drugset / Trial / NCT00066573

Exemestane or Anastrozole in Treating Postmenopausal Women Who Have Undergone Surgery for Primary Breast Cancer

NCT00066573 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy, using exemestane or anastrozole, may fight breast cancer by reducing the production of estrogen. It is not yet known whether exemestane is more effective than anastrozole in preventing the recurrence of breast cancer. PURPOSE: This randomized phase III trial is studying exemestane to see how well it works compared to anastrozole in preventing cancer recurrence in postmenopausal women who have undergone surgery for primary breast cancer.

Timeline

Start
2003-06-06
Primary completion
2010-11-07
Completion
2012-01-06

Outcome

Missed primary endpoint

registry analysis (superiority test); Exemestane vs Anastrozole; p = 0.85; Hazard Ratio (HR) 1.02 (95% CI 0.87 to 1.18); Log Rank NCT00066573 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Anastrozole Other / unclassified 1 mg Oral
Subject Exemestane Small molecule 25 mg Oral

Indications