A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) Administered Intravenously to Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
A Phase II, Single-arm, Open-label Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed While Receiving HER2-Directed Therapy
1 other identifier
interventional
112
1 country
40
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2007
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 27, 2007
CompletedFirst Posted
Study publicly available on registry
July 31, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
April 2, 2013
CompletedApril 2, 2013
February 1, 2013
1.5 years
July 27, 2007
February 22, 2013
February 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)
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.
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)
Secondary Outcomes (5)
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)
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)
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)
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)
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)
Study Arms (1)
Trastuzumab emtansine 3.6 mg/kg
EXPERIMENTALPatients 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.
Interventions
Trastuzumab emtansine was provided in either a liquid or a lyophilized formulation.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (40)
Little Rock Hem Onc Assoc
Little Rock, Arkansas, 72205, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80220, United States
Washington Cancer Institute
Washington D.C., District of Columbia, 20010, United States
Lynn Cancer Institute - West
Boca Raton, Florida, 33428, United States
Florida Cancer Care
Davie, Florida, 33328, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Hem/Onc Assoc - Treasure Coast
Port Saint Lucie, Florida, 34952, United States
Gulfcoast Oncology Associates
St. Petersburg, Florida, 33705, United States
Bay Area Oncology
Tampa, Florida, 33607, United States
Northwest Georgia Onc Ctrs PC
Marietta, Georgia, 30060, United States
John McClean, M.D. - Private P
Galesburg, Illinois, 61401, United States
Cedar Valley Med Specialists
Waterloo, Iowa, 50702, United States
Kentuckiana Cancer Institute
Louisville, Kentucky, 40202, United States
Minnesota Oncology Hematology,
Minneapolis, Minnesota, 55404, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
Kansas City Cancer Center, LLC
Lee's Summit, Missouri, 64064, United States
St. Louis Cancer & Breast Inst
St Louis, Missouri, 63141, United States
St. Barnabas Health Care Sys
Livingston, New Jersey, 07039, United States
New York Oncology Hematology
Albany, New York, 12206, United States
Eastchester Center/Cancer Care
The Bronx, New York, 10469, United States
Carolinas Hem-Oncology Assoc
Charlotte, North Carolina, 28203, United States
Raleigh Hemotology & Oncology
Raleigh, North Carolina, 27607, United States
Midwestern Regional Med Center
Eugene, Oregon, 97401-8122, United States
Texas Oncology Cancer Center
Austin, Texas, 78731, United States
Texas Oncology, P.A.
Bedford, Texas, 76022, United States
Cancer Specialists of South Te
Corpus Christi, Texas, 78412, United States
US Oncology Research, Inc.
Dallas, Texas, 75204, United States
USO
Dallas, Texas, 75230-2510, United States
Texas Oncology, P.A.
Dallas, Texas, 75231-4400, United States
Sammons Cancer Center
Dallas, Texas, 75246, United States
El Paso Cancer Treatment Ctr
El Paso, Texas, 79915, United States
Texas Oncology PA
Fort Worth, Texas, 76104, United States
Texas Oncology, P.A.
Houston, Texas, 77024-2305, United States
US Oncology
Midland, Texas, 79701, United States
USO - Tyler Cancer Ctr
Tyler, Texas, 75702, United States
Waco Cancer Care & Research Ce
Waco, Texas, 76712, United States
Northern Utah Associates
Ogden, Utah, 84403, United States
Fairfax N Virginia Hem/Onc PC
Fairfax, Virginia, 22031, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
Northwest Cancer Specialists
Vancouver, Washington, 98684, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Genentech, Inc.
Study Officials
- STUDY DIRECTOR
Scott Holden, M.D.
Genentech, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2007
First Posted
July 31, 2007
Study Start
July 1, 2007
Primary Completion
January 1, 2009
Study Completion
June 1, 2009
Last Updated
April 2, 2013
Results First Posted
April 2, 2013
Record last verified: 2013-02