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

Phase 1 Completed 16 enrolled Providence Health & Services Brooklyn ImmunoTherapeutics, LLC · collab

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2017-02-09
Primary completion: 2019-05-13
Completion: 2025-09-25

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Background	Cyclophosphamide	Other / unclassified	300 mg/m2	Intravenous
Background	Indomethacin	Small molecule	25 mg	Oral
Background	Omeprazole	Other / unclassified	—	Oral

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

Summary

Timeline

Publications

Drugs

Indications