Patient-Reported Symptoms and Quality of Life During Treatment With Tamoxifen or Raloxifene for Breast Cancer Prevention

Abstract

The National Surgical Adjuvant Breast and Bowel Project (NSABP) Study of Tamoxifen and Raloxifene (STAR) was a multicenter, double-blind, randomized phase 3 prevention trial designed to evaluate the relative efficacy of raloxifene (60 mg/d for 5 years) compared with tamoxifen (20 mg/d for 5 years) in reducing the incidence of invasive breast cancer in high-risk postmenopausal women. In addition, it was hypothesized that raloxifene would have a better safety profile with respect to uterine cancer and a number of patient-reported symptoms and would provide a potential alternative to tamoxifen in the prevention of breast cancer in postmenopausal women. Therefore, measurement of patient-reported outcomes was an important secondary objective of the STAR trial.