Immune-checkpoint Blockade After Partial Breast Irradiation by Pembrolizumab in Early TNBC

A single-arm, single-institution study to induce phenotypic changes in the tumor microenvironment by delivering 8Gy partial breast irradiation in immune-cold triple-negative breast cancer confirmed by PD-L1 and TILs. Additional tissue biopsy will be performed following radiation therapy. Subsequently, neoadjuvant chemotherapy including Pembrolizumab will be administered to evaluate whether pathological complete response rates are improved.

NCT Number	NCT07011823
Lead Sponsor	Gangnam Severance Hospital
Conditions	Triple-Negative Breast Neoplasm
Enrollment	20 participants
Start Date	2025-07-16
Primary Completion	2027-07-31 (estimated)
Study Completion	2033-07-31 (estimated)
Updated on ClinicalTrials.gov	2025-06-10