A Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function

Exclusion Criteria

• •History of Grade \>/=3 infusion reaction, hypersensitivity reaction, or pneumonitis in response to trastuzumab
• •Investigational therapy or any other anticancer therapy \</=28 days before first study treatment
• •Previous treatment with trastuzumab emtansine
• •Brain metastases that are untreated or symptomatic or require therapy to control symptoms or any radiation, surgery or other therapy to control symptoms from brain metastases within 1 month of the first study treatment
• •History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those mentioned above
• •Current peripheral neuropathy of Grade \>/=2
• •Child-Pugh Class C hepatic impairment
• •Encephalopathy \>/= Grade 2
• •For patients with normal hepatic function: history of drug or alcohol addiction or history of hepatitis B and/or hepatitis C
• •Active hepatitis A, B and/or C
• •Current unstable ventricular arrhythmia requiring treatment
• •History of symptomatic CHF (NYHA Classes II-IV)
• •History of myocardial infarction or unstable angina within 6 months of enrollment
• •History of a decrease in LVEF to\<40% or symptomatic CHF with previous trastuzumab treatment
• •Pregnant or lactating women
• •Known HIV infection