Should Men Be Included in Breast Cancer Trials?

Breast cancer treatments may affect men differently than women.

Clinical trials for breast cancer typically only include women, which may leave out a critical population who are vulnerable to the disease: men.

A session at the 11th European Breast Cancer Conference suggested that men should be recruited for clinical trials to improve treatments, according to a press release.

Research presented during the conference found that targeted treatments administered before surgery could prevent radical surgery among women with breast cancer.

"These findings could apply to men also, but we just don't know because men with breast cancer are almost never included in clinical trials,” said Robert Mansel, CBE, MB, MS, FRCS, chair of the conference.

Men may respond differently to breast cancer treatments compared with women, but current research does not explore sex-based differences.

"We need trials to start including men, so that we can discover whether or not they respond in the same way to targeted treatments as women,” Dr Mansel said. “They may not, because the hormones involved in the cancer are different, but until this is investigated in trials, we do not know what is the best treatment for them.”

Dr Mansel noted that men may also have to undergo radical surgery to remove cancerous breast tissue. Much is still unknown about male breast cancer, highlighting the importance of including this population in clinical trials.

"The cosmetic result after surgery is important for men too," Dr Mansel said. "At present, men with breast cancer often undergo radical surgery to remove all the cancer, but why should surgeons remove the nipple and the areola, if it's not necessary? Men feel self-conscious about how this looks because if they want to swim or go to the beach their chests are uncovered if they wear swimming trunks. They could benefit from more conservative surgery that preserves the nipple and areola."

There were approximately 2240 new cases of male breast cancer in 2013, resulting in 410 deaths in the United States, according to the release.

Since breast cancer affects each patient group differently, it is important to ensure that detailed outcomes are known, according to the session.

In Europe, several organizations are collaborating to analyze clinical data from male breast cancer patients. Additionally, the groups will determine the number of patients needed for clinical trials, to describe patterns of care, and to assess sample collection rate, according to the release.

"This collaborative approach will be needed to perform reliable clinical trials in men," Dr Mansel concluded.