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

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.

Inclusion Criteria:
• Invasive breast cancer of any receptor subtype diagnosed by core-needle biopsy
• To undergo surgical resection with curative intent by partial mastectomy (lumpectomy) or mastectomy
• Tumor >5 mm in maximum diameter by ultrasound or mammography. (Subjects with smaller tumors may be included at the discretion of the Principal Investigator.)

Phase Ib
David Page, M.D.
Earle A Chiles Research Institute (EACRI)
Nikki Moxon
  • Oncology and Hematology Care Eastside
  • Oncology and Hematology Care Westside