The STAR (Study of Tamoxifen and Raloxifene) trial in West Virginia.

Female breast cancer is a major medical problem with significant public health ramifications. In 1999, more than 170,000 women were diagnosed with breast cancer in the U.S. and more than 40,000 died from this disease. The STAR trial will determine if raloxifene (Evista) is either more or less effective than tamoxifen (Nolvadex in reducing the incidence of invasive breast cancer in postmenopausal women who are at increased risk for the disease. A secondary goal is to compare raloxifene and tamoxifen with regard to their side effects. Approximately 22,000 postmenopausal women, 35 years of age or older, who are at increased risk for developing breast cancer will be randomly assigned in this double-blind trial to receive either 20 mg of tamoxifen plus a placebo or 60 mg of raloxifene plus a placebo, for five years. A substudy to evaluate the effect of raloxifene and tamoxifen therapy on study participants' quality-of-life will also be conducted.