Study With Atezolizumab in Combination With Trastuzumab and Vinorelbine in HER2-positive Advanced/Metastatic Breast Cancer

Exclusion Criteria

• •Treatment with any investigational anticancer drug within 14 days of the start of study treatment.
• •Patient has received Vinorelbine or any other vinca alkaloids previously immediately prior to initiate study treatment.
• •History of other malignant tumors in the past 3 years
• •Known or suspected leptomeningeal disease (LMD)/ poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain metastases.
• •Symptomatic hypercalcemia requiring treatment with bisphosphonates in the 14 days prior to inclusion
• •Cardiopulmonary dysfunction
• •Any other severe, uncontrolled
• •Major surgery in the 28 days prior to enrolment
• •Infection with HIV or active Hepatitis B and/or Hepatitis C.
• •History of trastuzumab intolerance, including grade 3-4 infusion reaction or hypersensitivity.
• •Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
• •History of autoimmune disease,
• •Prior allogeneic stem cell or solid organ transplantation
• •History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan. (Note: History of radiation pneumonitis in the radiation field \[fibrosis\] is permitted.)
• •Active tuberculosis
• •Receipt of a live, attenuated vaccine within 4 weeks prior to enrollment
• •Prior treatment with CD137 agonists, anti-PD-1, or anti-PD-L1 therapeutic antibody or immune checkpoint targeting agents
• •Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin \[IL\]-2) within 4 weeks or five half-lives of the drug prior to enrolment
• •Treatment with systemic immunosuppressive medications within 2 weeks prior to enrolment, or anticipated requirement for systemic immunosuppressive medications during the trial.