Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer

Inclusion Criteria: Triple Negative Cohort: * Histologically proven invasive breast cancer. * Primary tumor must be ER-negative (ER in \<1% of cells), PR-negative (PR in \<1% of cells), and HER2-negative (0-1+ by IHC or FISH ratio\<2.0 with signal number \<6/cell), or consistent with contemporary NCCN guidelines (https://www.nccn.org/). * Patients must be high risk, defined as either: * Pathologic stage IIA, IIB, IIIA, IIIB, or IIIC by AJCC 8, or * Residual invasive cancer in breast or regional nodes following preoperative chemotherapy. * Patients must have no convincing evidence of recurrent disease based on one of the following: * bone scan and imaging scans of the chest/abdomen/pelvis or * FDG PET scan. * ≥1 months since last active therapy (chemotherapy, radiation therapy, or surgery) and ≤ 36 months since the initiation of treatment for the current cancer, based on the period of highest risk for patients with Stages I-III triplenegative breast cancer \[33, 34\]. * Treatment prior to enrollment must be consistent with NCCN guidelines extant at the time treatment was given, found at: https://www.nccn.org/. * Age greater than or equal to 18 years. * ECOG Performance Status 0-1. * Adequate major organ function, defined as: WBC ≥ 3,000/mcl, hemoglobin ≥ 10.0 gm/dL, platelets ≥ 100,000/mcL, total bilirubin within normal limits, ALT/AST \<3 x upper limits of normal (ULN), serum creatinine ≤ 1.5 x ULN. * Serum prolactin level must be ≤ upper limits of normal (ULN). * Subject…