Clinical trial · Interventional

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

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

NCT07011823CI-TRIAL-00090785KEY-MELTnot yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Triple-Negative Breast Neoplasm	Triple-Negative Breast Carcinoma	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Partial breast-irradiation	Radiation	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Immunochemotherapy including pembrolizumab after partial breast-irradiation
description
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.
interventionNames
1. Radiation: Partial breast-irradiation

Primary outcomes (1)

measure
Pathologic complete response
timeFrame
Within 3 weeks after surgical treatment

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 20 Years

Show eligibility criteria text

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

References

Publications (1)

BACKGROUNDSchmid 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 39282906