Disparities in supportive care breast cancer clinical trial enrollment.

Abstract

e13786 Background: Supportive care clinical trials (CTs) are crucial for improving breast cancer (BC) survivorship, yet the representation of diverse demographic groups is insufficiently characterized. Methods: We conducted a systematic review of supportive care BC CTs registered on ClinicalTrials.gov with enrollment in the United States from 1/2010 to 9/2022. We excluded CTs that limited enrollment to specific demographic groups. One-sample proportion tests were used to assess racial, ethnic, and age representation across trials and by intervention and funding type using incidence data from the SEER registry. Results: A search of 2695 CTs identified 173 supportive care BC CTs. Of these, 128 (74%) reported race data, 99 (57%) reported ethnicity data, and 30 (17%) reported age data and were included. Demographic data across trials overall and by intervention and funding type are summarized in the table. Black (10.5% vs 11.6%, p < 0.001), Asian (4.3% vs 7.1%, p < 0.001), Hispanic (7.5% vs 12.7%, p < 0.001), and older adults (age > 65; 26.4% vs 44.4%, p < 0.001) were underrepresented across CTs overall. Asian, Hispanic, and older adults were underrepresented across all intervention subtypes and academic trials (p < 0.001). Hispanic and older adults were least represented in sexual health CTs. Black, Hispanic, and older adults were underrepresented in industry trials (p < 0.001). Conclusions: Black, Asian, Hispanic, and older adults are underrepresented in supportive care BC CTs, with adequate representation in only a minority of CT intervention/funding subtypes. Enhancing CT representation is necessary to improve health equity and generalizability of CTs. Black n(%) p-value (95% CI) Asian n(%) p-value (95% CI) Hispanic n(%) p-value (95% CI) Older adult n(%) p-value (95% CI) Overall 1764 (10.5%) <0.001 (0.10, 0.11) 716 (4.3%) <0.001 (0.04, 0.05) 1044 (7.5%) <0.001 (0.07, 0.08) 1134 (26.4%) <0.001 (0.25, 0.28) Diet and/or physical activity 471 (14.2%) <0.001 (0.13, 0.15) 41 (1.2%) <0.001 (0.01, 0.02) 226 (9.1%) <0.001 (0.08, 0.10) 5 (13.2%) <0.001 (0.05, 0.29) Symptom management 648 (8.6%) <0.001 (0.08, 0.09) 482 (6.4%) 0.011 (0.06, 0.07) 488 (7.8%) <0.001 (0.07, 0.08) 853 (27.5%) <0.001 (0.26, 0.29) Psycho-oncology 65 (7.2%) <0.001 (0.06, 0.09) 32 (3.5%) <0.001 (0.02, 0.05) 43 (6.3%) <0.001 (0.05, 0.08) 47 (21.2%) <0.001 (0.16, 0.27) CAM 137 (11.9%) 0.763 (0.10, 0.14) 46 (4.0%) <0.001 (0.03, 0.05) 81 (9.6%) 0.007 (0.08, 0.12) 13 (25.5%) 0.010 (0.15, 0.40) Education/Communication 373 (11.8%) 0.832 (0.11, 0.13) 79 (2.5%) <0.001 (0.02, 0.03) 177 (5.8%) <0.001 (0.05, 0.07) 216 (24.5%) <0.001 (0.22, 0.27) Sexual Health 53 (9.1%) 0.062 (0.07, 0.12) 27 (4.6%) 0.022 (0.03, 0.07) 25 (4.5%) <0.001 (0.03, 0.07) 0 (0.0%) <0.001 (0, 0.69) Academic funding 787 (12.8%) 0.005 (0.12, 0.14) 194 (3.1%) <0.001 (0.03, 0.04) 302 (6.5%) <0.001 (0.06, 0.07) 221 (30.5%) <0.001 (0.27, 0.34) Industry funding 435 (8.9%) <0.001 (0.08, 0.10) 361 (7.4%) 0.511 (0.07, 0.08) 352 (8.6%) <0.001 (0.08, 0.09) 464 (19.9%) <0.001 (0.18, 0.22)