NCT02950259

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-02-09
• Primary completion: 2019-05-13
• Completion: 2025-09-25
• First posted: 2016-11-01
• Last updated: 2025-12-03
• Results posted: 2024-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study