clinical trial · NCT05491226
Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation
Stephen Shiao·phase2·recruiting·n = 35
TNBC - Triple-Negative Breast CancerBreast CancerPembrolizumabRadiation TherapyAxatilimab
brief summary
This is an open-label prospective, single institution, Phase II study of pembrolizumab in combination with radiation therapy and CSF-1R inhibition in patients with high-risk TNBC. The primary objective is to assess the pathologic complete response (pCR) rate where pCR is defined as the absence of invasive disease in the breast and lymph nodes at the time of standard of care (SOC) treatment. Secondary objectives include evaluating the change in tumor infiltrating lymphocytes (TILs), safety and tolerability of the combination, progression-free survival, event-free survival, overall survival, and node clearance.
started
Nov 17, 2023
primary completion
Dec 1, 2026
completion
Dec 1, 2026
last updated
Apr 20, 2026
official title
IIT2021-01-Shiao-CSF1Ri: Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol