6/29/23, 11:45 PM STAR Pathway Feedback Search Clinical Topics Home Studies STAR STAR Trial question What is the effect of raloxifene in postmenopausal women with an increased risk of invasive breast cancer? Study design Multi-center Double blinded RCT Population 19747 female patients Inclusion criteria: postmenopausal women with a mean age of 58.5 years who have an increased 5-year breast cancer risk Key exclusion criteria: age < 35 years or premenopausal; receipt of tamoxifen, raloxifene, hormone therapy, oral contraceptives, or androgens for at least the previous 3 months; history of stroke, PE, or deep vein thrombosis uncontrolled AF, uncontrolled diabetes, or uncontrolled hypertension Interventions N=9745 raloxifene (60 mg/day for a maximum of 5 years) N=9726 tamoxifen (20 mg/day PO for a maximum of 5 years) Primary outcome Invasive breast cancer 0.4 % 0.44 0.43 0.3 % 0.2 % 0.1 % No significant difference 0.0 % Raloxifene Tamoxifen No significant difference in invasive breast cancer (0.44% vs. 0.43%; RR 1.02, 95% CI 0.82 to 1.28) Secondary outcomes https://web.pathway.md/studies/rec6TOwKD2ksvHU85 1/2 6/29/23, 11:45 PM STAR Pathway No significant difference in noninvasive breast cancer (0.21% vs. 0.15%; RR 1.4, 95% CI 0.98 to 2) No significant difference in uterine cancer (0.13% vs. 0.2%; RR 0.62, 95% CI 0.35 to 1.08) Borderline significant decrease in thromboembolic events (0.26% vs. 0.37%; RR 0.7, 95% CI 0.54 to 0.91) Safety outcomes No significant differences in deaths, osteoporotic fractures, stroke, ischemic heart disease. Significant differences in cataracts (0.97% vs. 1.23%), cataract surgeries (0.66% vs. 0.80%). Conclusion In postmenopausal women with a mean age of 58.5 years who have an increased 5-year breast cancer risk, raloxifene was not superior to tamoxifen with respect to invasive breast cancer. Reference Vogel VG, Costantino JP, Wickerham DL et al. Effects of tamoxifen vs raloxifene on the risk of developing invasive breast cancer and other disease outcomes: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial. JAMA. 2006 Jun 21;295(23):2727-41. Open reference URL https://web.pathway.md/studies/rec6TOwKD2ksvHU85 2/2