Enrollment onto breast cancer therapeutic clinical trials: a tertiary cancer center experience

Background: Advances in breast cancer prevention, diagnosis, and treatment are in part the result of patient involvement in clinical trials. Despite increases in new clinical research initiatives and trials open to accrual, only 2-3% of women with breast cancer enroll. There is a need to identify the barriers interfering patient accrual.

Methods: Data were extracted from patients with breast cancer seen for treatment in 2009 retrospectively. Descriptive analysis of patient demographic on enrollment were performed using logistic regression analyses.

Results: Of 418 patients evaluated for treatment, 163 had a trial available; 138 of these were eligible. Eighty (58%) participated in a clinical trial; the remainder declined (24%) or were not presented for a trial by their treating physicians (76%). Age, preferred language, marital status, family history, or race/ethnicity did not predict for enrollment on a therapeutic clinical trial. Patients with stage II or III breast cancer were more likely to be enrolled on a trial compared to patients with stage 0 or I (odds ratio 2.89, 9.17; p=.02, .0005 respectively).

Conclusions: Enrollment of breast cancer patients on therapeutic clinical trials was relatively high (58% eligible, 19% overall). Prospective studies observing breast cancer stage, clinical trial design, and inclusion of community based physician practices would add breadth to the understanding of poor accrual to breast cancer clinical trials.