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Not yet recruiting NCT07011823

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

Phase II Interventional Triple-Negative Breast Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Partial breast-irradiation.
Who it may be relevant to
Registry conditions: Triple-Negative Breast Neoplasm. Basic parameters: from 20 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase II Trial of Immunochemotherapy and Partial Breast Irradiation in Early TNBC With Immune-cold Tumor Environment (KEY-MELT)

Overview

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.

Detailed description

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, under the supervision and management of breast surgery and medical oncology research teams, 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.

Pathological complete response status in surgical specimens will be confirmed and reported by the pathologist.

Pathological examination and spatial multiplex analysis will be performed on biopsy and surgical specimens to explore biomarkers with significant changes.

As secondary end-points, disease-free survival and overall survival will be assessed.

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.

Primary outcome measures

  • Pathologic complete response [Time frame: Within 3 weeks after surgical treatment]

Eligibility criteria

Inclusion criteria

  • 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
  • Patients with no prior history of chemotherapy or radiation therapy
  • Patients scheduled to receive partial breast irradiation
  • Patients with ECOG performance status of 0-2
  • Patients who voluntarily signed the informed consent form for study participation

Exclusion criteria

  • 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
  • Patients who have previously received chemotherapy and/or radiation therapy to the ipsilateral breast and chest prior to study participation
  • Patients unable to receive neoadjuvant chemotherapy and Pembrolizumab
  • Vulnerable research subjects who are unable to participate voluntarily in the study due to physical/mental disabilities

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Schmid P, Cortes J, Dent R, McArthur H, Pusztai L, Kummel S, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Im SA, Untch M, Fasching PA, Mouret-Reynier MA, Foukakis T, Ferreira M, Cardoso F, Zhou X, Karantza V, Tryfonidis K, Aktan G, O'Shaughnessy J; KEYNOTE-522 Investigators. Overall Survival with Pembrolizumab in Early-Stage Triple-Negative Breast Cancer. N Engl J Med. 2024 Nov 28;391(21):19 PMID 39282906

Identifiers

NCT: NCT07011823 · 3-2025-0070

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗