STAR
Trial question
What is the effect of raloxifene in postmenopausal patients with an increased risk of invasive breast cancer?
Study design
Multi-center
Double blinded
RCT
Population
19747 female patients.
Inclusion criteria: postmenopausal female patients 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 DVT 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
0.44%
0.43%
0.4 %
0.3 %
0.2 %
0.1 %
0.0 %
Raloxifene
Tamoxifen
No significant
difference ↔
No significant difference in invasive breast cancer (0.44% vs. 0.43%; RR 1.02, 95% CI 0.82 to 1.28).
Secondary outcomes
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 female patients 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.
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