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
NCT ID: NCT00696072
Last Updated: 2016-06-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2008-08-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A1
Dasatinib
Tablets, Oral, 100 mg once daily, up to 2 years
Letrozole
Tablets, Oral, 2.5 mg, once daily, up to 2 years
A2
Letrozole
Tablets, Oral, 2.5 mg, once daily, up to 2 years
Interventions
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Dasatinib
Tablets, Oral, 100 mg once daily, up to 2 years
Letrozole
Tablets, Oral, 2.5 mg, once daily, up to 2 years
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Prior hormonal therapy for metastatic or locally recurrent disease
* \>1 chemotherapy regimen for metastatic disease
* Pleural or pericardial effusion
* Serious cardiac condition
18 Years
FEMALE
No
Sponsors
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US Oncology Research
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, United States
Arizona Oncology Associates D.B.A. Hematology Oncology
Tucson, Arizona, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Florida Cancer Institute - New Hope
Hudson, Florida, United States
Central Indiana Cancer Centers
Carmel, Indiana, United States
New York Oncology Hematology, Pc
Troy, New York, United States
Dayton Oncology And Hematology
Kettering, Ohio, United States
Willamette Valley Cancer Center
Eugene, Oregon, United States
Northwest Cancer Specialists, Pc
Portland, Oregon, United States
Medical Oncology Associates
Kingston, Pennsylvania, United States
Texas Oncology-Central Austin Cancer Center
Austin, Texas, United States
Texas Oncology
Bedord, Texas, United States
Texas Cancer Center At Medical City
Dallas, Texas, United States
Texas Oncology
Dallas, Texas, United States
Texas Oncology Sammons Cancer Center
Dallas, Texas, United States
El Paso Cancer Treatment Ctr - East
El Paso, Texas, United States
Texas Oncology
Fort Worth, Texas, United States
Texas Oncology
Garland, Texas, United States
Texas Oncology
Houston, Texas, United States
Texas Oncology-Plano East
Plano, Texas, United States
Cancer Care Centers Of South Texas
San Antonio, Texas, United States
Texas Oncology Cancer Center - Sugar Land
Sugar Land, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Texas Oncology Cancer Care And Research Center
Waco, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Oncology & Hematology Associates Of Southwest Virginia, Inc.
Salem, Virginia, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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USOR 06-185
Identifier Type: -
Identifier Source: secondary_id
CA180-185
Identifier Type: -
Identifier Source: org_study_id
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