NCT07011823

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
88mo left

Started Jul 2025

Longer than P75 for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Jul 2025Jul 2033

First Submitted

Initial submission to the registry

June 2, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 16, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2033

Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

June 2, 2025

Last Update Submit

June 2, 2025

Conditions

Triple-Negative Breast Neoplasm

Keywords

Immune-cold microenvironmentTriple-negative breast cancerPartial Breast IrradiationPembrolizumabKeyNote-522Immunochemotherapy

Outcome Measures

Primary Outcomes (1)

  • Pathologic complete response

    Within 3 weeks after surgical treatment

Study Arms (1)

Immunochemotherapy including pembrolizumab after partial breast-irradiation

EXPERIMENTAL

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

Interventions

Partial breast-irradiationRADIATION

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.

Immunochemotherapy including pembrolizumab after partial breast-irradiation

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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):1981-1991. doi: 10.1056/NEJMoa2409932. Epub 2024 Sep 15.

    PMID: 39282906BACKGROUND

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sung Gwe Ahn

    M.D.,Ph.D.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung Gwe Ahn, M.D.,Ph.D.

CONTACT

+82220193370asg2004@yuhs.ac

Soong June Bae, M.D.,Ph.D.

CONTACT

mission815815@yuhs.ac

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 2, 2025

First Posted

June 10, 2025

Study Start

July 16, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2033

Last Updated

June 10, 2025

Record last verified: 2025-06