Abstract PO3-09-10: Minority participation in breast cancer therapeutic trials at an NCI-CCC affiliated safety-net system: Advancing equity in clinical research
Authors: Qureshi Nasir , Robles Fabian 
Published: May 2024

Authors: Nasir Qureshi, MBBS Fabian Robles, MS Mai Badran, MBBS Nisha Unni, MD Hsiao C Li, MD Samira Syed, MD Glenda Delgado-Ramos, MD Sangeetha Reddy, MD Heather McArthur, MD Navid Sadeghi, MD Title: Minority participation in breast cancer therapeutic trials at an NCI-CCC affiliated safety-net system: Advancing equity in clinical research. Introduction: Participation of under-represented minorities (URMs) in clinical trials enhances the generalizability of the findings and can also improve clinical outcomes. Multiple factors, such as access, language barrier, distrust, and misconceptions, negatively impact URM enrollments in cancer clinical trials. Here we describe our approach to increase participation of breast cancer URMs in therapeutic trials at an academic-affiliated safety-net system. Methods: Parkland Health (PH) is a large safety-net system in Dallas County, Texas, and is affiliated with the NCI-CCC designated Harold C. Simmons Comprehensive Cancer Center (SCCC) at UT Southwestern. A dedicated team of SCCC research coordinators support the clinical trial operations at PH. In 2020, several steps were taken to increase access and enrollment of URMs in breast cancer trials at PH including review and optimization of the trial portfolio (more trials in curative intent setting), proactive screening, increasing provider awareness, and addition of a bilingual (English/Spanish) patient navigator to the research team. Data for 2018-2019 (pre-intervention) and 2021-2022 (post-intervention) is presented here. Data for 2020 is excluded due to the impact of COVID-19 pandemic on trial operations. Results: Racial and ethnic minorities composed the majority of breast cancer patients at PH (52% Hispanics, 32% Blacks). Ten percent of new patients at PH presented with metastatic disease. In 2018-2019, PH's portfolio included 13 therapeutic trials, 5 of which (38%) were in metastatic setting and 3 required a biomarker. A total of 47 breast cancer patients were enrolled in 11 therapeutic trials at PH, accounting for an average annual accrual rate of 6.1% (7.6% in 2018 and 4.5% in 2019). Accrual to trials in the metastatic setting accounted for 11% (5/47) of enrollments. Two trials in the metastatic setting had zero accruals. In 2021-2022, 16 trials were open at PH, including 7 cooperative group, 4 industry-sponsored (ISTs), and 5 Investigator-Initiated trials (IITs). Five trials (31%) were in metastatic setting and 4 required a genomic biomarker. A total of 87 patients were enrolled in 2021-22, representing an 85% increase in the accruals over the baseline (2018-2019). The annual accrual rates for 2021 and 2022 were 10.5% (43/409) and 10.4% (44/423), respectively. In 2021-22, 63 were enrolled in cooperative group studies, 20 in IITs, and 4 in ISTs. Accrual to trials in the metastatic setting accounted for 6% (5/87) of enrollments. Two studies had zero accruals. The majority of the trial participants (77/87; 89%) belonged to URMs (64 Hispanic, 13 Black). Overall participation rate was 67% (87/129) and was significantly higher in Hispanics compared to Blacks (77% vs 41% - p &lt; 0.001). Among Black patients who declined participation, 42% (8/19) cited lack of interest as the reason, which may reflect distrust or misperceptions regarding clinical trials. Conclusions: The collaboration between academic centers and safety-net systems provides a unique opportunity to promote equity in clinical trials by increasing access and enrollment of URMs. Developing a balanced portfolio that matches the patient population, enhanced screening, and incorporating clinical trial patient navigation at our institution resulted in a sustained increase in the number of URM trial participants. Given the lower participation rate among eligible Black patients, we aim to expand our clinical trial navigation program to better address the distrust and misperceptions regarding clinical trials, as a strategy to further improve trial participation at our institution.

Citation Format: Nasir Qureshi, Fabian Robles. Minority participation in breast cancer therapeutic trials at an NCI-CCC affiliated safety-net system: Advancing equity in clinical research [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-09-10.