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
2 other identifiers
interventional
16
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2017
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2016
CompletedFirst Posted
Study publicly available on registry
November 1, 2016
CompletedStudy Start
First participant enrolled
February 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 13, 2019
CompletedResults Posted
Study results publicly available
January 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 25, 2025
CompletedDecember 3, 2025
November 1, 2025
2.3 years
October 28, 2016
May 23, 2022
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Establish the Safety of the IRX-2 Regimen When Administered Pre-operatively in Early Stage Breast Cancer (ESBC) Patients
The safety of IRX-2 will be determined by any surgical delays associated with administration of the study regimen.
Day 1 to Day 26
Secondary Outcomes (1)
Tumor Infiltrating Lymphocytes
At time of pre-surgical biopsy and time of tumor specimen resection at day 26
Other Outcomes (4)
Characterization of Peripheral Lymphocytes
Day 1 to Day 26
TIL Phenotype
Day 1 to 26
Intratumoral T-cell Clonality Response
Day 1-26
- +1 more other outcomes
Study Arms (2)
IRX-2 Regimen -Early Stage Breast Cancer
EXPERIMENTALEnrolled 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.
IRX-2 Regimen -Triple Negative Breast Cancer
EXPERIMENTALEnrolled 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.
Interventions
One tablet of omeprazole daily for 21 days
Daily multivitamin containing 15-30 mg of zinc for 21 days.
One dose of cyclophosphamide 300 mg/m2 IV infusion
Indomethacin 25 mg three times a day for 21 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Providence Health & Serviceslead
- Brooklyn ImmunoTherapeutics, LLCcollaborator
Study Sites (1)
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Related Publications (1)
Sanchez K, Kim I, Chun B, Pucilowska J, Redmond WL, Urba WJ, Martel M, Wu Y, Campbell M, Sun Z, Grunkemeier G, Chang SC, Bernard B, Page DB. Multiplex immunofluorescence to measure dynamic changes in tumor-infiltrating lymphocytes and PD-L1 in early-stage breast cancer. Breast Cancer Res. 2021 Jan 7;23(1):2. doi: 10.1186/s13058-020-01378-4.
PMID: 33413574DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. David B. Page
- Organization
- Earle A. Chiles Research Institute, Providence Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
David Page, MD
Providence Health & Services
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2016
First Posted
November 1, 2016
Study Start
February 9, 2017
Primary Completion
May 13, 2019
Study Completion
September 25, 2025
Last Updated
December 3, 2025
Results First Posted
January 30, 2024
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 5 years
- Access Criteria
- IPD will be accessed for data verification purposes only.
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.