FDA Calls For Men To Be Included In Breast Cancer Clinical Trials

Although breast cancer in men is not often publicized in the media, it is very important to know that men are at risk of the disease too. It is estimated that about 2,600 men will be diagnosed and 500 will die of breast cancer each year. However, because men contribute less than 1% of all cases, they are typically not included in clinical trials for treatment.

Since men have not historically been included in clinical trials, it is very possible they are not receiving optimal care. The drugs and treatment options they are prescribed have only been tested and approved for women.

The Food and Drug Administration (FDA) is calling for this to change. In their recent draft guidance, the FDA recommends the inclusion of men in breast cancer clinical trials to help improve the clinical management of the disease in male breast cancer. The FDA also states that if researchers propose to exclude male patients from a breast cancer trial, “scientific rationale should be included.” Furthermore, the FDA will not consider “low expected accrual rates of male patients with breast cancer” as sufficient rationale for excluding male patients moving forward.

The move seems to be working already… Following the FDA’s announcement, some breast cancer drug studies have extended eligible enrollment criteria to men.