A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) Administered Intravenously to Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
NCT ID: NCT00509769
Last Updated: 2013-04-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
112 participants
INTERVENTIONAL
2007-07-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Trastuzumab emtansine 3.6 mg/kg
Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
Trastuzumab emtansine [Kadcyla]
Trastuzumab emtansine was provided in either a liquid or a lyophilized formulation.
Interventions
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Trastuzumab emtansine [Kadcyla]
Trastuzumab emtansine was provided in either a liquid or a lyophilized formulation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC); tissue (slides or blocks) available for HER2 confirmation.
* History of progression on HER2-directed therapy for the treatment of HER2-positive breast cancer.
* At least 1, and no more than 3, chemotherapy regimens for MBC.
* Granulocyte count ≥ 1500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 9 g/dL.
* Serum bilirubin ≤ 1.5 mg/dL, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 2.5x the upper limit of normal (ULN).
* Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Exclusion Criteria
* Prior cumulative doxorubicin dose \> 360 mg/m\^2 or the equivalent.
* History of significant cardiac disease, unstable angina, congestive heart failure (CHF), myocardial infarction, or ventricular arrythmia requiring medication.
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Scott Holden, M.D.
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Little Rock Hem Onc Assoc
Little Rock, Arkansas, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
Washington Cancer Institute
Washington D.C., District of Columbia, United States
Lynn Cancer Institute - West
Boca Raton, Florida, United States
Florida Cancer Care
Davie, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Hem/Onc Assoc - Treasure Coast
Port Saint Lucie, Florida, United States
Gulfcoast Oncology Associates
St. Petersburg, Florida, United States
Bay Area Oncology
Tampa, Florida, United States
Northwest Georgia Onc Ctrs PC
Marietta, Georgia, United States
John McClean, M.D. - Private P
Galesburg, Illinois, United States
Cedar Valley Med Specialists
Waterloo, Iowa, United States
Kentuckiana Cancer Institute
Louisville, Kentucky, United States
Minnesota Oncology Hematology,
Minneapolis, Minnesota, United States
Missouri Cancer Associates
Columbia, Missouri, United States
Kansas City Cancer Center, LLC
Lee's Summit, Missouri, United States
St. Louis Cancer & Breast Inst
St Louis, Missouri, United States
St. Barnabas Health Care Sys
Livingston, New Jersey, United States
New York Oncology Hematology
Albany, New York, United States
Eastchester Center/Cancer Care
The Bronx, New York, United States
Carolinas Hem-Oncology Assoc
Charlotte, North Carolina, United States
Raleigh Hemotology & Oncology
Raleigh, North Carolina, United States
Midwestern Regional Med Center
Eugene, Oregon, United States
Texas Oncology Cancer Center
Austin, Texas, United States
Texas Oncology, P.A.
Bedford, Texas, United States
Cancer Specialists of South Te
Corpus Christi, Texas, United States
US Oncology Research, Inc.
Dallas, Texas, United States
USO
Dallas, Texas, United States
Texas Oncology, P.A.
Dallas, Texas, United States
Sammons Cancer Center
Dallas, Texas, United States
El Paso Cancer Treatment Ctr
El Paso, Texas, United States
Texas Oncology PA
Fort Worth, Texas, United States
Texas Oncology, P.A.
Houston, Texas, United States
US Oncology
Midland, Texas, United States
USO - Tyler Cancer Ctr
Tyler, Texas, United States
Waco Cancer Care & Research Ce
Waco, Texas, United States
Northern Utah Associates
Ogden, Utah, United States
Fairfax N Virginia Hem/Onc PC
Fairfax, Virginia, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Northwest Cancer Specialists
Vancouver, Washington, United States
Countries
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Other Identifiers
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TDM4258g
Identifier Type: -
Identifier Source: org_study_id
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