurance company denied covering it. The claim was appealed and is now covered, but we had to jump through some hoops. It’s something that needs to be addressed, and thankfully groups like the Male Breast Cancer Coalition and Living Beyond Breast Cancer are helping to do that.


Thankfully, I have a great advocate in Kathy, who is relentless in dealing with the insurance companies.

Q:What tips would you share with other men with breast cancer who are considering clinical trials?

Always try to find the best doctors and make sure you trust them. Do your homework, too, but if you can get two good opinions and those providers agree on a treatment, clinical or not, trust them and follow their advice.


Weigh your options. Look at all of them closely. And know that clinical trials don’t mean “last resort.”

Read more about Lee and other men affected by breast cancer on Male Breast Cancer Coalition's website.

Breast Cancer Clinical Trials Matter to You is sponsored by


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