Exclusion of Men from Randomized Phase III Breast Cancer Clinical Trials.

Exclusion of Men from Randomized Phase III Breast Cancer Clinical Trials.
Oncologist. 2020 Apr 09;:
Authors: Corrigan KL, Mainwaring W, Miller AB, Lin TA, Jethanandani A, Espinoza AF, Piotrowski M, Fuller CD, Stauder MC, Shaitelman SF, Perkins GH, Woodward WA, Giordano SH, Smith BD, Ludmir EB
Abstract
Male breast cancer treatment regimens are often extrapolated from female-based studies because of a paucity of literature analyzing male breast cancer. Using ClinicalTrials.gov, we analyzed breast cancer randomized clinical trials (RCTs) to determine which factors were associated with male-gender inclusion. Of 131 breast cancer RCTs identified, male patients represented 0.087% of the total study population, which is significantly less than the proportion of male patients with breast cancer in the U.S. (0.95%; p < .001). Twenty-seven trials included male patients (20.6%). Lower rates of male inclusion were seen in trials that randomized or mandated hormone therapy as part of the trial protocol compared with trials that did not randomize or mandate endocrine therapy (2.5% vs. 30.5% male inclusion; p < .001). It is imperative for breast cancer clinical trials to include men when allowable in order to improve generalizability and treatment decisions in male patients with breast cancer.
PMID: 32272505 [PubMed - as supplied by publisher]

Source: The Oncologist - April 8, 2020 Category: Cancer & Oncology Authors: Corrigan KL, Mainwaring W, Miller AB, Lin TA, Jethanandani A, Espinoza AF, Piotrowski M, Fuller CD, Stauder MC, Shaitelman SF, Perkins GH, Woodward WA, Giordano SH, Smith BD, Ludmir EB Tags: Oncologist Source Type: research