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 \< 2 and HER2 copy number \< 4); estrogen receptor (ER) positivity is defined as 1% or greater
• •Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
• •Patients who are ER negative must have progressed through at least one prior chemotherapy regimen in the metastatic setting or within 12 months of their last adjuvant systemic treatment; patients who are ER positive must have progressed through standard hormone therapy options and have received at least one line of chemotherapy in the metastatic setting
• •Completion of prior chemotherapy systemic anticancer therapy at least 2 weeks prior to study entry
• •Radiation therapy must be completed at least 2 weeks prior to study entry; radiated lesions may not serve as measurable disease unless they have been radiated over 12 months prior to enrollment
• •Patients may have parenchymal brain metastases if stable (no evidence of progression) for at least 1 month after local therapy (radiation or surgery); leptomeningeal disease is excluded; must have completed any prescribed steroid taper
• •Patients may have had a prior diagnosis of cancer if it has been \> 5 years since their last treatment
• •Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
• •Absolute neutrophil count \>= 1,000/mcL
• •Platelets \>= 50,000/mcl
• •Total bilirubin =\< 1.5 times the institutional upper limit of normal (ULN) (or =\< 3 times ULN in case of liver metastasis)
• •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SPGT\]) =\< 2.5 X institutional ULN (or =\< 5 times ULN in case of liver metastasis)
• •Creatinine =\< 2 ng/ml
• •Females of child-bearing potential (FOCBP) and males must agree to use 2 methods of adequate contraception prior to study entry, for the duration of study participation, and for number (#) days following completion of therapy; should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• •* NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• •* Has not undergone a hysterectomy or bilateral oophorectomy
• •* Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 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