89P Inclusion of racial and ethnic minorities in European breast cancer clinical trials

Abstract

Breast cancer outcome, drug response and adverse effects vary significantly among races in the USA, with Black women being the most disproportionately burdened. However, recent reports are pointing out a significant underrepresentation of minorities, especially Black and Hispanic, in American clinical trials. Among breast cancer trials leading to FDA drug approval, race was reported in 66.67% and 75.70% White, 15.52% Asian, 3.73% Hispanic and 2.10% Black patients were enrolled. There is no such analysis though about the situation in Europe. The aim of this study is to assess the representation of racial and ethnic minorities in the population enrolled in clinical trials for breast cancer pharmacological treatments in Europe. PubMed and ClinicalTrials databases were systematically reviewed for clinical trials on drug efficacy for breast cancer. Phase II and III clinical trials conducted exclusively in Europe with at least 250 participants and results published within 2010-2022 were included in this study. Descriptive statistics were applied. Ninety-seven clinical trials with a total of 113,045 patients were included. Patient race or ethnicity was reported in the patient demographics of only 10 (10.31%) articles. The lack of racial background data or ethnic diversity in their trial was acknowledged by three additional authors (3.1%). There were no substantial differences in race reporting trends depending on study phase (2/14 of phase II trials and 8/80 phase III trials). Among the 12,179 (10.77%) patients with available race data, 92.65% of patients were White/Caucasian, 1.08% were Asian and 0.88% Black. 3.20% identified as Hispanic/Latino (partially overlapping with the White population). Additionally, Europe’s largest ethnic minority, the Roma, is not mentioned in any of the included studies. Despite the proven correlation of race with breast cancer outcome, this study reports a concerningly low Black and Asian patient enrolment in European breast cancer trials compared to reports from corresponding analyses in the United States. These observations highlight the need for stricter guidelines for race and ethnicity reporting and inclusion in cancer clinical trials to match the diversity of the European population.