Phase 3
N=298
Aromasin Vs Arimidex Study As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurrent Breast Cancer
Breast Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00143390 ↗Enrolled (actual)
298
Serious AEs
12.8%
Results posted
Jan 2012
Primary outcome: Primary: Time to Progression (TTP) - Expert Evaluation Committee Assessment — 13.8; 11.1 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- exemestane (Drug); anastrozole (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Pfizer
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression (TTP) - Expert Evaluation Committee Assessment |
13.8; 11.1 | — |
| SECONDARY Time to Progression (TTP) - Investigators Assessment |
13.8; 13.7 | — |
| SECONDARY Number of Participants With Objective Response - Investigators Assessment |
2; 3; 56; 47; 58; 50 | — |
| SECONDARY Number of Participants With Clinical Benefit - Investigator Assessment |
2; 3; 56; 47; 41; 49 | — |
| SECONDARY Overall Survival (OS) |
NA; 60.1 | — |
| SECONDARY Time to Treatment Failure (TTF) |
13.6; 11.1 | — |
Summary
To verify the non-inferiority of exemestane compared to anastrozole in time to tumor progression (TTP), the primary efficacy endpoint, in postmenopausal women with advanced/recurrent breast cancer.
Eligibility Criteria
Inclusion Criteria
- Have histologically or cytologically confirmed breast cancer at original diagnosis. At study entry, the patient must have metastatic progressive or locally recurrent inoperable breast cancer.
Exclusion Criteria
- Having received any hormonal therapy (e.g., Tamoxifen, LHRH-agonists) ovariectomy or any chemotherapy for advanced/recurrent breast cancer
Data sourced from ClinicalTrials.gov (NCT00143390). 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.