A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) Administered Intravenously to Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
- Conditions
- Metastatic Breast Cancer
- Interventions
- Registration Number
- NCT00509769
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
This was a multi-institutional, open-label, single-arm, Phase II study of trastuzumab emtansine (T-DM1) administered by intravenous (IV) infusion to patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- Signed informed consent form.
- 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.
- Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biological therapy for the treatment of breast cancer within 2 weeks of the first study treatment.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Trastuzumab emtansine 3.6 mg/kg Trastuzumab emtansine [Kadcyla] 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.
- Primary Outcome Measures
Name Time Method Objective Response Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST) Randomization until the analysis data cutoff-dates of 31 Jan 2009 (6 months after the last patient was enrolled in the study) and 25 Jun 2009 (approximately 12 months after the last patient was enrolled in the study, up to 23 months) Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions ≥ 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.
- Secondary Outcome Measures
Name Time Method Progression-free Survival Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months) Progression-free survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.
Duration of Objective Response (OR) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST) Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months) For patients who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a patient's objective response to the time of disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response.
Progression-free Survival (PFS) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST) Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months) Progression-free survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.
Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months) For patients who achieved an objective response, duration of objective response was defined as the time from the first tumor assessment that supported a patient's objective response to the time of disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate the duration of objective response.
Objective Response Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Randomization until the final analysis cut-off date of 25 Jun 2009 (end of the study, approximately 12 months after the last patient was enrolled, up to 23 months) Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions ≥ 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.
Trial Locations
- Locations (38)
USO
🇺🇸Dallas, Texas, United States
Lynn Cancer Institute - West
🇺🇸Boca Raton, Florida, United States
Florida Cancer Care
🇺🇸Davie, Florida, United States
Northern Utah Associates
🇺🇸Ogden, Utah, United States
USO - Tyler Cancer Ctr
🇺🇸Tyler, Texas, United States
Waco Cancer Care & Research Ce
🇺🇸Waco, Texas, United States
Texas Oncology Cancer Center
🇺🇸Austin, Texas, United States
Washington Cancer Institute
🇺🇸Washington, District of Columbia, United States
Little Rock Hem Onc Assoc
🇺🇸Little Rock, Arkansas, United States
Rocky Mountain Cancer Center
🇺🇸Denver, Colorado, United States
Gulfcoast Oncology Associates
🇺🇸Saint Petersburg, Florida, United States
Hem/Onc Assoc - Treasure Coast
🇺🇸Port St Lucie, Florida, United States
Northwest Georgia Onc Ctrs PC
🇺🇸Marietta, Georgia, United States
John McClean, M.D. - Private P
🇺🇸Galesburg, Illinois, United States
Kansas City Cancer Center, LLC
🇺🇸Lee's Summit, Missouri, United States
St. Barnabas Health Care Sys
🇺🇸Livingston, New Jersey, United States
Texas Oncology, P.A.
🇺🇸Houston, Texas, United States
Carolinas Hem-Oncology Assoc
🇺🇸Charlotte, North Carolina, United States
Cancer Specialists of South Te
🇺🇸Corpus Christi, Texas, United States
Eastchester Center/Cancer Care
🇺🇸Bronx, New York, United States
Midwestern Regional Med Center
🇺🇸Eugene, Oregon, United States
US Oncology Research, Inc.
🇺🇸Dallas, Texas, United States
El Paso Cancer Treatment Ctr
🇺🇸El Paso, Texas, United States
Texas Oncology PA
🇺🇸Fort Worth, Texas, United States
US Oncology
🇺🇸Midland, Texas, 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
New York Oncology Hematology
🇺🇸Albany, New York, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Missouri Cancer Associates
🇺🇸Columbia, Missouri, United States
Cedar Valley Med Specialists
🇺🇸Waterloo, Iowa, United States
Raleigh Hemotology & Oncology
🇺🇸Raleigh, North Carolina, United States
St. Louis Cancer & Breast Inst
🇺🇸Saint Louis, Missouri, United States
Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Bay Area Oncology
🇺🇸Tampa, Florida, United States
Kentuckiana Cancer Institute
🇺🇸Louisville, Kentucky, United States
Minnesota Oncology Hematology,
🇺🇸Minneapolis, Minnesota, United States
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