Clinical trial NCT00509769: A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) Administered Intravenously to Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Keywords: Trastuzumab emtansine
MBC
Breast cancer
HER2-positive breast cancer
HER2
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2007-07-31
Enrollment: 112
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Objective Response Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 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:
measure: Duration of Objective Response (OR) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 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)
measure: Progression-free Survival (PFS) Assessed by the Independent Review Facility Using Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 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)
measure: Objective Response Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 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)
measure: Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 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)
measure: Progression-free Survival Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 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)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Little Rock Hem Onc Assoc
state: Arkansas
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Washington
country: United States
facility: Washington Cancer Institute
state: District of Columbia
city: Boca Raton
country: United States
facility: Lynn Cancer Institute - West
state: Florida
city: Davie
country: United States
facility: Florida Cancer Care
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Port St Lucie
country: United States
facility: Hem/Onc Assoc - Treasure Coast
state: Florida
city: Saint Petersburg
country: United States
facility: Gulfcoast Oncology Associates
state: Florida
city: Tampa
country: United States
facility: Bay Area Oncology
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Onc Ctrs PC
state: Georgia
city: Galesburg
country: United States
facility: John McClean, M.D. - Private P
state: Illinois
city: Waterloo
country: United States
facility: Cedar Valley Med Specialists
state: Iowa
city: Louisville
country: United States
facility: Kentuckiana Cancer Institute
state: Kentucky
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology,
state: Minnesota
city: Columbia
country: United States
facility: Missouri Cancer Associates
state: Missouri
city: Lee's Summit
country: United States
facility: Kansas City Cancer Center, LLC
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Cancer & Breast Inst
state: Missouri
city: Livingston
country: United States
facility: St. Barnabas Health Care Sys
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology
state: New York
city: Bronx
country: United States
facility: Eastchester Center/Cancer Care
state: New York
city: Charlotte
country: United States
facility: Carolinas Hem-Oncology Assoc
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Hemotology & Oncology
state: North Carolina
city: Eugene
country: United States
facility: Midwestern Regional Med Center
state: Oregon
city: Austin
country: United States
facility: Texas Oncology Cancer Center
state: Texas
city: Bedford
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Corpus Christi
country: United States
facility: Cancer Specialists of South Te
state: Texas
city: Dallas
country: United States
facility: US Oncology Research, Inc.
state: Texas
city: Dallas
country: United States
facility: USO
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Dallas
country: United States
facility: Sammons Cancer Center
state: Texas
city: El Paso
country: United States
facility: El Paso Cancer Treatment Ctr
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology PA
state: Texas
city: Houston
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Midland
country: United States
facility: US Oncology
state: Texas
city: Tyler
country: United States
facility: USO - Tyler Cancer Ctr
state: Texas
city: Waco
country: United States
facility: Waco Cancer Care & Research Ce
state: Texas
city: Ogden
country: United States
facility: Northern Utah Associates
state: Utah
city: Fairfax
country: United States
facility: Fairfax N Virginia Hem/Onc PC
state: Virginia
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists
state: Washington
Study officials:
affiliation: Genentech, Inc.
name: Scott Holden, M.D.
role: STUDY_DIRECTOR
References: