More Men Needed in Breast Cancer Clinical Trials
Breast cancer is rare in men. About one percent of all breast cancer diagnoses are in men. However, when men are diagnosed, their cancer tends to be at a later stage. And a recent JAMA Oncology study found that, overall, men are more likely than women to die of their disease.
Most drugs used to treat breast cancer have not been tested in men. In April, when the FDA approved Ibrance® for men with metastatic breast cancer, it used real-world data collected on off-label use, not data from a clinical trial.
The FDA wants to change this. In September, it issued draft guidelines that encourage researchers to include men with breast cancer in their clinical trials to improve drug development and access.
Below you can learn more about the FDA’s statement as well as read the FDA’s draft guidelines: “Male Breast Cancer: Developing Drugs for Treatment.”
We’ve also included links to the JAMA Oncology article on breast cancer mortality along with an article on the FDA’s approval of Ibrance® using real-world data.
You can find more information for men with metastatic breast cancer on the Male Breast Cancer Coalition‘s website.
- FDA: FDA Encourages Inclusion of Male Patients in Breast Cancer Clinical Trials
- FDA: FDA Guidance on Male Breast Cancer: Developing Drugs for Treatment
- The New York Times: Who’s Missing from Breast Cancer Trials? Men, Says the FDA
- MedScape: FDA Wants Men in Breast Cancer Clinical Trials
- JAMA Oncology: Overall Mortality After Breast Cancer Diagnosis in Men vs. Women
- Cancer Today: A New Use for Patient Data
- The Male Breast Cancer Coalition: The Male Breast Cancer Coalition