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

Inclusion Criteria: * Adult patients ≥ 18 years of age. * Locally advanced, inflammatory, or early stage, unilateral, and histologically confirmed invasive breast cancer documented at a local laboratory (patients with inflammatory breast cancer must be able to have a core needle biopsy). * Herceptin (HER)2-positive tumor, confirmed by central testing using immunohistochemistry (IHC) and in situ hybridization (ISH) methods. * Willingness to receive anthracycline-based chemotherapy or have received doxorubicin/cyclophosphamide (AC) OR 5-fluorouracil (FU)/epirubicin/ cyclophosphamide (FEC) in a similar dose and schedule as described in the protocol as part of neoadjuvant or adjuvant treatment. * For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception or 2 effective forms of non-hormonal contraception by the patient and/or partner. Contraception use must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment. Male patients should use condoms for the duration of the study. Specific country requirements will be followed. * Negative results of serum pregnancy test for premenopausal women of reproductive capacity and for women \< 12 months after menopause. * Patients may enroll before or after AC/FEC chemotherapy has completed. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate hematologic, biochemistry, and cardiac assessments. 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.