Racial and Ethnic Disparities Among Patients Enrolled in Breast Reconstruction-Related Clinical Trials

Breast reconstruction clinical trials that reflect the racial and ethnic makeup of breast cancer disease burden are fundamental in improving breast reconstruction accessibility and outcomes. We aim to evaluate race and ethnicity reporting in breast reconstruction-related clinical trials (BRRCTs) and determine whether reported race and ethnicity of enrollees aligns with their breast cancer incidence rates in the general US population.

All completed, US-based BRRCTs were retrospectively reviewed via ClinicalTrials.gov in February 2024. Age, race, ethnicity, and BRRCT funding source were recorded. BRRCT enrollment rates of racial and ethnic groups were compared to their expected representation rates, calculated using breast cancer incidence rate. Descriptive statistics and univariate analyses were performed.

Twenty-five studies representing 2603 patients were included. The mean age of enrollees was 49.4 ± 2.2 years. Seven (28%) reported enrollees' race, and 5 (20%) reported both race and ethnicity. Most enrollees were White (90.8%), followed by Black (3.5%), Asian (1.5%), and American Indian/Alaska Native (AI/AN) (0.1%). Fewer enrollees identified as Hispanic/Latino than non-Hispanic/Latino (7.6% vs 91.5%, P < 0.01). Observed enrollment rates of minority groups were lower than their respective expected representation rates (Black: 3.5% vs 24.9%, P < 0.01; Asian: 1.5% vs 23.9%, P < 0.01; AI/AN: 0.1% vs 24.9%, P < 0.01; Hispanic/Latino: 7.6% vs 45.2%, P < 0.01). Conversely, White enrollees were overrepresented when compared to the group's overall breast cancer burden (90.8% vs 26.4%; P < 0.01).

Over 70% of BRRCTs did not report the race or ethnicity of enrollees. When reported, racial and ethnic minorities were significantly underrepresented in BRRCTs. More diligent reporting and proactive initiatives to increase recruitment of minority groups in clinical trials are needed to strengthen the validity of BRRCTs.