CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Cyclophosphamide +3 moredrug
Likely dose
Cyclophosphamide 300 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02950259
NCT02950259Phase 1Completed
CompareCT.gov

A Phase Ib Study to Assess the Safety, Tolerability and Immunologic Activity of Preoperative IRX 2 In Early Stage Breast Cancer

Providence Health & Services·interventional·Posted Nov 1, 2016·Updated Dec 3, 2025

In Brief

A Phase 1 clinical trial evaluating Cyclophosphamide, Indomethacin, and 2 other interventions for Breast Neoplasm and 2 related conditions. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasm, Breast Neoplasm, Male, Triple Negative Breast Cancer
CountriesUnited States
CollaboratorsBrooklyn ImmunoTherapeutics, LLC

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 1, 2016
Enrollment StartFeb 9, 2017
Primary CompletionMay 13, 2019
Study CompletionSep 25, 2025
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.7 years ago

Interventions

Cyclophosphamidedrug

One dose of cyclophosphamide 300 mg/m2 IV infusion

Indomethacindrug

Indomethacin 25 mg three times a day for 21 days

Omeprazoledrug

One tablet of omeprazole daily for 21 days

Multivitamindietary

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