Clinical Trial of Atezolizumab With Paclitaxel, Trastuzumab, and Pertuzumab in Patients With Metastatic HER-2 Positive Breast Cancer

Exclusion Criteria

• •Patients participating in another trial of an investigational agent within 4 weeks of the 1st dose of the study.
• •Patients with tumors that cannot be measured or clinically followed.
• •Patients who had received therapy for metastatic breast cancer (other than that described above).
• •Patients with active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 4 weeks prior to trial treatment.
• •Patients with any baseline grade 2 neuropathy.
• •Patients with known prior hypersensitivity reaction to any of the study drugs.
• •Active autoimmune disease that is requiring systemic treatment within the past 3 months or documented history of clinically active autoimmune disease that requires systemic corticosteroids or immunosuppressive therapy.
• •Diagnosis of immunosuppression or receiving steroid therapy or other immunosuppressive therapy within 4 weeks of the study.
• •Have evidence of interstitial lung disease or active, non-infectious pneumonitis.
• •Patients with human immunodeficiency virus (HIV1/2). An HIV test must be performed to confirm status prior to enrollment.
• •Patients who are carriers of hepatitis virus B and C. Hepatitis B and C testing must be performed to confirm status prior to enrollment.
• •Prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death 1 ligand (PDL-1), anti-PD-L2, anti-CD137 antibody, or anti-cytotoxic T-lymphocyte -associated antigen-4 (CTLA-4) antibody.
• •Pregnant, breastfeeding, or expecting to conceive within the projected time of the trial, starting with the pre-screening or screening visit and through 7 months after the last dose of trial treatment.
• •Active infection requiring systemic therapy.
• •Active substance abuse or psychiatric disorders.
• •The use of a RANKL inhibitor (denosumab) must be discontinued during the study. Bisphosphonate therapy is permitted.
• •The following treatments must be discontinued: Herbal Medications. Immunomodulatory agents, including but not limited to interferons or IL-2. Immunosuppressive medications, including but not limited to cyclophosphamide, azathioprine, methotrexate, and thalidomide. Systemic corticosteroids. Anti-TNF-α agents.
• •Any live, attenuated vaccine within 28 days prior to the first day of treatment or during study treatment, or unwillingness to avoid live, attenuated vaccines within 90 days following the last dose of atezolizumab.