Clinical Trials /

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

NCT02950259

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC)
  • Official Title: A Phase Ib Study to Assess the Safety, Tolerability and Immunologic Activity of Preoperative IRX 2 In Early Stage Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: 16-126B
  • SECONDARY ID: IRX-2 2016-B
  • NCT ID: NCT02950259

Conditions

  • Breast Neoplasm
  • Breast Neoplasm, Male
  • Triple Negative Breast Cancer

Interventions

DrugSynonymsArms
CyclophosphamideCytoxanIRX-2 Regimen -Early Stage Breast Cancer
IndomethacinIndocinIRX-2 Regimen -Early Stage Breast Cancer
OmeprazolePrilosecIRX-2 Regimen -Early Stage Breast Cancer

Purpose

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.

Detailed Description

      This will be a Phase Ib study conducted to determine the safety and tolerability of an IRX-2
      regimen in ESBC, to be administered pre-operatively before standard-of-care surgical
      resection and following standard-of-care diagnostic biopsy. This study will also include
      triple-negative breast cancer patients who will receive the IRX-2 regimen prior to
      chemotherapy.

      Eligible subjects will have early stage breast cancer of any receptor sub-type, for which
      standard-of-care surgical resection is planned. To be eligible, a minimum of 1 core of
      tumor-bearing biopsy material must be available for research analysis.

      Cohort B will enroll subjects 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. The IRX-2 regimen will be administered and
      completed preceding chemotherapy. Cohort B subjects must undergo post-IRX-2 Regimen biopsy
      (2-3 cores), followed by commencement of chemotherapy preferably within one week after
      biopsy.

      The IRX-2 regimen will be administered in all enrolled subjects. IRX 2 will be administered
      by subcutaneous injection into the periareolar skin of the affected breast.
    

Trial Arms

NameTypeDescriptionInterventions
IRX-2 Regimen -Early Stage Breast CancerExperimentalEnrolled subjects with early stage breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.
  • Cyclophosphamide
  • Indomethacin
  • Omeprazole
IRX-2 Regimen -Triple Negative Breast CancerExperimentalEnrolled subjects with triple negative breast cancer will receive a single dose of cyclophosphamide (300 mg/m2) by IV infusion on Day 1. Also starting on Day 1 and continuing until Day 21, subjects will take daily oral indomethacin (25 mg three times each day), daily oral omeprazole (one tablet) and daily oral multivitamin containing 15-30 mg of zinc. On any 10 consecutive day period between Days 4-17, patients will receive two 1 mL subcutaneous periareolar injections of IRX-2.
  • Cyclophosphamide
  • Indomethacin
  • Omeprazole

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).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:N/A
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Surgical Delays
Time Frame:Day 1 to Day 26
Safety Issue:
Description:Number of surgeries delayed due to adverse events from the IRX-2 regimen

Secondary Outcome Measures

Measure:Tumor Infiltrating Lymphocytes
Time Frame:Day 26
Safety Issue:
Description:Change in tumor infiltrating lymphocyte (TIL) score as measured by H&E TIL count according to Salgado criteria from pre-surgical biopsy to resected tumor specimen

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Providence Health & Services

Trial Keywords

  • Breast Cancer
  • Early Stage Breast Cancer
  • Male breast cancer
  • IRX-2
  • Immunotherapy
  • Triple Negative Breast Cancer

Last Updated

December 27, 2017