FDA Recommends Including Men in Breast Cancer Trials

Man meets with a doctor

Breast cancer in men is rare, but it does occur.

Male breast cancer is very rare — less than 1% of breast cancer cases in the U.S. occur in men. Historically, men have been excluded from breast cancer clinical trials. The US Food and Drug Administration is seeking to change that. In draft guidelines posted on August 26, the agency says it is recommending that men with breast cancer be included in clinical trials of breast cancer medicines.

Sarat Chandarlapaty, an expert in breast cancer at Memorial Sloan Kettering, says it is a “good step” to include men in studies.

“Given that we often treat male breast cancer the same way that we treat female breast cancer, it’s important that we also include men in these trials,” he says.

Breast cancer in men is not known to be different than it is in women. Today, a man with estrogen-receptor positive breast cancer, for example, is treated with some of the same hormonal therapies used in women. But without studying men along with women in the same trials, there is no way to know for sure that they will respond the same way.  

Given that we often treat male breast cancer the same way that we treat female breast cancer, it's important that we also include men in these trials.
Sarat Chandarlapaty physician-scientist

For large trials conducted nationally or internationally, inclusion and exclusion criteria are often set by centralized committees. Individual cancer centers cannot then deviate from those criteria, even if they want to.

“The FDA guidelines should encourage those committees to take a second look at whether they are excluding men for the right reasons,” Dr. Chandarlapaty says. Just because it may be difficult to recruit men into trials it is not a legitimate reason to exclude them, according to draft guidelines.

Currently, many drug labels for breast cancer medicines do not include men among their approved indications. The drugs are in essence given “off label” to men. Inclusion of men in trials may permit drug companies to list men as an approved indication, which could influence insurance coverage and doctor prescription practices.

MSK medical oncologist Shanu Modi agrees with the FDA’s recommendation to include men in clinical trials. “In this era of personalized medicine, we need to study male breast cancer more rigorously in order to offer these patients the best possible care,” she says.

The draft guidelines are open for public comment until October 26, 2019.

Male Breast Cancer
Learn about how male breast cancer is diagnosed and treated at Memorial Sloan Kettering.