MEDI4736 and Tremelimumab in Treating Patients With Metastatic HER2 Negative Breast Cancer

Inclusion Criteria

• Patients must have a histologically documented (either primary or metastatic site) diagnosis of breast cancer that is HER2 non-overexpressing by immunohistochemistry, namely 0 or 1; if they have an equivocal immunohistochemistry, 2, the tumor must be non-gene amplified by fluorescence in situ hybridization (FISH) performed upon the primary tumor or metastatic lesion (ratio 5 years since their last treatment
• Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of = = 1,000/mcL
• Platelets >= 50,000/mcl
• Total bilirubin = 12 months)
• FOCBP must have a negative pregnancy test within 7 days prior to registration on study
• Willingness to provide a fresh biopsy prior to study enrollment and after 2 cycles of treatment
• Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

Exclusion Criteria

• Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier are not eligible.
• Current or prior use of immunosuppressive therapy within 2 weeks of starting investigational therapy
• Patients who are taking any herbal (alternative) medicines are NOT eligible for participation; patients must be off any such medications by the time of registration for at least 2 weeks; NOTE: Vitamin supplements are acceptable
• Patients may not have received any other investigational agents within 4 weeks prior to registration
• Prior treatment with immune therapy (including but not limited to cluster of differentiation [CD]137, OX40, programmed death [PD]-1, PD-L1 or cytotoxic T-lymphocyte antigen 4 [CTLA4] inhibitors)
• Prior severe infusion reaction to a monoclonal antibody
• Patients with a history of or active autoimmune disease within the past 3 years with the following exceptions:
• Vitiligo or alopecia
• Hypothyroidism on stable doses of thyroid replacement therapy
• Psoriasis not requiring systemic therapy within the past 3 years
• History of primary immunodeficiency disease or tuberculosis
• Major medical conditions that might affect study participation (uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection) are not eligible; other significant comorbid condition which the investigator feels might compromise effective and safe participation in the study
• Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:
• Uncontrolled pulmonary, renal, or hepatic dysfunction
• Ongoing or active infection requiring systemic treatment
• Known active or chronic viral hepatitis or human immunodeficiency virus (HIV)
• Psychiatric illness/social situations that would limit compliance with study requirements
• Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
• Female patients who are pregnant or nursing are not eligible