Phase 3
Completed N=84
Multicenter Follow Up Study Of Subjects Who Participated In An Original Protocol Of Exemestane Vs. Megestrol Acetate In Postmenopausal Women With Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT01237327 ↗Enrolled (actual)
84
Serious AEs
3.7%
Results posted
Mar 2011
Primary outcomePrimary: Overall Survival — 29.2; 16.3 months — p=0.3348
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
29.2; 16.3 | 0.3348 |
| SECONDARY Objective Response Rate (ORR) |
23.3; 12.2 | — |
| SECONDARY Duration of Response (DR) |
12.9; 35.4 | — |
| SECONDARY Time to Tumor Progression (TTP) |
6.0; 3.7 | — |
| SECONDARY Time to Treatment Failure (TTF) |
6.0; 3.7 | — |
Eligibility Criteria
Inclusion Criteria
- Previous participation in study 971-ONC-0028-080.
Exclusion Criteria
- Subjects who had not previously participated in study 971-ONC-0028-080.
Data sourced from ClinicalTrials.gov (NCT01237327). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.