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Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Metastatic Breast Cancer

Thank you

Trial Information

Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic


Inclusion Criteria:



- Has histologic or cytologic diagnosis of breast cancer; evidence of unresectable
locally recurrent or metastatic disease

- Has measurable or evaluable-only disease

- Is female, ≥18 yrs of age, post menopausal or surgically sterile

- HER2 negative, HR+, ER+ and/or PgR+ breast cancer

- 0-1 prior chemotherapy regimen for metastatic disease.

- Prior adjuvant or neoadjuvant chemotherapy completed at least 1 month prior

- Prior tamoxifen therapy is allowed

- No AI therapy for >1 year without recurrence

Exclusion Criteria:

- Pregnant or breast feeding

- Prior hormonal therapy for metastatic or locally recurrent disease

- >1 chemotherapy regimen for metastatic disease

- Pleural or pericardial effusion

- Serious cardiac condition

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the clinical benefit rate with letrozole or with letrozole plus dasatinib

Outcome Time Frame:

(CBR equal to CR+PR+SD ≥6 months)

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:

CA180-185

NCT ID:

NCT00696072

Start Date:

October 2008

Completion Date:

February 2015

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms

Name

Location
Virginia Oncology Associates Newport News, Virginia  23606
Rocky Mountain Cancer Centers Thornton, Colorado  80260
Tyler Cancer Center Tyler, Texas  75702
Cancer Care Northwest Spokane, Washington  99202
Willamette Valley Cancer Center Eugene, Oregon  97401-8122
Local Institution Chicago, Illinois  
Local Institution Bronx, New York  
Local Institution Cincinnati, Ohio  
Local Institution Vancouver, Washington  
Texas Oncology Dallas, Texas  
Local Institution Phoenix, Arizona  
Local Institution Fort Lauderdale, Florida  
Local Institution New Brunswick, New Jersey  
Local Institution Austin, Texas  
Medical Oncology Associates Kingston, Pennsylvania  18704
Central Indiana Cancer Centers Indianapolis, Indiana  46227
Texas Cancer Center at Medical City Dallas, Texas  75230
Dayton Oncology and Hematology Kettering, Ohio  
Local Institution Columbia, Missouri  
Northern Arizona Hematology & Oncology Associates Sedona, Arizona  86336
New York Oncology Hematology, PC Albany, New York  12208
Oncology & Hematology Associates of Southwest Virginia, Inc. Salem, Virginia  24153
Cancer Care Centers of South Texas San Antonio, Texas  78229
Yakima Valley Memorial Hospital/North Star Lodge Yakima, Washington  98902
Texas Oncology Cancer Care and Research Center Waco, Texas  76712
Florida Cancer Institute - New Hope New Port Richey, Florida  34655
Northwest Cancer Specialists, PC Portland, Oregon  97225
Arizona Oncology Associates D.B.A. Hematology Oncology Tucson, Arizona  85704
Texas Oncology-Central Austin Cancer Center Austin, Texas  78731
Texas Oncology Sammons Cancer Center Dallas, Texas  75246
Usor Dallas, Texas  75246
El Paso Cancer Treatment Ctr - East El Paso, Texas  79915
Texas Oncology-Plano East Plano, Texas  75075