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Abstract Background Tamoxifen and Aromatase inhibitors have been shown to be highly effective at reducing the incidence of ER-positive breast cancers in women at increased risk, but there are no approved agents for the risk reduction of ER-negative cancers. Evidence from observational and preclinical studies supports the study of statins for breast cancer risk reduction. Objective This study aimed to investigate the effects of Atorvastatin treatment on serum and tissue biomarkers in women at increased risk for breast cancer. Methods Women at increased risk for breast cancer were accrued prospectively at UTMDACC, Breast Medical Oncology High-Risk Clinic. The study was approved by the IRB and all participants signed informed consent. High risk was defined as having a previous history of DCIS, LCIS, or atypical hyperplasia, 5-year projected Gail risk 1. 67 %, or lifetime risk 20 % calculated by clinical models. Patients were randomized to no treatment (n=15) or daily 10mg (n=15), 20mg (n=14), or 40mg (n=16) Atorvastatin for 3 months. Fasting blood and breast tissue samples via fine needle aspiration (FNA) were collected at baseline and at study completion. Serum biomarkers were analyzed with ELISA (R Part 1 (Regular Abstracts) ; 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84 (6Suppl): Abstract nr 778.
Lanier et al. (Fri,) studied this question.