Addressing the clinical trial selection process to improve representation by African American patients with breast cancer in cancer clinical trials.
Authors: Kim Sarah , Uelk Madeleine , Fujiu Kathleen , Louthen Cathy Grace , Chervinko Nazzara , Patel Arpan , Robinson Patricia A. 
Published: June 2023

e18620

Background: Breast cancer (BC) is the most commonly diagnosed cancer in women. Despite overall improvements in BC outcomes, African American (AA) women are 41% more likely to die from BC. Causation of the disparity gap is multifactorial including less access to quality treatment, such as clinical trials (CTs). AA patients (pts) account for 12% of new BC cases in the United States, but constituted only 3% of the participants in the BC CTs that led to U.S. Food and Drug Administration approvals from 2008-2018. Lack of diverse participation on CTs does not allow the broad applicability of the results. As part of the "Bringing Quality Care Training to Komen’s African American Health Equity Initiative" in collaboration with ASCO, the Cardinal Bernardin Cancer Center (CBCC) examined the process for CT selection in order to increase opportunities for AA BC pts to participate in CTs. Methods: The CBCC team, comprised of social worker, breast program coordinator, medical oncology, and director of outreach developed process maps for CT selection, analyzed the BC CT content, and identified gaps relative to the pt population for industry and cooperative group CTs. The team surveyed faculty on reasons for not enrolling pts in CTs and assessed the demographics of the CT participants. Tumor registry identified BC pts by sex, race, ethnicity, phenotype and stage. Results: The CBCC treated 283 new BC cases in 2021. AA patients made up 15% (n = 22), 18% (n = 9), and 23% (n = 5) of stages I, II/III, and IV respectively. Fifteen percent were triple negative BC. Review of Velos demonstrated that CBCC enrolled 13 BC pts onto 2 BC drug CTs in 2021. We projected the need for CT selection based upon stage at diagnoses and tumor biology. We identified the following gaps in the breast oncology CT portfolio: non-competing neo-adjuvant CTs; adjuvant endocrine, HER2-targeted and triple negative CTs; and metastatic endocrine and HER2-targeted CTs. Faculty surveys demonstrated perceptions for not enrolling pts in CTs including low health literacy amongst pts, pt ineligibility, lack of institutional support, pt mistrust, language barriers, lack of time, and pt co-morbidities. Overall, pts were more likely to participate in cancer CTs if they were non-Hispanic white, privately insured, married and 60-69 years old. Conclusions: CTs lead to treatment advancements at faster rates with concurrent mortality reductions in the cancer population. It is necessary to increase representation in CT to address health equity. This requires intentional detail to the CT development and implementation process. Our study identified a number of factors, including structural, clinical, and attitudinal barriers on the part of the physician that impair enrollment. Institutions need to construct CT portfolios to ensure that it reflects the pt population that it serves. Further studies need to include the pt experience in CT participation.