At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 19,747 enrolled
Drug / intervention
Raloxifene +1 moredrug
Likely dose
Raloxifene 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer
In Brief
A Phase 3 clinical trial evaluating Raloxifene and Tamoxifen for Breast Cancer. Completed, enrolled 19,747 participants across 516 sites in 3 countries.
Detailed Summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using raloxifene and tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. PURPOSE: Randomized double-blinded clinical trial to compare the effectiveness of raloxifene with that of tamoxifen in preventing breast cancer in postmenopausal women.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesCanada, Puerto Rico, United States
CollaboratorsNational Cancer Institute (NCI), Eli Lilly and Company, AstraZeneca
Timeline
Phase 3CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 1999
First PostedJan 2003
Primary CompletionDec 2005
Study CompletionAug 2012
TodayJul 2026
First PostedJan 27, 2003
Enrollment StartMay 1, 1999
Primary CompletionDec 1, 2005
Study CompletionAug 1, 2012
TodayJul 1, 2026
Enrollment to primary: 6.6 yearsPosted 23.4 years ago
Interventions
Raloxifenedrug
60 mg/day plus placebo for 5 years
Tamoxifendrug
20 mg/day plus placebo for 5 years