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A Phase Ib, Open-Label Study Evaluating the Safety and Pharmacokinetics of Atezolizumab (Anti-PD-L1 Antibody) in Combination with Trastuzumab Emtansine or With Trastuzumab and Pertuzumab (With and Without Docetaxel) in Patients With HER2-Positive BReast Cancer and Atezolizumab With Doxorubicin and Cyclophosphamide in HER2-Negative Breast Cancer
A Phase Ib, Open-Label Study Evaluating the Safety and Pharmacokinetics of Atezolizumab (Anti-PD-L1 Antibody) in Combination with Trastuzumab Emtansine or With Trastuzumab and Pertuzumab (With and Without Docetaxel) in Patients With HER2-Positive BReast Cancer and Atezolizumab With Doxorubicin and Cyclophosphamide in HER2-Negative Breast Cancer
Men or women
Metastatic or locally advanced or recurrent breast cancer
If HER2 negative, no more than two prior chemotherapy lines in metastatic disease and no prior anthracycline
Must have prior treatment with a taxane and trastuzumab in any setting
If treated in 2nd line or later, must have progressive disease since last regimen
If treated in 1st line metastatic, must have progression within 6 months of completing adjuvant therapy
Tumor specimen must be obtained after the most recent breast cancer systemic therapy
ECOG PS 0-2
Measurable disease
LVEF >50% by ECHO or MUGA
Adequate labs
No known CNS disease except for treated asymptomatic supratentorial mets with no need for active steroids
No leptomeningeal disease
Primary- DLTs, Safety; Secondary- Anti-therapeutic antibody, VS results, number of cycles received, PK