68 Background: Accrual of racial and ethnic minority patients (pts) to clinical trials has been an ongoing challenge in research. Barriers exist at many levels of engagement including trial availability, screening biases, strict enrollment criteria, and structural racism. Lack of trial diversity has led to less generalizable medical evidence, suboptimal data for toxicity and efficacy of cancer treatments, poorer outcomes and continued mistrust by communities of color in research processes that exclude or marginalize them. Site factors and study design strategies associated with successful recruitment of diverse study populations are understudied. Methods: Alliance A191901 is an RCT testing combinations of text and telephone support to promote endocrine therapy adherence among breast cancer survivors. It oversamples Black participants and those < 50 years at thresholds of 30% each. Administrative enrollment data was used to track and describe monthly accrual trajectory by race among the initial 50% of participants (n = 590) and to examine associations between % Black participants accrued and accruing site characteristics, including site type, geographic region, % Black population in the site’s zip code and volume of pts by race accrued to recent (2018-2019) Alliance trials, using χ2 tests. We also examined patterns of Black participant accrual before and after closure of the A191901 study to non-Black participants. Results: At 50% accrual, 124 sites had enrolled at least 1 participant. Among 590 participants, 9.7% were Black and 22.5% were < 50 years. Neither site type nor volume was associated with % Black participants recruited. Sites in the South recruited higher proportions of Blacks (19.0% vs 5.6% for Midwest, the lowest region, p < 0.001). Neighborhood racial composition was positively associated with accrual of Black participants (17.2% at sites from highest Black composition vs. 2.3% in lowest, p < 0.001). Recruitment trajectories of Black participants consistently lagged those of non-Black participants in the first half of the study; however, Black participants recruited per month numerically increased after the study reached target accrual of non-Blacks and closed to non-Black participants. Conclusions: Sites in neighborhoods and geographic regions with larger Black populations recruited higher proportions of Black participants, but site type and volume were not associated with recruitment of Black participants. Closure of non-Black study strata based on predetermined accrual targets may positively impact recruitment trajectories of Black participants, but further study is needed. Site selection based on neighborhood composition and geography may be an appropriate tool for increasing trial diversity. Support: UG1CA189823. Clinical trial information: NCT04379570.
Background: Black and younger women have poorer breast cancer outcomes. Using a diverse population-based study, we examined the role of biology as measured by genomic assays in outcome disparity among clinically HR+/HER2- women. Methods: Data and biospecimens from the Carolina Breast Cancer Study (CBCS, including 2,103 non-metastatic, invasive breast cancers) were used to perform RNA-based classification according to molecular subtype and research versions of known prognostic assays, the 21-gene Recurrence Score (RS) and the PAM50-based Risk of Recurrence (ROR-PT) score. Prevalence odds ratios (PORs) and 95% confidence intervals (CIs) for subtype by race and age were estimated. Results: Black women had higher frequency of Luminal B [POR (95% CI): 2.08 (1.60, 2.71)], HER2-enriched [POR (95% CI): 2.01 (1.45, 2.79)], and Basal-like tumors [POR (95% CI): 3.51 (2.81, 4.40)] compared to non-Black women. Similarly, younger (< 50 years) women had higher frequency of Luminal B [POR (95% CI): 1.57 (1.21, 2.04)], HER2-enriched [POR (95% CI): 2.03 (1.46, 2.82)], and Basal-like tumors [POR (95% CI): 2.40 (1.92, 3.01)]. Additionally, within clinically-defined HR+/HER2- tumors, Black women had higher frequency of high ROR-PT among younger women [POR (95% CI): 2.88 (1.19, 6.97)], but this association was attenuated among older women [POR (95% CI): 1.99 (0.84, 4.71)]. Race was not significantly associated with the 21-gene RS among younger or older women. Conclusion: While Black and younger women with clinically-defined HR+/HER2- often have higher burden of non-Luminal/high genomic risk tumors, PAM50 and 21-gene assays show different demographic patterns and heterogeneity within age- and race-defined groups, underscoring the value of genomic testing in understanding outcome disparities. Citation Format: Sanah Vohra, Sarah Van Alsten, Joannie M. Ivory, Alina Hamilton, Xiaohua Gao, Erin Kirk, Joseph Nsonwu-Farley, Ebonee Butler, Brianna Taffe, Charles M. Perou, Lisa Carey, Melissa Troester. PAM50 and 21-gene recurrence scores in younger and Black women with breast cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr PD1-08.
1055 Background: Gene expression profiling (GEP) is used to classify breast cancer (BC) into four intrinsic subtypes: Luminal A (LumA), Luminal B (LumB), HER2-Enriched, and Basal-like. Non-LumA subtypes are associated with poorer outcomes. Studies in early BC show that hormone receptor-positive (HR+)/HER2-negative (HER2-) tumors have a higher frequency of non-LumA subtypes in Black and younger (<50) women. Similarly, triple negative BC, which carries the poorest prognosis and is mostly Basal-like, are overrepresented in Black and younger women. These variations in intrinsic subtype contribute to outcomes disparities. The extent to which these racial and age differences in subtypes and mortality occur in metastatic breast cancer (MBC) is unknown. Methods: HARMONY (NCT03769415) is a prospective clinical trial in patients with newly diagnosed MBC. Bulk tumor GEP (PAM50 intrinsic subtyping) is performed on primary and metastatic tumors. A primary objective is to determine the extent and treatment implications of molecular discordance (defined a priori as treatment differences by intrinsic subtype compared to clinical subtype); other endpoints to be reported later include GEP comparisons between primary and metastatic samples. Here we examine differences in a) intrinsic subtype and b) treatment patterns in MBC by race and age. Results: At the time of analysis, the study had accrued 220 participants. Mean age was 58, 24% were Black women. Sixty-five percent had HR+/HER2- MBC, 14% HER2-positive, and 21% triple negative. Unlike in early BC, LumB exceeded LumA (LumA 27%, LumB 35%, HER2-Enriched 12%, Basal-like 25%). Similar to early BC, subtype varied by race and age with more non-LumA subtypes in young and Black women. Discordance between intrinsic and clinical subtype was seen in 24% of Black, 20% of White women, in 29% of younger and 18% of older women. Treatment patterns also differed by race and age, where a higher percentage of younger Black women received first-line chemotherapy compared to younger White women overall (45% vs. 10%, p=0.0025), and in HR+/HER2- disease (33% vs 8.7%, p=>0.05). No difference was seen in older women (24% vs 17%, p=0.44). Median progression free survival was worst in younger Black women compared to all other participants (5.4 vs 19.5 months, p=0.027), which may be driven by clinical subtype. Conclusions: Intrinsic subtype of tumors in a metastatic population has a different distribution by race and age than early BC, with more poor-prognosis non-LumA subtypes, and approximately 1 in 5 have discordance between clinical and molecular subtype, which may be therapeutically relevant. Clinical trial information: NCT03769415 . [Table: see text]
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