Trial of Pembrolizumab/Chemotherapy With Live Biotherapeutic Product, MO-03, in Patients With Early Stage Triple Negative Breast Cancer

Inclusion Criteria: * Female or male age ≥ 18 years of age. * Patients with high-risk early stage triple negative breast cancer. Triple negative status will be defined as ER≤10%, PR≤10%, HER2 negative (by FISH) per ASCO-CAP guidelines. * Clinically staging T1c any N M0 or any T N1-3 M0. * Willing to provide FFPE from baseline standard of care biopsy and post-treatment residual tumor at the time of surgery. * ECOG 0-1 * Patients must have adequate organ function as defined in the following. Specimens must be collected within 28 days prior to the start of study treatment. * For patients who will receive regimen 1 only: Participants must have adequate cardiac function. Participants must have left ventricular ejection fraction ≥ 50% as assessed by either ECHO or MUGA within 28 days prior to the start of treatment. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must be class 2B or better. * Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 28 days of the start of treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. * Male participants: A male participant must agree to use a contraception as detailed in Appendix B of this protocol during the treatment period and for at least 1…