Pembrolizumab and Binimetinib in Treating Patients With Locally Advanced or Metastatic Triple Negative Breast Cancer

Inclusion Criteria

• Age >= 18 years
• Histological confirmation of adenocarcinoma of the breast
• Estrogen receptor (ER) and progesterone receptor (PR) negative; defined as ER = 10% of the invasive tumor cell; OR
• IHC grade 2+ staining intensity by means of IHC analysis with no gene amplification below; OR
• No gene amplification on in situ hybridization (ISH) based on:
• Single-probe average HER2 copy number = 9.0 g/dL (must be >= 7 days after most recent transfusion) (obtained = = 1500/mm^3 or >= 1.5 x 10^9/L (obtained = = 100,000/mm^3 or >= 100 x 10^9/L (must be >= 7 days after most recent transfusion) (obtained = = 50 ml/min using the Cockcroft-Gault formula (obtained = = 50% as determined by multigated acquisition (MUGA) scan or echocardiogram (echo)
• Corrected QT (QTc) interval = = 9.0 g/dL (must be >= 7 days after most recent transfusion) (obtained = = 1500/mm^3 or >= 1.5 X 10^9/L (obtained = = 100,000/mm^3 or >= 100 X 10^9/L (must be >= 7 days after most recent transfusion) (obtained = = 50 ml/min using the Cockcroft-Gault formula (obtained = 4 weeks prior to registration
• Prior therapy including chemotherapy, targeted small molecule therapy or radiation therapy = 4 weeks prior to registration; NOTE: exception for neuropathy = = 4 weeks and patients must be off corticosteroid therapy for >= 3 weeks; NOTE: carcinomatous meningitis is excluded regardless of clinical stability
• Active autoimmune disease requiring systemic treatment in the past 2 years (i.e. use of disease modifying agents, corticosteroids or immunosuppressive drugs); NOTE: replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
• Known history of, or any evidence of active, non-infectious pneumonitis
• Active infection requiring systemic therapy
• Known history of acute or chronic pancreatitis
• History of or current evidence of retinal vein occlusion (RVO) or predisposing factors to RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes)
• History of retinal degenerative disease
• History of Gilbert's syndrome
• Other active malignancy = = 150 mmHg or diastolic blood pressure >= 100 mmHg despite medical treatment
• History of neuromuscular disorders that are associated with elevated creatine kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
• Planning to embark on a new strenuous exercise regimen after first dose of study treatment; NOTE: muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided while on binimetinib treatment
• Impairment of gastrointestinal function or gastrointestinal disease (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection); NOTE: gastric bypass is allowed
• Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/psychological issues, etc.
• Major surgery =< 3 weeks prior to registration or failure to adequately recover from surgery
• Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
• RETREATMENT REGISTRATION: Received any type anti-cancer treatment since the last dose of pembrolizumab
• RETREATMENT REGISTRATION: History or current evidence of any condition, therapy, or laboratory abnormality that might interfere with subject's participation for the full duration of the trial or is not in the best interest of the subject to participate, in the opinion