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

This study is currently recruiting participants.
Verified March 2017 by Providence Health & Services
ClinicalTrials.gov Identifier:
First Posted: November 1, 2016
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
IRX Therapeutics
Information provided by (Responsible Party):
Providence Health & Services
October 28, 2016
November 1, 2016
March 3, 2017
February 9, 2017
April 2018   (Final data collection date for primary outcome measure)
Surgical Delays [ Time Frame: Day 1 to Day 26 ]
Number of surgeries delayed due to adverse events from the IRX-2 regimen
Same as current
Complete list of historical versions of study NCT02950259 on ClinicalTrials.gov Archive Site
Tumor Infiltrating Lymphocytes [ Time Frame: Day 26 ]
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
Same as current
  • Characterization of peripheral lymphocytes [ Time Frame: Day 1 to Day 26 ]
    Number of peripheral lymphocytes including activated T-cells, T-regulatory cells, natural killer (NK) cells, and myeloid cells
  • TIL phenotype [ Time Frame: Day 1 to 26 ]
    Changes in abundance of T-regulatory cells, activated T-cells, myeloid lineages and dendritic cells
  • Intratumoral T-cell response [ Time Frame: Day 1-26 ]
    change in T-cell clonal responses by T-cell receptor DNA deep sequencing
  • Intratumoral Immune Response [ Time Frame: Day 1-26 ]
    Characterization of intratumoral immune responses by RNA expression using the Nanostring PanCancer Immune panel and/or Prosigna tumor recurrence score
Same as current
Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC)
A Phase Ib Study to Assess the Safety, Tolerability and Immunologic Activity of Preoperative IRX 2 In Early Stage Breast Cancer
The goal of this study is assess the safety and tolerability of the IRX-2 regimen in patients with early stage breast cancer (ESBC).

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.

Eligible subjects will have early stage breast cancer of any receptor subtype, 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.

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.

Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Breast Neoplasm
  • Breast Neoplasm, Male
  • Drug: Cyclophosphamide
    One dose of cyclophosphamide 300 mg/m2 IV infusion
    Other Name: Cytoxan
  • Drug: Indomethacin
    Indomethacin 25 mg three times a day for 21 days
    Other Name: Indocin
  • Drug: Omeprazole
    One tablet of omeprazole daily for 21 days
    Other Name: Prilosec
  • Dietary Supplement: Multivitamin
    Daily multivitamin containing 15-30 mg of zinc for 21 days.
    Other Name: Vitamin
Experimental: IRX-2 Regimen
All enrolled subjects 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.
  • Drug: Cyclophosphamide
  • Drug: Indomethacin
  • Drug: Omeprazole
  • Dietary Supplement: Multivitamin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
November 2018
April 2018   (Final data collection date for primary outcome measure)

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
  • 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).
Sexes Eligible for Study: All
Child, Adult, Senior
Contact: David Page, MD 503-215-5696 David.Page2@providence.org
Contact: Nicole Moxon, RN 503-215-2619 Nicole.Moxon@providence.org
United States
IRX-2 2016-B ( Other Identifier: IRX Therapeutics )
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Providence Health & Services has agreed to allow IRX Therapeutics to have access PHI for auditing purposes. Any non-Providence Health & Services employee who will access PHI will be required to sign a confidentiality agreement and will not be permitted to remove PHI from Providence Health & Services.
Providence Health & Services
Providence Health & Services
IRX Therapeutics
Principal Investigator: David Page, MD Providence Health & Services
Providence Health & Services
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP