Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor
NCT ID: NCT00754325
Last Updated: 2016-05-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2008-09-30
2014-01-31
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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Arm 1 (Dasatinib +Fulvestrant)
Dasatinib
Tablets, Oral, 100 mg, once daily (QD), upto 2 years
Fulvestrant
Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1. In subsequent cycles, 500 mg IM administered on Day 1. IM day 1 and 15 first cycle then IM Day 1 for all other cycles for 2 years
Arm 2 (Fulvestrant)
Fulvestrant
Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1. In subsequent cycles, 500 mg IM administered on Day 1. IM day 1 and 15 first cycle then IM Day 1 for all other cycles for 2 years
Interventions
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Dasatinib
Tablets, Oral, 100 mg, once daily (QD), upto 2 years
Fulvestrant
Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1. In subsequent cycles, 500 mg IM administered on Day 1. IM day 1 and 15 first cycle then IM Day 1 for all other cycles for 2 years
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measureable or evaluable-only disease
* human epidermal growth factor receptor 2+ (HER2+) or HER2- breast cancer
* Males and females ≥18 years of age
* Females are post menopausal or surgically sterile
* Recurrent or progressive advanced breast cancer (locally-advanced or metastatic), that has progressed: (a) during or within 12 months after completion of adjuvant Aromatase Inhibitor (AI) treatment OR (b) during AI treatment in advanced setting (metastatic therapy)
Exclusion Criteria
* \>1 chemotherapy regimen for advanced disease
* Pleural or pericardial effusion
* Serious cardiac condition
18 Years
ALL
No
Sponsors
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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 Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope
Tucson, Arizona, United States
Florida Cancer Institute - New Hope
Hudson, Florida, United States
Cancer Centers Of Florida, P.A
Ocoee, Florida, United States
Central Indiana Cancer Centers
Carmel, Indiana, United States
Kansas City Cancer Center, Llc.
Overland Park, Kansas, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States
Missouri Cancer Associates
Columbia, Missouri, United States
New York Oncology Hematology, Pc
Troy, New York, United States
Raleigh Hematology Oncology Associates
Raleigh, North Carolina, United States
Willamette Valley Cancer Center
Eugene, Oregon, United States
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States
Texas Oncology-Central Austin Cancer Center
Austin, Texas, United States
Texas Oncology, P.A.
Bedford, Texas, United States
Texas Oncology, P.A.
Dallas, Texas, United States
Texas Oncology
Dallas, Texas, United States
Texas Oncology Sammons Cancer Center
Dallas, Texas, United States
Texas Cancer Center
Denton, Texas, United States
El Paso Cancer Treatment Ctr - West
El Paso, Texas, United States
Us Oncology Research, Inc.
Houston, Texas, United States
Quest Diagnostic Clinical Laboratories Inc
Houston, Texas, United States
Cancer Care Centers Of South Texas
San Antonio, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Texas Oncology Cancer Care And Research Center
Waco, Texas, United States
Texas Oncology, P.A.
Webster, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Oncology & Hematology Associates Of Southwest Virginia, Inc.
Salem, Virginia, United States
Virginia Center Specialists, Pc
Woodbridge, Virginia, 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 06-030
Identifier Type: -
Identifier Source: secondary_id
CA180-158
Identifier Type: -
Identifier Source: org_study_id
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