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Breast

E18: Clinical Trial Eligibility and Enrollment among Breast Cancer Patients at an Academic NCI designated Cancer Center: Implications for understanding trial disparities

Introduction: Clinical trial participation lacks diverse representation, hindering generalizability of results and exacerbating pre-existing disparities in clinical outcomes. This analysis explored associations between breast cancer patient demographics and clinical trial eligibility and enrollment.

Methods: This retrospective cohort study included patients with breast cancer who were screened for institutional therapeutic clinical trials. Trial eligibility and enrollment were determined via the provider for trials available and open at our institution.  Patient demographics were abstracted from the electronic medical record, including age at first trial screen, marital status, race, and neighborhood. Address determined rurality of patient residence using Rural-Urban Commuting Area codes and neighborhood disadvantage using Area Deprivation Index (ADI). Likelihood of trial eligibility and enrollment by race, rurality, and neighborhood disadvantage were evaluated using risk ratios (RR) and 95% confidence intervals (CIs) from covariate-adjusted, modified Poisson regression models.

Results: Of 211 patients screened for therapeutic trials, mean age was 56 (SD 11.9), 32% were Black or other race, 24% lived in highly disadvantaged areas, and 17% lived in rural areas. Most patients were screened for one trial (87%), while 10% screened for two or more trials. Overall 54% of breast cancer patients were eligible for clinical trials and 58% enrolled.  Figure 1 demonstrates similar likelihoods of trial eligibility and enrollment by race and rurality. Patients living in highly disadvantaged areas had 22% lower likelihood of trial eligibility (RR 0.78, 95% CI 0.53-1.09), yet 20% higher likelihood of trial enrollment (RR 1.20, 95% CI 0.83-1.74).

Conclusions: Greater than 50% of eligible patients, even based on race, rurality, and ADI enrolled in therapeutic clinical trials, which is higher than national average. Moreover, there was significant trend in increased clinical trial enrollment among patients of higher ADI, another contrast to national trends.  Currently, we are exploring patient factors in trial enrollment decision making via semi-structured patient interviews.

Learning Objectives:

  • Describe the cascade from eligibility to enrollment for breast cancer therapeutic clinical trials.
  • Describe eligibility and enrollment patterns for breast cancer therapeutic clinical trials.
  • Describe the magnitude of demographic disparities present at multiple steps in the clinical trial cascade.