The U.S. Food and Drug Administration (FDA) is finally acknowledging a too-often-ignored subset of patients with breast cancer: men. According to a new draft guidance document released yesterday, most FDA-approved breast cancer drugs are tested in clinical trials that enroll either no male patients or too few male patients. The document urges the industry to do a better job including these roughly 2,000 men who are diagnosed with breast cancer in the U.S. each year.
“Most men don’t know they can get breast cancer,” Michael Singer, a male breast cancer survivor and outspoken advocate told SurvivorNet in a previous conversation about how men can get breast cancer, too. “They don’t know that breast cancer will kill them… I came from a place of silence to now being outspoken… Now you can’t shut me up about male breast cancer.”
Read MoreThe FDA document lays out recommendations for the drug industry to include more males in their breast cancer clinical trials. One of these recommendations includes expanding eligibility criteria — which determine who can and can’t participate in clinical trials — to include both males and females.
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The FDA also recommends that female clinical trial results should only be extrapolated to apply to men as well in cases where enough data exist to show that doing so would be safe and similarly efficacious. For example, breast cancer drugs that rely on manipulating hormones, such as endocrine therapy, may affect men differently than women; in these cases, the FDA is urging the use of “different data sources, including small-single arm trials and studies using real-world data sources.”
“It’s Not a Women’s Disease” — Including Men in Conversations About Breast Cancer
When men receive breast cancer diagnoses, as the FDA acknowledges, they’re often treated with drugs that were initially tested in women alone. But that’s not the only issue male patients with breast cancer face; they also have to deal with the overwhelming stigma of breast cancer as a “women’s disease.”
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When SurvivorNet spoke with breast cancer survivor Marc Futterweit, he shared that, when he first received his diagnosis, he didn’t tell his family.
“Men [with breast cancer] are basically standing in the shadows,” he said. “They’re ashamed or embarrassed– this is a woman’s disease, this, that, and the other.”
Futterweit went on to urge other men with breast cancer to “just remember, it’s nothing that you have done to cause you to get breast cancer. It’s nothing to be embarrassed about. It’s not a woman’s disease. You’re not alone.”
Futterweit’s words echoed those of Michael Singer, who told SurvivorNet he is on a mission to raise awareness and get more people talking about the disease.
“I’m one of the only men I’ve ever really heard of in my area who talks about male breast cancer, and advocates for male breast cancer,” Singer told SurvivorNet.
Singer, who rides a motorcycle, said “most people look at a biker and say, ‘that guy ain’t got breast cancer.'” To Singer, the motorcycle has been an opportunity to defy the stereotype and get more people talking about the unexpected and rare — yet very real — diagnosis.
Singer said that he and his wife lobby Congress every year, demanding increased funding from the National Cancer Institute to treat male breast cancer.
While the draft guidance that the FDA just released will not be a legally binding requirement, when finalized, it “will represent the current thinking of the FDA on this topic.”
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