Neoadjuvant MEDI4736 Concomitant With Weekly Nab-paclitaxel and Dose-dense AC for Stage I-III Triple Negative Breast Cancer

Inclusion Criteria

• Newly diagnosed histologically confirmed stage I-III, ER, PR and HER2 negative invasive breast cancer as defined by the ASCO CAP guidelines for whom systemic chemotherapy would be indicated based on physician judgment following standard NCCN practice guidelines.
• Willing and able to provide written informed consent for voluntary participation in the trial.
• Willing to undergo a baseline tumor core needle biopsy and blood draws for correlative science studies.
• Eighteen years of age or older on the day of signing informed consent.
• Female subjects must either be of non-reproductive potential or must have a negative urine or serum pregnancy test upon study entry.
• Patients should have adequate organ function to tolerate chemotherapy, as defined by:
• peripheral granulocyte count of > 1,500/mm3
• platelet count > 100,000/mm3
• hemoglobin >9 g/dL
• total bilirubin < 1.5 x upper limit of normal (ULN)
• aspartate aminotransferase (AST) and alanine aminotransferase (ALT) each < 1.5 x ULN
• serum creatinine < 1.5 x ULN or serum creatinine clearance < 50mL/min
• INR/PT/PTT each < 1.5 x ULN
• TSH within normal limits

Exclusion Criteria

• Patients who underwent partial excisional biopsy or lumpectomy, segmental mastectomy or modified radical mastectomy or sentinel node.
• Patients for whom anthracycline, paclitaxel or antibody therapies are contraindicated.
• Patients with active autoimmune disease or documented autoimmune disease within 2 years. Patients with hypothyroidism that is clinically stable and have normal TSH levels with hormone replacement, or patients with vitiligo or psoriasis not requiring treatment remain eligible for the study.
• Active or prior documented inflammatory bowel disease (Crohn's disease, ulcerative colitis).
• Patients with known active hepatitis B or C or HIV infection or with history of tuberculosis.