Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC)
Condition: Breast Neoplasm; Breast Neoplasm, Male; Triple Negative Breast Cancer
MeSH terms: Breast Neoplasms; Neoplasms; Triple Negative Breast Neoplasms; Breast Neoplasms, Male
Intervention: Cyclophosphamide; Indomethacin; Omeprazole; Multivitamin
Intervention description: One dose of cyclophosphamide 300 mg/m2 IV infusion; Indomethacin 25 mg three times a day for 21 days; One tablet of omeprazole daily for 21 days; Daily multivitamin containing 15-30 mg of zinc for 21 days.
Intervention MeSH terms: Indomethacin; Cyclophosphamide; Omeprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Healthy volunteers: No
Keywords: Breast Cancer; Early Stage Breast Cancer; Male breast cancer; IRX-2; Immunotherapy; Triple Negative Breast Cancer

Summary:

      The goal of this study is assess the safety and tolerability of the IRX-2 regimen in patients
      with early stage breast cancer (ESBC) and to estimate the pathologic complete response rate
      to neoadjuvant anthracycline-based and non-platinum containing chemotherapy in patients with
      triple-negative breast cancer who have received the IRX-2 Regimen before chemotherapy.
    

Eligibility criteria:

        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, indomethacin, aspirin or ciprofloxacin.

          -  Chronic anticoagulation, not including aspirin, but including heparins, warfarin, oral
             anticoagulants or other platelet function inhibitors, that cannot, in the documented
             opinion of the investigator, safely be interrupted from at least 2 days prior to the
             initiation of the study regimen until after surgical resection of the tumor.

          -  Another malignancy that required active treatment within 6 months of the first dose of
             treatment

          -  History or current evidence of any condition, therapy, or laboratory abnormality that
             might confound the results of the trial, interfere with the subject's participation
             for the full duration of the trial, such that trial participation is not in the best
             interest of the subject, including but not limited to uncontrolled hypertension or
             clinically significant cardiovascular disease, myocardial infarction within the
             previous 3 months, active infection or pneumonitis or other pulmonary disease
             requiring systemic therapy, clinically significant gastritis or peptic ulcer disease
             (that would preclude the use of indomethacin), stroke of other symptoms of cerebral
             vascular insufficient within the last 3 months, autoimmune disease that has required
             systemic treatment within the past 2 years (other than hormone replacement doses), or
             uncontrolled psychiatric or substance abuse disorders.

          -  Pregnancy or lactation.

          -  Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active
             Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is
             detected).