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 According to a new draft guidance document released yesterday, most FDA-approved breast cancer drugs are tested in clinical trials that enroll either no male patients or too few male patients.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.”
Male breast cancer is really rare. But while fewer than one percent of all breast cancer diagnoses occur in males, these cases should not be ignored — especially in the clinical trials that test new treatments. Recognizing this — and the need to better address the unique needs of patients like Singer — the FDA drafted this guidance document, titled, “Male Breast Cancer: Developing Drugs for Treatment.” The guidance won’t be legally binding, but it’s an important acknowledgment on the part of the FDA, which could shift the way the drug industry develops new treatments for males with breast cancer. At the moment, the document acknowledges, men with breast cancer are usually treated based on data gleaned from women.
RELATED: Men Get Breast Cancer Too
“Males have historically been excluded from clinical trials of breast cancer drugs because breast cancer in males is rare,” the document reads. “This exclusion has resulted in limited FDA-approved treatment options for males with breast cancer.”
The 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.
RELATED: Why Do People Get Excluded From Clinical Trials?
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.”
RELATED: The Shock and Awe of Hearing You Have Breast Cancer — Men Need to Know About Risks
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.”
Breast Cancer survivor Marc Futterweit spoke with SurvivorNet about getting around the stigma of breast cancer as only a “women’s disease.”
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.
Breast cancer survivor Michael Singer spoke with SurvivorNet about the important role of advocacy in male breast cancer.
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.”
Learn more about SurvivorNet's rigorous medical review process.
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 More Male breast cancer is really rare. But while fewer than
one percent of all breast cancer diagnoses occur in males, these cases should not be ignored — especially in the clinical trials that test new treatments. Recognizing this — and the need to better address the unique needs of patients like Singer — the FDA drafted this
guidance document, titled, “Male Breast Cancer: Developing Drugs for Treatment.” The guidance won’t be legally binding, but it’s an important acknowledgment on the part of the FDA, which could shift the way the drug industry develops new treatments for males with breast cancer. At the moment, the document acknowledges, men with breast cancer are usually treated based on data gleaned from women.
RELATED: Men Get Breast Cancer Too
“Males have historically been excluded from clinical trials of breast cancer drugs because breast cancer in males is rare,” the document reads. “This exclusion has resulted in limited FDA-approved treatment options for males with breast cancer.”
The 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.
RELATED: Why Do People Get Excluded From Clinical Trials?
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.”
RELATED: The Shock and Awe of Hearing You Have Breast Cancer — Men Need to Know About Risks
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.”
Breast Cancer survivor Marc Futterweit spoke with SurvivorNet about getting around the stigma of breast cancer as only a “women’s disease.”
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.
Breast cancer survivor Michael Singer spoke with SurvivorNet about the important role of advocacy in male breast cancer.
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.”
Learn more about SurvivorNet's rigorous medical review process.
