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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
Open (Enrolling)
Female
Breast Cancer

Thank you

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 ClinicRochester, Minnesota  55905
Sharp Clinical Oncology ResearchSan Diego, California  92123
Mayo Clinic ArizonaScottsdale, Arizona  85259
The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009
Presbyterian Hospital Cancer ResearchCharlotte, North Carolina  28204
Northwest Hospital CenterRandallstown, Maryland  21133
Duke University Medical Center-Dept Of MedicineDurham, North Carolina  27710
Pharma ResourceEast Providence, Rhode Island  02915
Georgia Cancer Specialists I, PCAtlanta, Georgia  30341
Donald W. Hill M.D., P.C.Casa Grande, Arizona  85122
Univ Of Al At BirminghamBirmingham, Alabama  35294
Illinois Cancercare, PcPeoria, Illinois  61615
Masonic Cancer Ctr, University Of MinnesotaMinneapolis, Minnesota  55455
The Sidney Kimmel Comprehensive Cancer Ctr At Johns HopkinsBaltimore, Maryland  21231
Unv. Of Nc At Chapel HillChapel Hill, North Carolina  27599