Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation
Status:
Not yet recruiting
Trial end date:
2024-10-01
Target enrollment:
Participant gender:
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.