NSABP STAR — Study of Tamoxifen and Raloxifene (STAR) P-2 Trial: Effects of Tamoxifen vs Raloxifene on the Risk of Developing Invasive Breast Cancer and Other Disease Outcomes

Phase 3 · 2006 · Breast Cancer

Design

Randomized, double-blind trial comparing raloxifene 60 mg/day versus tamoxifen 20 mg/day for 5 years for breast cancer risk reduction.

Population

Postmenopausal women at increased 5-year risk of breast cancer (Gail model risk >=1.66%).

Primary Endpoint

Incidence of invasive breast cancer

Key Result

Raloxifene was as effective as tamoxifen (RR 1.02; 163 vs 168 invasive cancers) with fewer uterine cancers (RR 0.62) and thromboembolic events (RR 0.70).

Guideline Impact

Raloxifene included in ASCO/USPSTF breast cancer risk-reduction guidance