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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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).

Detailed Summary:

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.

Eligible subjects will have early stage breast cancer of any receptor subtype, 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.

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.


Sponsor: Providence Health & Services

Current Primary Outcome: Surgical Delays [ Time Frame: Day 1 to Day 26 ]

Number of surgeries delayed due to adverse events from the IRX-2 regimen


Original Primary Outcome: Same as current

Current Secondary Outcome: Tumor Infiltrating Lymphocytes [ Time Frame: Day 26 ]

Change in tumor infiltrating lymphocyte (TIL) score as measured by H&E TIL count according to Salgado criteria from pre-surgical biopsy to resected tumor specimen


Original Secondary Outcome: Same as current

Information By: Providence Health & Services

Dates:
Date Received: October 28, 2016
Date Started: February 9, 2017
Date Completion: November 2018
Last Updated: March 1, 2017
Last Verified: March 2017