A Study of Trastuzumab Emtansine (T-DM1) Sequentially With Anthracycline-based Chemotherapy, as Adjuvant or Neoadjuvant Therapy for Patients With Early Stage Herceptin (HER)2-positive Breast Cancer

Exclusion Criteria

• •Stage IV breast cancer or bilateral breast cancer.
• •Pregnant or breastfeeding women.
• •History of other malignancy within the previous 5 years, except contralateral breast cancer and ductal carcinoma in situ (DCIS)/lobular carcinoma in situ (LCIS), appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with outcome similar to those mentioned above.
• •Radiation therapy, immunotherapy, or biotherapy within 5 years before study enrollment; non-cardiotoxic chemotherapy for malignancy treated \> 5 years before study enrollment is allowed. Patients receiving AC/FEC in a similar fashion to the study treatment prescribed for adjuvant or neoadjuvant treatment of breast cancer will be allowed to enroll in the study after the completion of their AC/FEC. No other prior history of cardiotoxic chemotherapy is allowed.
• •Active cardiac history.
• •Current chronic daily treatment with oral corticosteroids or equivalent.
• •Patients with severe dyspnea at rest or requiring supplementary oxygen therapy.
• •Active, unresolved infections at screening.
• •Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
• •Major surgery within 4 weeks before enrollment that is unrelated to the breast cancer.
• •Patients for whom concomitant radiotherapy + T-DM1 may be contraindicated yet radiation therapy is planned.
• •Known hypersensitivity to any of the study drugs or derivatives, including murine proteins.
• •Grade ≥ 2 peripheral neuropathy at Baseline.