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Including Men in Breast Cancer Trials (Finally!)

September 03, 2020

Including Men in Breast Cancer Trials (Finally!)

by Bob Riter

When I was diagnosed with breast cancer in 1996, I was told, “We don’t have much data about breast cancer in men, so we’ll treat you pretty much like we would treat a post-menopausal woman with breast cancer.”

I knew it was the best they could do at the time, but it wasn’t reassuring. Of particular concern were endocrine treatments. It doesn’t take a PhD to recognize that men and women have very different hormonal profiles, and what works for women with breast cancer may not work the same for men. There wasn’t good data on men with breast cancer because most breast cancer trials specifically excluded men.

Nearly twenty-five years later, this is beginning to change. The FDA recently released Male Breast Cancer: Developing Drugs for Treatment Guidance for Industry which recommends that research trials for breast cancer drugs include men with breast cancer, and is encouraging researchers to contact the FDA early in their research planning for guidance on enrolling men. The default is now that men should be included in all breast cancer trials, and there needs to be a scientific rationale if they are excluded.

To illustrate the importance of including men with breast cancer research, take the example of PARP inhibitors. They are relatively new and are used for breast cancers in individuals with BRCA mutations. Did you know that up to 14% of men with breast cancer have a BRCA2 mutation? We need to be included in the latest research if our treatment is to be based on the latest evidence.

When I was diagnosed, genetic testing for breast cancer was not routine, but I had assumed that I had a BRCA2 mutation because of my Ashkenazi Jewish heritage, my relatively young age at diagnosis, and the fact that my mother died from pancreatic cancer.

It was an elevated PSA test just a few months ago that finally prompted my germline genetic testing. Surprisingly, I didn’t have a BRCA mutation, but did have a CHEK2 mutation. Fortunately, I did not have prostate cancer, but my CHEK2 mutation likely increases my risk of developing it in the future. I’ve already enrolled in a National Cancer Institute study for men at high genetic risk for prostate cancer because I want to participate in meaningful research that furthers our understanding of hereditary cancers.

I applaud FORCE and many cancer support organizations that called on the FDA to include men in breast cancer trials. The new guidelines offer men with breast cancer - and hereditary cancers more broadly - a brighter future.

Bob Riter is a FORCE research advocate. He lives in Ithaca, NY and serves as the Patient Advocate within Cornell University’s Physical Sciences and Oncology Center. http://blogs.cornell.edu/cancercommunitypartnership/

Posted in: Men With Mutations
Tags: Breast Cancer, Clinical Trials, Male Breast Cancer, Research

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