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Набор скоро начнётся NCT06937281

SABR PRIMER - Evaluating Stereotactic Ablative Radiotherapy for Primary and Regional Breast Tumors

Без фазы С лечением Breast Cancer Metastases

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: SABR.
Кому может быть актуально
Состояния в реестре: Breast Cancer, Metastases. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Официальное название

A Phase II Trial Evaluating Stereotactic Ablative Radiotherapy for Primary and Regional Breast Tumors (SABR-PRIMeR)

Обзор

The study is being done to determine if stereotactic ablative radiotherapy (SABR) can control tumour growth for patients with metastatic breast cancer. Secondary objectives will be overall survival, progression-free survival and time to switch of next line of systemic therapy. Radiation-related adverse events will be assess, with a specific focus on dermatitis, lymphedema and brachial plexopathy. The exploratory objective is to correlate toxicities and outcomes with peripheral blood biomarkers and circulating tumor DNA to potentially help predict responses in future patients receiving combined therapy.

Подробное описание

Purpose:

The purpose of this study is to determine if stereotactic ablative radiotherapy (SABR) can provide effective locoregional control for patients with metastatic breast cancer. As secondary objectives, the investigators will assess the overall survival, progression-free survival and time to switch of next line of systemic therapy. The investigators will also assess radiation-related adverse events using CTCAE v5.0, with a specific focus on dermatitis, lymphedema and brachial plexopathy. Finally, as an exploratory objective, the investigators aim to correlate toxicities and outcomes with peripheral blood biomarkers and circulating tumor DNA to potentially help predict responses in future patients receiving combined therapy.

Primary Objective:

• Assess median, 1-year and 2-year locoregional control

Secondary Objectives:

* Assess median, 1-year and 2-year overall survival * Assess median, 1-year and 2-year progression-free survival * Assess median time to systemic therapy switch * Assess radiation-related adverse events using CTCAE v5.0

Correlative Objectives:

• Correlate outcomes with peripheral blood-derived parameters

Research Design The trial is designed as a single-arm interventional study investigating stage IV breast cancer with persistent or progressive locoregional disease despite the use of standard systemic therapy A retrospective study will be conducted to create a matched cohort to compare locoregional control rates with patients who received conventional fractionated radiotherapy.

Вмешательства

  • Лучевая терапия SABR
    Prescription dose/fractionation: 26Gy/5 with 40Gy/5 +/- 35Gy/5 Boost Radiation Technique: VMAT Treatment Frequency: Every other day (EOD)

Первичные конечные точки

  • Locoregional Control [Срок оценки: 2 Years]
Вторичные конечные точки (4)
  • Overall survival [Срок оценки: 2 Years]
  • Progression Free Survival [Срок оценки: 2 Years]
  • systemic therapy switch [Срок оценки: 2 Years]
  • Adverse Events [Срок оценки: 2 Years]

Критерии участия

Критерии включения

  • Pathologically confirmed AJCC 7th/8th edition Stage IV invasive ductal carcinoma or invasive lobular carcinoma of the breast.
  • Measurable disease in the breast, suitable to receive radiotherapy.
  • Receiving or planned to receive systemic therapy.

a. The following should be held for the duration of treatment: cytotoxic chemotherapy, CDK4/6 inhibitors, T-DXd

  • Patients are allowed to have SABR for oligometastatic disease as clinically indicated
  • Age 18 or older
  • ECOG Performance Status 0-2
  • Life expectancy greater than 6 months
  • Able and willing to provide informed consent
  • Able to complete patient reported outcome questionnaires

Критерии исключения

  • Contraindications to radiotherapy, including a history of SLE, systemic scleroderma, IPF, ataxia telangiectasia, pregnancy
  • Previous history of locoregional radiotherapy to the ipsilateral breast

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • BC Cancer - Vancouver — Vancouver

Идентификаторы

NCT: NCT06937281 · H25-00274

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗