FDA: Men should be included in breast cancer clinical trials

Men should be included in clinical trials of new breast cancer treatments, the U.S. Food and Drug Administration says.

“Less than 1 percent of all breast cancer cases occur in men, but men are more likely to be diagnosed at an older age and have a more advanced stage of disease. As breast cancer in men is rare, they have typically not been included in clinical trials for breast cancer treatment,” according to an FDA news release. “This has led to a lack of data, so their treatment is generally based upon studies and data collected 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.”

The draft guidance that men be included in breast cancer clinical trials was issued by the FDA on Aug. 26.

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