Меню
Набор скоро начнётся NCT07011823

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

Фаза II С лечением Triple-Negative Breast Neoplasm

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Partial breast-irradiation.
Кому может быть актуально
Состояния в реестре: Triple-Negative Breast Neoplasm. Базовые параметры: от 20 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Лучевая терапия 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.

Первичные конечные точки

  • Pathologic complete response [Срок оценки: Within 3 weeks after surgical treatment]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • 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

Идентификаторы

NCT: NCT07011823 · 3-2025-0070

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗