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FDA: Men With Breast Cancer Need More Treatment Options and Access to Genetic Counseling

Although breast cancer is a disease usually associated with women, men can get it too.

Because male breast cancer is rare, there is very limited information on how to treat men diagnosed with the disease.

“In the absence of better information to guide us, we tend to treat men with breast cancer the same way we treat women,” says Tatiana M. Prowell, M.D., a breast cancer scientific liaison at the U.S. Food and Drug Administration. “Men have historically been excluded from breast cancer clinical trials. In the last few years, we’ve begun asking drug companies to allow men in clinical trials unless there is a valid scientific reason to exclude them.”

The response from companies, researchers, and patients has been very positive. Breast cancer awareness is growing, and now most breast cancer trials being designed include men. “In fact, trials supporting a few recent FDA drug approvals have included men with breast cancer, allowing for the drug to be then approved for both men and women with breast cancer,” says Suparna Wedam, M.D., a breast cancer scientific liaison at the FDA.

The FDA finalized a guidance, Male Breast Cancer: Developing Drugs for Treatment, to help facilitate drug development for men with breast cancer. The guidance recommends the inclusion of men in clinical trials of breast cancer drugs unless there is a scientific reason for their exclusion.

Symptoms of Breast Cancer in Men

Each year, about 2,000 cases of male breast cancer are diagnosed in the United States, resulting in about 500 deaths, according to the National Cancer Institute. Although it can strike at any age, breast cancer is usually diagnosed in men ages 60 to 70.

Why does it often take so long to recognize the signs of breast cancer in men? One reason for the late-age (and later-stage) diagnosis may be that men, and their doctors, don’t think they are at risk of breast cancer.

“You’d think that because men have smaller breasts, they would get diagnosed at an earlier stage than women,” Prowell says. “In many men, though, diagnosis is actually delayed because men and their doctors aren’t expecting a breast lump to be cancer.”

Most men with breast cancer have painless lumps they can feel. The lumps can develop anywhere on the breast and often are underneath the nipple and areola complex – right in the center. Because men don’t have regular mammograms, their breast cancer may be discovered after a local injury, such as a fall or minor chest wall trauma, leads them to feel the breast area.

“Men commonly attribute a breast lump to some sort of injury. The mass was already there, but they didn’t notice it until it got sore after they were bumped in the chest, for example,” Prowell explains.

Risk Factors of Breast Cancer

Men and women share some similar risk factors for breast cancer: high levels of estrogen exposure, a family history of the disease, and a history of radiation to the chest. Although all men have estrogen in their bodies, other factors such as obesity, cirrhosis (liver disease), and Klinefelter’s syndrome (a genetic disorder) can increase estrogen levels. All are known risk factors for male breast cancer.

If a close relative – their mother, father, brother, sister, child – has breast cancer, men are also at slightly higher risk to develop the disease. Men who have a BRCA mutation, a mutation or change in a gene that predisposes them to breast cancer, are at a greater risk. Although their chance of developing breast cancer is still low (only about 5% to 6%), men with a mutation in BRCA2 have a 100 times greater risk of developing breast cancer than men in the general population.

“In men and women, having a tumor with estrogen and progesterone hormone receptors is more common than not – but that appears to be even more true in men,” Prowell says.

Breast Cancer Treatments for Men

Treatment options for men are similar to women’s: mastectomy, which is surgery to remove the breast, or in some cases lumpectomy, radiation, chemotherapy, targeted therapies, and hormone therapy. Hormone drug treatments include aromatase inhibitors or tamoxifen, which lower estrogen levels in the bloodstream or prevent estrogen in the bloodstream from interacting with estrogen receptors on breast cancer cells.

When used in men, aromatase inhibitors are often given in combination with another drug – luteinizing hormone-releasing hormone agonist (LHRH) – to adequately suppress estrogen levels. An LHRH agonist keeps the testicles from making sex hormones by blocking other hormones. Wedam explains that this is important because aromatase inhibitors are commonly used in combination with cyclin-dependent kinase (CDK) inhibitors, which treat hormone receptor positive breast cancer that has spread outside of the breast.

For men with larger tumors or tumors that have spread outside of the breast, chemotherapy is often recommended in addition to hormone treatment, just as it is for women. And men whose tumors are HER2 (human epidermal growth factor receptor 2) positive or have certain changes (mutations) in them are recommended to receive treatment with drugs that work against those targets, just as women are.

Genetic Counseling Is a Must for Men

All men with breast cancer should be referred for genetic counseling, Prowell advises.

That’s another difference from women, who are not automatically referred to a genetic counselor for genetic testing, such as for mutations in BRCA-1 or 2. Even among men there are differences. African American men are more likely than white men to have advanced stage tumors at diagnosis and to develop triple-negative cancers. Their types of tumors are more likely to recur and have fewer treatment options.

People should tell their health care provider if any man in their family has had breast cancer, Prowell says. “Even if your grandfather is deceased, if he had breast cancer, that’s important. Because male breast cancer is so rare, seeing even one man in a family lineage raises concerns about hereditary breast cancer,” Prowell adds.

Source: https://www.fda.gov/consumers/consumer-updates/men-breast-cancer-need-more-treatment-options-and-access-genetic-counseling

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