Exclusion of Male Patients in Breast Cancer Clinical Trials

[摘要] Men make up an estimated 1% of patients diagnosed with breast cancer in the United States each year (1). This analysis examined the inclusion and representation of men in breast cancer trials between January 1, 2000, and April 31, 2017. On ClinicalTrials.gov, 426 trials were identified and evaluated for inclusion and recruitment of male breast cancer patients. Of these, 277 trials (65%) excluded male breast cancer patients in their enrollment criteria. Overall, 0.42% of trial participants were men, with the lowest enrollment rates in hormonal and targeted therapy trials (0.1% and 0.1%, respectively). No men were included in the 70 trials studying neoadjuvant therapies. Future trials should take extra measures to recruit male participants to adequately understand the efficacy and safety of new regimens in this subset of patients.

[学科分类] 肿瘤学

[关键词] breast cancer;breast cancer, male