Letrozole in Preventing Breast Cancer in Postmenopausal Women
Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Letrozole may be effective in preventing the development or recurrence of breast cancer in postmenopausal women who are at increased risk of developing breast cancer because of elevated estradiol levels. PURPOSE: This randomized phase II trial is studying how well letrozole works in preventing breast cancer in postmenopausal women with elevated estradiol levels.
Timeline
- Start
- 2002-02
- Primary completion
- 2008-08
- Completion
- 2013-03
Outcome
Missed primary endpoint
registry MEDIAN Letrozole: -0.036 (-0.092 to 0.272) g/cm^2 MEDIAN Placebo: -0.021 (-0.180 to 0.064) g/cm^2 analysis (superiority or other test); Letrozole vs Placebo; p = 0.15 NCT00090857 ↗
registry MEDIAN Letrozole: -0.0065 (-0.097 to 0.068) g/cm^2 MEDIAN Placebo: -0.013 (-0.13 to 0.029) g/cm^2 analysis (superiority or other test); Letrozole vs Placebo; p = 0.70 NCT00090857 ↗
registry MEDIAN Letrozole: -0.017 (-0.059 to 0.023) g/cm^2 MEDIAN Placebo: -0.009 (-0.059 to 0.015) g/cm^2 analysis (superiority or other test); Letrozole vs Placebo; p = 0.03 NCT00090857 ↗
registry MEDIAN Letrozole: -0.0275 (-0.082 to 0.035) g/cm^2 MEDIAN Placebo: -0.001 (-0.075 to 0.025) g/cm^2 analysis (superiority or other test); Letrozole vs Placebo; p = 0.06 NCT00090857 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Letrozole | Other / unclassified | 2.5 mg | — |