M7824 in Treating Patients With Stage II-III HER2 Positive Breast Cancer

Inclusion Criteria

• •Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act \[HIPAA\]) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
• •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• •Tumor size \>= 2 cm and with no known distant metastatic disease
• •HER2+, breast cancer as defined by American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines: HER2/neu is defined as positive: immunohistochemistry (IHC) 3+ based on circumferential membrane staining that is complete, intense in situ hybridization (ISH) positive based on: single-probe average HER2 copy number \>= 6.0 signals/cell. Dual-probe HER2/CEP17 ratio \>= 2.0; with an average HER2 copy number \>= 4.0 signals/cell, dual-probe HER2/CEP17 ratio \>= 2.0; with an average HER2, copy number \< 4.0 signals/cell, dual-probe HER2/CEP17 ratio \< 2.0; with an average HER2, copy number \>= 6.0 signals/cell, neoadjuvant systemic therapy is planned and will include HER2 targeted therapy in combination with chemotherapy of physician's choice
• •Hemoglobin \>= 9 g/dL
• •Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (\>= 1500 per mm\^3)
• •Platelet count \>= 100 x 10\^9/L (\>= 100,000 per mm\^3)
• •Serum bilirubin =\< 1.5 x institutional upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only upon treating physician, principal investigator (PI) or co-PI approval
• •Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal
• •Serum creatinine clearance \>= 60 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
• •Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: \>= 60 years old and no menses for \>= 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry and be using highly effective contraception (that is, methods with a failure rate of less than 1% per year) for both male and female subjects if the risk of conception exists (Note: The effects of the trial treatment on the developing human fetus are unknown; thus, women of childbearing potential and men must agree to use highly effective contraception). Male subjects on study must also use highly effective contraception. Highly effective contraception must be used 30 days prior to first trial treatment administration, for the duration of trial treatment, and at least for 4 months after stopping trial treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this trial, the treating physician should be informed immediately
• •Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up