Nearly 7 years ago I did an analysis of clinical trials and found that 32% of trials allowed both male and female patients to enroll, as I wrote on this site and in a publication, “Male Breast Cancer: Opportunities for Research and Clinical Trials“.
Today I repeated the search, this time focusing on actively recruiting trials, and found that men are eligible, alongside women, for 40% of trials!
Here is a simple visualization, also breaking down the numbers by phase and type of intervention:
(Back in 2013 I looked at all trials to get the 32% – when I looked at actively recruiting trials, it was 30%, so the increase to 40% is actually larger.)
This increase of 10% in eligibility is great news for men with breast cancer.
We have to bear in mind that the biology of female and male breast cancer likely mean that for some trials including men does not make sense, biologically. Most men have ductal carcinoma that is hormone-driven, for example, so if the trial focuses on inflammatory breast cancer it may well not be open to men.
As I wrote in the Breast Disease Quarterly piece linked above, my request to clinical trial investigators is to think of the default to be including men (i.e. “both genders”) or to provide a reason for not including men.
I am not sure what the percentage should be, if men were included everywhere it makes sense. Clearly not 100%, but perhaps more than 40%?
For now: my deep gratitude to all investigators who include men in their breast cancer clinical trials, where it makes sense. Thank you!
My request: please keep going.