A Two-Arm Randomized Open Label Phase 2 Study Of CP-751,871 In Combination With Exemestane Versus Exemestane Alone As First Line Treatment For Postmenopausal Patients With Hormone Receptor Positive Advanced Breast Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms
Female
Breast Neoplasms
Trial Information
A Two-Arm Randomized Open Label Phase 2 Study Of CP-751,871 In Combination With Exemestane Versus Exemestane Alone As First Line Treatment For Postmenopausal Patients With Hormone Receptor Positive Advanced Breast Cancer
Inclusion Criteria:
- Postmenopausal women with a diagnosis of hormone receptor positive advanced breast
cancer
- HbA1c <5.7%
Exclusion Criteria:
- Previous treatment for advanced disease
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy of the exemestane plus CP-751,871 combination measured as Progression Free Survival
Outcome Time Frame:
60 months
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:
A4021004
NCT ID:
NCT00372996
Start Date:
February 2007
Completion Date:
March 2014
Related Keywords:
- Breast Neoplasms
- Breast Neoplasms
- Neoplasms
Name | Location |
|---|---|
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Crestview Hills, Kentucky 41017 |
| Pfizer Investigational Site | Rochester, Minnesota 55905 |
| Pfizer Investigational Site | Houston, Texas 77030 |
| Pfizer Investigational Site | Clearwater, Florida 33761 |
| Pfizer Investigational Site | North Adams, Massachusetts 01247 |
| Pfizer Investigational Site | Asheville, North Carolina 28801 |
| Pfizer Investigational Site | Washington, District of Columbia 20007-2197 |
| Pfizer Investigational Site | Burlington, Vermont 05401-3456 |
