Background: Breast carcinoma prevention trials must recruit large cohorts of women who have an above-average risk of developing breast carcinoma. Recruitment for the Study of Tamoxifen and Raloxifene (STAR) trial required volunteers to complete a risk assessment questionnaire form (RAF). Women whose estimated risk of developing breast carcinoma in the next 5 years was > or = 1.67% based on the Gail model were invited to participate in STAR. Less than 4% of participants in the previously conducted P1 (tamoxifen vs. placebo) trial were minority women. We, therefore, studied barriers to minority participation in STAR among black, white, and Hispanic women who completed an RAF.
Methods: The authors analyzed the association of Gail model risk factors, education, and insurance with race/ethnicity using chi-square tests and two-sided P values. They developed logistic regression models of trial eligibility, controlling for the Gail model risk factors, education, and insurance status.
Results: Among 823 women who completed an RAF, white women were 10 times as likely as Hispanic women and 45 times as likely as black women to be eligible for STAR. Age at first birth (P = 0.04), having an affected first-degree relative (P < 0.0001), having had a biopsy (P < 0.0001), education (P < 0.0001), and insurance status (P < 0.0001) varied by race/ethnicity. All variables except insurance status were associated with eligibility when race was excluded from the model. In a model that included race/ethnicity, the same factors remained statistically significant.
Conclusions: These findings suggested that both the race/ethnicity adjustment and socioeconomic factors were barriers to eligibility for and contribute to low minority participation in breast cancer prevention trials.