An Open-label, Multi-center Study of the Safety and Tolerability of the Combination of Trastuzumab-MCC-DM1 (T-DM1) With Docetaxel, and Potentially Pertuzumab, for Treatment for Patients With Advanced Breast Cancer

Inclusion Criteria:

- Adult patients, >/= 18 years of age

- ECOG performance status 0-1 (ECOG performance status of 2 will be allowed if only due
to debilitating bone disease)

- HER2-positive metastatic or locally advanced breast cancer

- For MBC (metastatic breast cancer) patients:

- documented metastatic or inoperable locally advanced (without meeting LABC criteria)
disease, amenable for treatment with docetaxel

- history of disease progression within 3 months prior to study entry

- For LABC (locally advanced breast cancer) patients:

- newly diagnosed locally advanced breast cancer, Stage IIIA-IIIC (AJCC staging system)

Exclusion Criteria:

- Pregnant or lactating women

- Significant cardiac disease

- Inadequate bone marrow, liver or renal function

- For MBC patients:

- patients must not have received radiotherapy for the treatment of metastatic or
locally recurrent/advanced disease other than for the relief of pain in progressing
metastatic bone lesions and/or brain metastases

- brain metastases that are untreated, symptomatic or require therapy to control
symptoms

- For LABC patients:

- clinically or radiologically detectable metastasis (M1 disease)

- patients for whom surgery as primary intent procedure is the best option to treat
their disease

- previous systemic or loco regional anti-cancer therapy for locally advanced disease