Breast Cancer in Men and Clinical Trial Disparities

This publication was approved and written in close collaboration with Dr. Wendy Woodward.

Wendy Woodward, MD, PhD is Professor and the Chief of the Clinical Breast Radiotherapy Service in the Department of Radiation Oncology at The University of Texas MD Anderson Cancer Center. Dr. Woodward is a featured expert in our health equity-focused Pro Hub that lists inclusive global healthcare professionals committed to advancing inclusive research and providing the highest quality care to all patients.

These articles are written by Diverse Health Hub to summarize complex medical research in order to facilitate deeper understanding. Diverse Health Hub publications are not intended to persuade its readers. We present information to create in-depth conversations that encourage patients to critically think and decide for themselves.

Though some may not realize it, breast cancer can occur in men. Looking at statistics, breast cancer occurrence in individuals with primary male sex characteristics makes up 0.95 percent of U.S. breast cancer cases, and the incidence of men with breast cancer is on the increase. However, in breast cancer clinical studies, there’s a continued lack of data about impact on male breast cancer patients. In our persistent efforts at DHH to spotlight underserved patients, here’s a look at a study examining the exclusion of men from Phase III breast cancer clinical trials.

Disparities in Male Breast Cancer and Treatment

In the study, clinicians looked at the data for randomized clinical trials in the ClinicalTrials.gov database. As the gold standard for reliable clinical trial data, randomized clinical trials were the focus of the study. Of the 131 randomized clinical trials, the total study group was comprised of only 0.087 percent of male patients versus a 0.95 percent occurrence rate. And some of the randomized clinical trials were trials that randomized or mandated hormone therapy, which can exclude men from the trials.

Due to the lack of study data on male breast cancer, treatments for men are frequently derived from studies on female breast cancer patients. Increased inclusion of men in breast cancer clinical trials at a higher percentage will be crucial in continuing to improve treatments specifically for male patients. Though men typically are diagnosed with easier-to-treat estrogen/progesterone-positive breast cancer, their breast cancer survival rates are lower in comparison to female patients.

Breast Cancer Treatment for Men

The study also looked at the types of breast cancer in men versus women. According to study data, the greatest overall breast cancer survival rate in men is highest in those who receive adjuvant hormone therapy with hormone receptor-positive breast cancer. The study shows the specific breakdown of breast cancer treatments at similar rates as women with breast cancer. Overall, about 96 percent receive mastectomy, 49 percent receive radiotherapy, and 77 percent receive adjuvant endocrine therapy.

In looking specifically at estrogen receptor-positive breast cancer in men, this breast cancer type represents 92 percent of cases. Due to their underrepresentation in clinical trials, men with breast cancer are given treatments derived from female breast cancer studies. But this data would likely change if breast cancer treatment becomes more targeted for men. According to Dr. Gary Puckrein who commented about clinical trials, “What we’re finding is that we need highly targeted medicine, each individual is different. It has nothing to do with race or anything like that – it’s that everybody’s biology is different.”

Improving Equity and Treatments for Male Breast Cancer

Looking to the future, concerted efforts by clinicians, patient advocates, and patients must be made to bring greater representation of men in randomized Phase III clinical trials for better patient outcomes – especially those involving studies of endocrine therapies. Advocates can write to those in Congress to get increased funding for this underrepresented group. And awareness can be increased about the disparity by educating others in patient advocacy groups and support groups.

As Dr. Puckrein shares about building learning communities, “If you bring physicians and patient advocacy groups, the policy makers and others around the table, you can solve problems like that and solve them quickly and inform the healthcare system so it’s interactive, it’s constantly learning. And so, we encourage people to build those – make them data driven. Use the data to help guide you on what interventions will work and how you’ll get the best possible outcome for patients.” With continued efforts to increase clinical trial participation of men with breast cancer, therapies that work more effectively in men will continue to be improved for future patients.

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Source

Kelsey L. Corrigan, Walker Mainwaring, Austin B. Miller, Timothy A. Lin, Amit Jethanandani, Andres F. Espinoza, Matt Piotrowski, C. David Fuller, Michael C. Stauder, Simona F. Shaitelman, George H. Perkins, Wendy A. Woodward, Sharon H. Giordano, Benjamin D. Smith, Ethan B. Ludmir. Exclusion of Men From Randomized Phase III Breast Cancer Clinical Trials. The Oncologist. Accessed September 28, 2021. https://doi.org/10.1634/theoncologist.2019-0871