Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen For 2.5- 3 Years Followed By Exemestane (Aromasin) For A Total Of 5 Years As Adjuvant Therapy For Postmenopausal, Receptor Positive, Node Negative or Node Positive Breast Cancer Patients
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years
Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 2.75 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.
Baseline (Month 0) up to 2.75 years
No
Pfizer CT.gov Call Center
Study Director
Pfizer
United States: Food and Drug Administration
971-ONC-0028-081
NCT00036270
August 2001
February 2011
Name | Location |
---|---|
Pfizer Investigational Site | Birmingham, Alabama 35205 |
Pfizer Investigational Site | Rochester, Minnesota 55905 |
Pfizer Investigational Site | Cincinnait, Ohio 45236 |
Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
Pfizer Investigational Site | Bronx, New York 10461 |
Pfizer Investigational Site | Houston, Texas 77030 |
Pfizer Investigational Site | Richmond, Virginia 23249 |
Pfizer Investigational Site | Federal Way, Washington 98003 |
Pfizer Investigational Site | Flagstaff, Arizona 86001 |
Pfizer Investigational Site | North Little Rock, Arkansas 72117 |
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 | Kansas City, Kansas 66112 |
Pfizer Investigational Site | Westminster, Maryland 21157 |
Pfizer Investigational Site | North Adams, Massachusetts 01247 |
Pfizer Investigational Site | Columbia, Missouri 65201 |
Pfizer Investigational Site | Las Vegas, Nevada 89128 |
Pfizer Investigational Site | Santa Fe, New Mexico 87505 |
Pfizer Investigational Site | Asheville, North Carolina 28801 |
Pfizer Investigational Site | Bartlesville, Oklahoma 74006 |
Pfizer Investigational Site | Eugene, Oregon 97401 |
Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
Pfizer Investigational Site | Easley,, South Carolina 29640 |