A Randomized Phase 2 Study Of SU011248 Versus Standard-Of-Care For Patients With Previously Treated, Advanced, Triple Receptor Negative (ER, PR, HER2) Breast Cancer
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-Free Survival (PFS)
Time in months from start of study treatment to first documentation of objective tumor progression (per RECIST) or death due to any cause. PFS was calculated as (first event date minus first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Baseline, every 6 weeks until disease progression or death (up to 3 years from first dose)
No
Pfizer CT.gov Call Center
Study Director
Pfizer
United States: Food and Drug Administration
A6181077
NCT00246571
January 2006
June 2011
Name | Location |
---|---|
Pfizer Investigational Site | Blendora, California 91740 |
Pfizer Investigational Site | Atlanta, Georgia 30342 |
Pfizer Investigational Site | Detroit, Michigan 48201 |
Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
Pfizer Investigational Site | Bronx, New York 10461 |
Pfizer Investigational Site | Houston, Texas 77030 |
Pfizer Investigational Site | Federal Way, Washington 98003 |
Pfizer Investigational Site | Aurora, Colorado 80012 |
Pfizer Investigational Site | Clearwater, Florida 33761 |
Pfizer Investigational Site | Carmel, Indiana 46032 |
Pfizer Investigational Site | Columbia, Missouri 65201 |
Pfizer Investigational Site | Asheville, North Carolina 28801 |
Pfizer Investigational Site | Bartlesville, Oklahoma 74006 |
Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
Pfizer Investigational Site | Bristol, Tennessee 37620 |
Pfizer Investigational Site | Olive Branch, Mississippi 38654 |
Pfizer Investigational Site | Livingston, New Jersey 07039 |
Pfizer Investigational Site | Washington, District of Columbia 20007-2197 |