RWF_16-126

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
NCT02950259
Cancer, All Other
Breast
David Page, M.D.
Earle A Chiles Research Institute (EACRI)
Nikki Moxon
  • Oncology and Hematology Care Eastside