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