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Wednesday, April 22, 2015

Including men in breast cancer trials

The FDA wants drug companies to include men in breast cancer clinical trials because there’s surprisingly limited knowledge on male treatment methods.
Male breast cancer doesn’t have the activists or advocates like female breast cancer has.  Male breast cancer is a less known and less spoken about breast cancer than female breast cancer.  It’s one hundred times less common among men than among women.
In 2014, an estimated 2,360 men in the United States will be diagnosed with invasive breast cancer, resulting in about 430 deaths.   But the limited pool of victims has heightened the burden on those affected.   Males comprise about 1% of the diagnosed breast cancer cases in the United States each year and they are seldom included in clinical trials and research. 
“Men have historically been excluded from breast cancer trials,” said Dr. Tatiana Prowell, a breast cancer scientific lead at the FDA’s Office of Hematology & Oncology Products, on the FDA’s website this past June. “We are actively encouraging drug companies to include men in all breast cancer trials unless there is a valid scientific reason not to.”
“There’s more of a stigma for men to report anything in their breast,” Dr. Meyers said. “[Men] aren’t really thinking ‘breast cancer’ when they feel a lump.”
It’s possible that successful treatment of breast cancer could differ between males and females  but that isn’t truly known because of the lack of males in clinical trials.
Male exclusion is particularly problematic at a time when many modern and promising breast cancer drugs are available only through clinical trials.   There’s an uncertainty also regarding  the hormonal involvement in breast cancer.
While the survival rate, stage-for-stage, is similar for males and females, men do face a unique set of problems, Dr. Meyers continued. “The biggest problem with male breast cancer is not being aware [until] a later stage. In addition, because males do have less breast tissue, if the tumor is not picked up right away there might be a greater risk of locally advanced breast cancer—which carries a poor prognosis.”
Increased male enrollment in clinical trials might redress another issue, too: awareness. “There’s more of a stigma for men to report anything in their breast,” Dr. Meyers said. “[Men] aren’t really thinking breast cancer when they feel a lump, and they’re sometimes embarrassed by it.
The FDA is trying proactively steering drugmakers to include males in the clinical trials, and that’s something that is not seen very often, particularly in oncology

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