Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC)

Inclusion Criteria: * Invasive breast cancer of any receptor subtype diagnosed by core-needle biopsy * To undergo surgical resection with curative intent by partial mastectomy (lumpectomy) or mastectomy or * Triple negative breast cancer (defined by ER\<10%, PR\<10%, and HER2-negative by NCCN guidelines), T1c+ tumors for which neoadjuvant anthracycline-based and non-platinum containing chemotherapy is planned * Tumor \>5 mm in maximum diameter by ultrasound or mammography. (Subjects with smaller tumors may be included at the discretion of the Principal Investigator.) * Willing and able to provide written informed consent, including consent for use of available tissue and required blood draws for research purposes * Availability of at least one tumor-bearing core specimen from the breast cancer diagnostic biopsy * Karnofsky Performance status (KPS) 70% or greater. * Female or male ≥18 years of age on day of signing informed consent. * Adequate organ function as defined by protocol specified lab results Exclusion Criteria: * Prior neoadjuvant systemic therapy is planned * Prior surgery, radiotherapy or chemotherapy for this cancer (other than core-needle biopsy) * Received an investigational agent within 4 weeks of the first dose of treatment. * Diagnosis of immunodeficiency or has received more than replacement doses of corticosteroids any other immunosuppressive therapy within 4 weeks of the first dose of treatment * Hypersensitivity to IRX 2, cyclophosphamide, indomethaci…