Breast cancer is the most prevalent female cancer worldwide with known correlations between the race and tumor characteristics of the patients and prognosis. International and US-based studies, however, have reported a disproportionate representation of Black and Hispanic patients in clinical trials. This is the first study assessing race and ethnicity reporting trends and inclusion in European breast cancer trials. The PubMed and ClinicalTrials.gov databases were systematically searched for trials on breast cancer treatment conducted exclusively in Europe between 2010 and 2022. Of the 97 identified trials, race was reported in 10.31%. Multinational participation, but not the study size or trial phase, was significantly associated with higher race reporting trends. These 10 trials featured a White-predominant population, with 1.08% Asian and 0.88% Black patients included. The acquisition of the race and ethnicity data of patients in European trials is lower compared to the U.S. or worldwide studies and does not permit extensive analysis of minority participation. In a limited analysis, the low rates of minority participation are concerning, based on population-based data on minorities in select European countries. These observations should encourage race reporting practices in European breast cancer trials and adequate minority participation to support the generalizability of the results of the studies and promote healthcare equity.
乳腺癌是全球女性最常见的癌症,已知患者种族与肿瘤特征及预后之间存在相关性。然而,国际及美国的研究报告显示,黑人和西班牙裔患者在临床试验中的代表性不足。本研究首次评估了欧洲乳腺癌临床试验中种族与民族信息的报告趋势及纳入情况。通过系统检索PubMed和ClinicalTrials.gov数据库,筛选出2010年至2022年间完全在欧洲进行的乳腺癌治疗试验。在97项已确定的试验中,仅有10.31%报告了种族信息。多国参与(而非研究规模或试验阶段)与更高的种族报告率显著相关。这10项试验以白人患者为主,其中亚裔患者占1.08%,黑人患者占0.88%。与美国或全球性研究相比,欧洲试验中患者种族与民族数据的获取率较低,无法对少数族裔参与情况进行深入分析。基于部分欧洲国家的少数族裔人口数据,有限的初步分析显示少数族裔参与率偏低的问题值得关注。这些发现应促使欧洲乳腺癌临床试验改进种族信息报告规范,并确保少数族裔的充分参与,以支持研究结果的普适性并促进医疗公平。
Racial and Ethnic Disparities in European Breast Cancer Clinical Trials