Male breast cancer study highlights the need for pioneering clinical trials


Male breast cancer study highlights the need for pioneering clinical trials


In 2019, an estimated 268,000 cases of invasive breast cancer will be diagnosed in women. But each year about 1 percent of all breast cancer cases will appear in men too — which works out to around 2,000 new cases. Male breast cancer is now more common than it was 25 years ago but experts still simply don’t know the best way to treat breast cancer in men.

“We have never successfully completed a clinical trial that was designed to test therapies in men specifically,” said Kathryn Ruddy, M.D., a cancer scientist at the Mayo Clinic in Rochester. “So our management strategies are largely based on data from women.”

That means that there could be better ways to treat men with breast cancer – in fact, the treatment may already exist, with scientists needing to complete more research to discover what it is.

Ruddy is a co-author of a recently published study which investigated how male breast cancer has been treated in recent years. Her findings discovered that treatments continue to evolve over time, even with a lack of clinical trial data.

At the moment, treatments for male breast cancer are based on clinical trials done on women. More research is required that can be applied to men specifically.

The treatment was tracked of 10,873 men who were diagnosed with stage I-III breast cancer between 2004 and 2014. The typical age of onset was when they were around 64 years old, and the five-year survival rate was 79.1% in this analysis. Additional research suggests that men with breast cancer have a higher mortality rate than women – that analysis included 16,025 male and 1,800,708 female patients, and discovered that male patients had a 19% higher mortality rate from breast cancer than women.

The treatment choices used to treat men with breast cancer are not consistent. Options for treatment include chemotherapy, breast-conserving surgery, radiotherapy, and endocrine therapy. Endocrine therapy means that the patient is given a drug that helps to block estrogen receptors that may live on some kinds of tumours, and spur their growth if estrogen binds to them.

Endocrine treatment was reported to increase over the study period, suggesting that it is becoming more common to treat the condition this way – this conflicts with past research which showed only 77% of men with breast cancer received endocrine therapy despite having tumours that would likely have responded to the anti-estrogen drugs.

More broadly, anti-estrogen therapy is a case study that is in line with Ruddy’s larger point - we need more clinical trials to show just how well these types of interventions work in men.

“I hope that this draws attention to the need for clinical trials focused specifically on male breast cancer,” Ruddy explains. “I also hope that it helps us develop and target interventions to improve care and reduce health disparities.”


Future of male breast cancer treatment


Fortunately, more clinicals may begin to happen in the future, if slowly.

In August 2019, the FDA put forth a draft guidance calling for the inclusion of more men in breast cancer treatment trials. In that guidance, the agency notes that “This [historical] exclusion has resulted in limited FDA-approved treatment options for males with breast cancer.”

The guidance also argues for some basic changes, including the note that breast cancer treatment trials should “allow for inclusion of both males and females” and investigate how findings for women could also be applied to men.

However, other doctors argue that, while clinical trials are necessary, they are not sufficient alone. Another prudent step would be to spread the word that men can get breast cancer to begin with.

Fatima Cardoso, M.D., the director of the Breast Unit at Champalimaud Clinical Center in Portugal told the New York Times “Some men are not even aware they have breasts and not aware they can have breast cancer. We need a lot of education to remind men they have breasts, too, and should check them.”

Overall, Ruddy’s work adds to a growing list of studies that are echoing the need for more research into male breast cancer. And if the draft guidance is any indication, their work could be about to pay off.

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