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Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation

Breast Cancer Clinical Trial

Official title:
IIT2021-01-Shiao-CSF1Ri: Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05491226
Study type Interventional
Source Cedars-Sinai Medical Center
Contact Clinical Trial Recruitment Navigator
Phone 310-423-2133
Email cancer.trial.info@cshs.org
Status Recruiting
Phase Phase 2
Start date November 17, 2023
Completion date December 1, 2025
View Details
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