Clinical Research Directory
Browse clinical research sites, groups, and studies.
Immune-checkpoint Blockade After Partial Breast Irradiation by Pembrolizumab in Early TNBC
Sponsor: Gangnam Severance Hospital
Summary
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.
Official title: Phase II Trial of Immunochemotherapy and Partial Breast Irradiation in Early TNBC With Immune-cold Tumor Environment (KEY-MELT)
Key Details
Gender
FEMALE
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-07-16
Completion Date
2033-07-31
Last Updated
2025-06-10
Healthy Volunteers
No
Conditions
Interventions
Partial breast-irradiation
First, 8Gy partial breast irradiation will be delivered in immune-cold triple-negative breast cancer (TNBC) confirmed by PD-L1 and TILs. Sequentially, standard neoadjuvant chemotherapy for triple-negative breast cancer including pembrolizumab, paclitaxel, carboplatin, doxorubicin, and cyclophosphamide (KeyNote-522 regimen) will be administered, followed by surgical treatment.