drugset / Trial / NCT01237327
Multicenter Follow Up Study Of Subjects Who Participated In An Original Protocol Of Exemestane Vs. Megestrol Acetate In Postmenopausal Women With Metastatic Breast Cancer
Parallel-groupOpen-labelTreatment
Summary
Long term efficacy of exemestane as compared to megestrol acetate in the treatment of women with natural or induced postmenopausal status with advanced breast cancer whose disease has progressed following anti-estrogens or anti-estrogens plus chemotherapy and who had participated on an original study of exemestane vs megestrol : study 971-ONC-0028-080.
Timeline
- Start
- 2001-11
- Primary completion
- 2007-12
- Completion
- 2009-12
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Exemestane vs Megestrol Acetate; p = 0.3348; Hazard Ratio (HR) 0.7799 (95% CI 0.47 to 1.294); Log Rank NCT01237327 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Exemestane | Small molecule | 25 mg | Oral |
| Comparator | Megestrol Acetate | Other / unclassified | 160 mg | Oral |