本研究旨在确定在平等准入环境下不同背景患者的乳腺癌临床试验（CCT）入组模式，并评估导致低社会经济地位（SES）患者临床试验应计率低的因素。我们对 Dan L. Duncan 综合癌症中心 2015 年 5 月至 2021 年 9 月期间新患者的前瞻性维护数据库进行了回顾性审查，其中包括 3043 名接受乳腺 CCT 筛查的患者。我们比较了两个患者群体之间的 CCT 可用性、资格和登记率：史密斯诊所 (Smith Clinic) 的大多数患者社会经济地位较低且没有保险，而贝勒圣卢克医疗中心 (BSLMC) 的患者主要是有保险的高收入患者。我们进行逻辑回归来评估年龄、临床、种族、试验类型和主要语言的差异是否可能是 CCT 入组差异的基础。更多患者符合史密斯诊所 CCT 条件（53.7% vs 44.7%，p<0.001）。然而，与 BSLMC 相比，Smith Clinic 患者更有可能拒绝 CCT 入组（下降 61.3% vs 39.4%，p<0.001）。在多变量分析中，黑人患者整体拒绝 CCT 的比例显着较高（OR = 0.26，95% CI 0.12-0.56，p < 0.001），而仅 BSLMC（OR = 0.20，95% CI 0.060-0.60，p = 0.006） 。我们的数据表明，假设平等机会将导致消除 CCT 差异可能过于简单化。使 CCT 多样化的努力必须包括考虑结构和制度不平等以及社会需求。© 2024。作者。

This study was designed to determine the enrollment patterns in breast cancer clinical trials (CCTs) of patients with diverse backgrounds in an equal access setting and to evaluate the factors contributing to low rates of clinical trial accrual in patients of low socioeconomic status (SES). We performed a retrospective review of a prospectively maintained database of new patients seen at the Dan L. Duncan Comprehensive Cancer Center dating from 5/2015 to 9/2021, which included 3043 patients screened for breast CCTs. We compared the rate of CCT availability, eligibility, and enrollment between two patient populations: Smith Clinic, where most patients are of low SES and uninsured, and Baylor St. Luke's Medical Center (BSLMC) with mostly predominantly insured, higher income patients. We performed logistic regression to evaluate whether differences in age, clinic, race, trial type, and primary language may be underlying the differences in CCT enrollment. More patients were eligible for CCTs at Smith Clinic (53.7% vs 44.7%, p < 0.001). However, Smith Clinic patients were more likely to decline CCT enrollment compared to BSLMC (61.3% declined vs 39.4%, p < 0.001). On multivariate analysis, Black patients had a significantly higher rate of CCT refusal overall (OR = 0.26, 95% CI 0.12-0.56, p < 0.001) and BSLMC only (OR = 0.20, 95% CI 0.060-0.60, p = 0.006). Our data shows that it is likely an oversimplification to assume that equal access will lead to the elimination of CCT disparities. Efforts to diversify CCTs must include consideration of structural and institutional inequities as well as social needs.© 2024. The Author(s).