Status:
COMPLETED
A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Previously Received a Trastuzumab-Containing Regimen
Lead Sponsor:
Genentech, Inc.
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
This is a phase I, multicenter, open-label, dose-escalation study of single-agent trastuzumab-MCC-DM1 administered by intravenous (IV) infusion in patients with HER2-positive metastatic breast cancer ...
Eligibility Criteria
Inclusion
- Histologically documented, incurable, locally advanced or metastatic breast cancer
- Evaluable or measurable HER2-positive disease
- History of progression during or within 60 days after treatment with any prior trastuzumab-containing chemotherapy regimen for HER2-positive breast cancer
- Previous treatment with chemotherapy for MBC
- Granulocyte count ≥ 1,500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 9 g/dL
- Serum bilirubin ≤ 1.5 mg/dL; AST, ALT, and alkaline phosphatase ≤ 2.5 × upper limit of normal (ULN) except for: Patients with hepatic metastases: ALT and AST ≤ 5 × ULN Patients with hepatic and/or bone metastases: alkaline phosphatase ≤ 5 × ULN
- Serum creatinine ≤ 1.5 mg/dL or creatinine clearance of ≥ 60 mL/min based on a 24-hour urine collection
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Women of childbearing potential and men must agree to use an effective method of birth control (e.g., hormonal, barrier) while receiving study treatment
Exclusion
- History of significant cardiac disease, unstable angina, CHF, myocardial infarction, or ventricular arrhythmia requiring medication
- History of Grade ≥ 3 hypersensitivity reaction to trastuzumab
- History of any toxicity to trastuzumab that resulted in trastuzumab being permanently discontinued
- Symptomatic brain metastases or any radiation or surgery for brain metastases within 3 months of first study treatment
- Require supplemental oxygen for daily activities
- Grade ≥ 2 peripheral neuropathy
- Bisphosphonate therapy for symptomatic hypercalcemia
- Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic therapy for the treatment of breast cancer within 4 weeks of first study treatment
- Any experimental therapy within 4 weeks of first study treatment
- Any major surgical procedure within 4 weeks of first study treatment
- History of clinically symptomatic liver disease, including viral or other hepatitis, current or history of alcoholism, or cirrhosis
- Pregnancy or lactation
- Cardiac troponin I ≥ 0.2 ng/mL
- Ejection fraction \< 50% or below the lower limit of normal determined by echocardiogram or MUGA scan
- Prior cumulative doxorubicin dose of \> 360 mg/m2 or equivalent
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00932373
Start Date
April 1 2006
End Date
June 1 2009
Last Update
August 26 2015
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