Randomized Double-Blind Trial In Postmenopausal Women With Primary Breast Cancer Who Have Received Adjuvant Tamoxifen For 2-3 Years, Comparing Subsequent Adjuvant Exemestane Treatment With Further Tamoxifen
Phase 3
30 Years
N/A
30 Years
N/A
Not Enrolling
Female
Breast Neoplasms
Female
Breast Neoplasms
Trial Information
Randomized Double-Blind Trial In Postmenopausal Women With Primary Breast Cancer Who Have Received Adjuvant Tamoxifen For 2-3 Years, Comparing Subsequent Adjuvant Exemestane Treatment With Further Tamoxifen
Inclusion Criteria:
- postmenopausal women with histologically or cytologically confirmed primary breast
adenocarcinoma, receiving tamoxifen and have been treated with tamoxifen continuously
for between 2 and 3 years and one month, and still free of disease
Exclusion Criteria:
- unresectable breast cancer
- ER negative primary tumor
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Disease Free Survival (DFS)
Outcome Time Frame:
June 2003, February 2006, December 2009, February 2013
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
96-OEXE-031
NCT ID:
NCT00038467
Start Date:
February 1998
Completion Date:
March 2013
Related Keywords:
- Breast Neoplasms
- Breast Neoplasms
- Neoplasms
Name | Location |
|---|---|
| Pfizer Investigational Site | Birmingham, Alabama 35205 |
| Pfizer Investigational Site | Bronx, New York 10461 |
| Pfizer Investigational Site | Houston, Texas 77030 |
| Pfizer Investigational Site | Federal Way, Washington 98003 |
| Pfizer Investigational Site | Flagstaff, Arizona 86001 |
| Pfizer Investigational Site | Aurora, Colorado 80012 |
| Pfizer Investigational Site | Clearwater, Florida 33761 |
| Pfizer Investigational Site | Carmel, Indiana 46032 |
| Pfizer Investigational Site | Cedar Rapids, Iowa 52403 |
| Pfizer Investigational Site | North Adams, Massachusetts 01247 |
| Pfizer Investigational Site | Eugene, Oregon 97401 |
