A Phase 2 Study of BMS-754807 Combined With Letrozole or BMS-754807 Alone in Hormone Receptor-Positive Breast Cancer Subjects With Acquired Resistance to Non-Steroidal Aromatase Inhibitors
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer
Female
Breast Cancer
Trial Information
A Phase 2 Study of BMS-754807 Combined With Letrozole or BMS-754807 Alone in Hormone Receptor-Positive Breast Cancer Subjects With Acquired Resistance to Non-Steroidal Aromatase Inhibitors
Inclusion Criteria:
- Postmenopausal women with hormone receptor-positive and HER-2 negative breast cancer
- Disease progression following non-steroidal aromatase inhibitor treatment
Exclusion Criteria:
- Known symptomatic brain metastasis
- Medical condition requiring chronic steroids
- History of Type 1 or 2 Diabetes
- Uncontrolled or significant cardiovascular (CV) disease
- Concomitant second malignancies
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression free survival rate at 24 weeks
Outcome Time Frame:
24 weeks after initiating study treatment
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA191-011
NCT ID:
NCT01225172
Start Date:
June 2011
Completion Date:
June 2013
Related Keywords:
- Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
| Sharp Clinical Oncology Research | San Diego, California 92123 |
| Mayo Clinic Arizona | Scottsdale, Arizona 85259 |
| The University of Texas MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| Presbyterian Hospital Cancer Research | Charlotte, North Carolina 28204 |
| Northwest Hospital Center | Randallstown, Maryland 21133 |
| Duke University Medical Center-Dept Of Medicine | Durham, North Carolina 27710 |
| Pharma Resource | East Providence, Rhode Island 02915 |
| Georgia Cancer Specialists I, PC | Atlanta, Georgia 30341 |
| Donald W. Hill M.D., P.C. | Casa Grande, Arizona 85122 |
| Univ Of Al At Birmingham | Birmingham, Alabama 35294 |
| Illinois Cancercare, Pc | Peoria, Illinois 61615 |
| Masonic Cancer Ctr, University Of Minnesota | Minneapolis, Minnesota 55455 |
| The Sidney Kimmel Comprehensive Cancer Ctr At Johns Hopkins | Baltimore, Maryland 21231 |
| Unv. Of Nc At Chapel Hill | Chapel Hill, North Carolina 27599 |
