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NOT YET RECRUITING
NCT07011823
PHASE2

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

Sponsor: Gangnam Severance Hospital

View on ClinicalTrials.gov

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

Interventions

RADIATION

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.