Regulators, Doctors Say More Breast Cancer Trials Needed For Men

There are 2,360 new cases and 430 deaths in men each year due to breast cancer, according to the Cancer Institute. Although these stats pale in comparison to cases in women – only one percent of all breast cancer cases — it doesn’t mean targeted therapies aren’t needed.

Regulators admit that the majority of companies conducting studies for new breast cancer therapies only enroll women for their clinical trials. And doctors agree, saying it’s hard for them to learn more about male breast cancer because so few men are diagnosed, therefore very few participate in clinical studies, according to cancer.org.

Regulatory Affairs Professionals Society (RAPS) reports that this results in a serious regulatory problem: very few drugs on the market have undergone testing in men and aren’t proven to work in men.

"Our data on treatments for men are largely based from trials that were conducted in women, or they are retrospective data from a collection of men who were treated over a period of time," Tatiana Prowell, breast cancer scientific lead at the FDA’s Office of Hematology and Oncology Products, explained.

She adds that large, randomized trials for men just don’t happen. The majority of data collected are based on studies conducted in women or in a smaller collection of men who were treated for a certain period of time.

Currently, there are four types of breast cancer found in men:

• Infiltrating ductal carcinoma
• Ductal carcinoma in situ
• Inflammatory breast cancer
• Paget disease of the nipple

Survival for men with breast cancer is similar to that of women when their stage at diagnosis is the same.  However, men are historically diagnosed with breast cancer at later stages because women tend to recognize a breast lump as potential cancer, whereas men don’t and are slower to seek medical help.

Prowell said FDA is now "actively encouraging drug companies to include men in all breast cancer trials unless there is a valid scientific reason not to."