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

NCT02950259 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-12-03

Study results available
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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.

Conditions

Interventions

DRUG

Cyclophosphamide

One dose of cyclophosphamide 300 mg/m2 IV infusion

DRUG

Indomethacin

Indomethacin 25 mg three times a day for 21 days

DRUG

Omeprazole

One tablet of omeprazole daily for 21 days

DIETARY_SUPPLEMENT

Multivitamin

Daily multivitamin containing 15-30 mg of zinc for 21 days.

Sponsors & Collaborators

  • Brooklyn ImmunoTherapeutics, LLC

    collaborator INDUSTRY

  • Providence Health & Services

    lead OTHER

Principal Investigators

  • David Page, MD · Providence Health & Services

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-09
Primary Completion
2019-05-13
Completion
2025-09-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02950259 on ClinicalTrials.gov