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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
Primary tumor size >2cm
Stage at presentation cT2-cT4, cN0-cN3, cM0
HER2 positive disease (ISH positive and/or 3+ by IHC)
HLA-A2 positive (by central laboratory)
ECOG PS 0-2
Adequate lab tests
Baseline LVEF >50% by ECHO or MUGA
No prior systemic therapy for treatment or prevention of breast cancer
No history of DCIS unless >5 years prior to current diagnosis
No Grade 2 or higher peripheral neuropathy
No history of autoimmune disease, need for current immunosuppressants
No HBV/HCV/HIV
Primary- DLTs, Safety; Secondary- Anti-therapeutic antibody, VS results, number of cycles received, PK