Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00003906 | Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer in Postmenopausal Women | PHASE3 | COMPLETED | 19,747 | — | — | May 1, 1999 | Aug 1, 2012 | Oct 6, 2015 | 516 | United States, Canada +1 |
Determine which of the following is true: 1. compared to tamoxifen, raloxifene significantly reduces the incidence rate of invasive breast cancer; 2. compared to raloxifene, tamoxifen significantly reduces the incidence rate of invasive breast cancer; or 3. the statistical superiority of one of the treatments cannot be demonstrated and the choice of therapy should be based on benefit/risk considerations.
| Arm | Type | Description |
|---|---|---|
| Group 1 | ACTIVE_COMPARATOR | Tamoxifen and placebo |
| Group 2 | EXPERIMENTAL | Raloxifene and Placebo |
| Name | Type | Description |
|---|---|---|
| Raloxifene | DRUG | 60 mg/day plus placebo for 5 years |
| Tamoxifen | DRUG | 20 mg/day plus placebo for 5 years |
DISEASE CHARACTERISTICS: * Postmenopausal women at increased risk for developing invasive breast cancer, who meet one of the following criteria: * At least 12 months since spontaneous menstrual bleeding * Prior documented hysterectomy and bilateral salpingo-oophorectomy * At least 55 years o...