Spots Global Cancer Trial Database for Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation
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Trial Identification
Brief Title: Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation
Official Title: IIT2021-01-Shiao-CSF1Ri: Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation
Study ID: NCT05491226
Study Description
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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Cedars-Sinai Medical Center, Los Angeles, California, United States
Contact Details
Name: Stephen L Shiao, MD, PhD
Affiliation: CSMC
Role: PRINCIPAL_INVESTIGATOR
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