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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age20+
SponsorGangnam Severance Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Breast cancer patients aged 20 years or older with clinical stage IIA or higher on imaging studies

Patients with triple-negative breast cancer confirmed on tissue biopsy

Cold immune tumor environment with tumor-infiltrating lymphocytes (TILs) <30% and PD-L1 Combined Positive Score (CPS) <10 on immunohistochemical staining of biopsy specimens

Patients with no prior history of breast cancer

Disqualifiers

Patients with non-triple-negative breast cancer on tissue biopsy

Patients scheduled for surgery without neoadjuvant chemotherapy

Patients with TILs ≥30% or PD-L1 CPS ≥10 on immunohistochemical staining of biopsy specimens (immune-hot tumor)

Patients with recurrent breast cancer or de novo stage IV disease

Trial design

Treatments tested in this trial

  • Partial breast-irradiation

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators