Phase 2
Completed N=205
A Clinical Trial to Compare Efficacy and Tolerability of Faslodex With Arimidex in Patients With Advanced Breast Cancer
Source: ClinicalTrials.gov NCT00274469 ↗Enrolled (actual)
205
Serious AEs
22.6%
Results posted
Aug 2009
Primary outcomePrimary: Clinical Benefit Rate — 72.5; 67.0 Percentage of Participants — p=0.386
Summary
The purpose of this study is to compare the efficacy and tolerability of Faslodex (fulvestrant) with Arimidex (anastrozole) in postmenopausal women with hormone receptor positive advanced breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Benefit Rate |
72.5; 67.0 | 0.386 |
| SECONDARY Objective Response Rate |
36.0; 35.5 | 0.947 |
| SECONDARY Time to Progression |
NA; 381 | 0.0496 sig |
| SECONDARY Time to Treatment Failure |
536; 387 | 0.05 |
| SECONDARY Time to Progression (Investigator Assessed) |
712; 400 | 0.01 sig |
Eligibility Criteria
Inclusion Criteria
- Confirmed hormone receptor positive advanced breast cancer, postmenopausal women
Exclusion Criteria
- Previous treatment for advanced breast cancer (previous treatment for early breast cancer is allowed).
Data sourced from ClinicalTrials.gov (NCT00274469). 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.