The study of tamoxifen and raloxifene (STAR): First report of patient-reported outcomes (PROs) from the NSABP P-2 Breast Cancer Prevention Study

LBA561 Background: STAR is a double-blind, randomized phase III prevention trial designed to evaluate the relative efficacy of raloxifene (R) compared to tamoxifen (T) in reducing the incidence of invasive breast cancer in high-risk postmenopausal women. In addition to standard safety monitoring, PROs were measured for quality of life (QOL) and symptoms (SXs). Methods: QOL was measured with the MOS SF-36, the CES-D, and the MOS Sexual Activity Questionnaire. SXs were measured using a modified checklist (SCL) from the NSABP P-1 BCPT. Primary endpoints were the SF-36 physical (PCS) and mental (MCS) component scales. A sample size of 1,670 provided statistical power of at least 0.8 (two-tailed test, alpha = .05). The QOL study was open to accrual at selected sites between 1/4/2000 and 5/31/2001, with questionnaires administered at baseline (pre-treatment), q 6 mos until 60 mos, and at 72 mos. SCL data were collected on all STAR participants. Longitudinal analyses used mixed effects modeling for the PCS, MCS,...