FDA Says Men Should Be in Breast Cancer Studies

Save as Favorite
Sign in to receive recommendations (Learn more)

Men should be included in breast cancer clinical trials, according to draft guidance issued by the U.S. Food and Drug Administration (FDA) on Aug. 26, 2019.

Read the FDA statement.

Read the draft guidance.

“When finalized, the recommendations in the draft guidance will provide clarity for industry regarding how additional data to support efficacy and safety for male patients with breast cancer can be generated through a variety of trial designs using different data sources, including studies using real-world data,” Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence, said in a statement. “We hope that the recommendations in the draft guidance … will, when finalized, encourage drug development for the treatment of male breast cancer and ultimately, provide additional FDA-approved treatment options for patients.”

The draft guidance is open for public comments until Oct. 26, 2019. To submit a comment, click on the link to the draft guidance above.

Male breast cancer

While breast cancer in men is rare, it does happen. Fewer than 1% of all breast cancers are diagnosed in men. In 2019, about 2,670 new cases of invasive breast cancer will be diagnosed in men. For men, the lifetime risk of getting breast cancer is about 1 in 833.

Like breast cancer in women, breast cancer in men can be hormone-receptor-positive or hormone-receptor-negative, as well as HER2-positive or HER2-negative.

Because the number of cases of breast cancer in men is relatively small compared to the number of cases in women, there is a lack of information on male breast cancer in general. Treatment decisions for male breast cancer are usually based on studies in women.

“While some FDA-approved treatments are gender-neutral in their indication, many therapies are only approved for women and further data may be necessary to support labeling indications for men,” Pazdur said.

“Amazing news from the FDA!” wrote Michael Singer, a member of the Male Breast Cancer Coalition who was treated for stage IIB breast cancer, on his Facebook page. “Male Breast Cancer: Draft for New Guidance for Treatment announced that men should be included in drug trials or provide written rationale in the protocol when proposing to exclude us. Being excluded has resulted in limited FDA-approved treatment options for men with breast cancer. Finally, we are being heard! We finally matter — the 1% matters!”

What this means for you

If you are a man who has been diagnosed with breast cancer, the FDA’s draft guidance is good news. Clinical trials are an important step in discovering new treatments for breast cancer and other diseases as well as new ways to detect, diagnose, and reduce the risk of disease. Clinical trials show researchers what does and doesn’t work in people. Clinical trials also help researchers and doctors decide if the side effects of a new treatment are acceptable when weighed against the benefits offered by the new treatment.

If you would like more information about clinical trials, including how trials are conducted and the benefit and risks of participating in a trial, visit the Breastcancer.org Clinical Trials pages.

To search for a clinical trial that might be right for you, visit ClinicalTrials.gov.

To discuss male breast cancer with other men who have been diagnosed, join the Breastcancer.org Discussion Board forum Male Breast Cancer.

Written by: Jamie DePolo, senior editor

Reviewed by: Brian Wojciechowski, M.D., medical adviser


Was this article helpful? Yes / No

Fy20octappeal sidebar a
Back to Top