A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Previously Received a Trastuzumab-Containing Regimen

Exclusion Criteria

• •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