Immune-checkpoint Blockade After Partial Breast Irradiation by Pembrolizumab in Early TNBC (KEY-MELT)

June 2, 2025 updated by: Sung Gwe Ahn, Gangnam Severance Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sung Gwe Ahn, M.D.,Ph.D.
  • Phone Number: +82220193370
  • Email: asg2004@yuhs.ac

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immunochemotherapy including pembrolizumab after 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pathologic complete response
Time Frame: Within 3 weeks after surgical treatment
Within 3 weeks after surgical treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gangnam Severance Hospital

Investigators

  • Principal Investigator: Sung Gwe Ahn, M.D.,Ph.D.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 16, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2033

Study Registration Dates

First Submitted

June 2, 2025

First Submitted That Met QC Criteria

June 2, 2025

First Posted (Actual)

June 10, 2025

Study Record Updates

Last Update Posted (Actual)

June 10, 2025

Last Update Submitted That Met QC Criteria

June 2, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2025-0070

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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