A Study of Trastuzumab-MCC-DM1 in Patients With HER2- Positive Locally Advanced or Metastatic Breast Cancer

Exclusion Criteria

• •Less than 14 days from the first study treatment since the last anti-cancer therapy, including chemotherapy, biologic, experimental, immune, hormonal or endocrine therapy
• •Prior T-DM1 therapy
• •History of exposure to cumulative doses of select anthracyclines
• •History of intolerance or hypersensitivity to trastuzumab, murine proteins, or any of the excipients, that resulted in trastuzumab being permanently discontinued
• •Brain metastases that are untreated or progressive or currently require any type of therapy, including radiation, surgery, and/or steroids to control symptoms from brain metastases within 30 days before the first study treatment
• •Peripheral neuropathy of Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0, at the time of the first study treatment
• •History of clinically significant cardiac dysfunction
• •Current known active infection with HIV, hepatitis B virus, or hepatitis C virus
• •Current severe, uncontrolled systemic disease
• •Major surgical procedure or significant traumatic injury within 28 days prior to first study treatment
• •Pregnancy or lactation
• •NOTE: The site selection process has been completed. Patients can enroll at participating sites.