Work

Exclusion of Men from Randomized Phase III Breast Cancer Clinical Trials

Year: 2020

Type: article

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. 28.6% 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.

Source: The Oncologist

DOI: 10.1634/theoncologist.2019-0871

Authors: Kelsey L. Corrigan, Walker Mainwaring, Austin B. Miller, Timothy A. Lin, Amit Jethanandani, Andres F. Espinoza, Matt Piotrowski, C. David Fuller, Michael C. Stauder, Simona F. Shaitelman, George H. Perkins, Wendy A. Woodward, Sharon H. Giordano, Benjamin D. Smith, Ethan B. Ludmir

Institutions: The University of Texas MD Anderson Cancer Center, Baylor College of Medicine, Johns Hopkins University, University of Tennessee Health Science Center

Language: English

Topic: Male Breast Health Studies

Subfield: Public Health, Environmental and Occupational Health

Field: Medicine

Domain: Health Sciences

SDGs: Good health and well-being, Reduced inequalities

Open Access status: bronze

OpenAlex ID: W3016128754

FWCI: 1.39

Cites: 9

Cited by: 24

Related to: 10