A Phase II Trial Evaluating Stereotactic Ablative Radiotherapy for Primary and Regional Breast Tumors (SABR-PRIMeR)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Locoregional Control
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Contraindications to radiotherapy, including a history of SLE, systemic scleroderma, IPF, ataxia telangiectasia, pregnancy
- •Previous history of locoregional radiotherapy to the ipsilateral breast
研究组 & 干预措施
Treatment
SABR treatment to Whole breast +/- regional lymph nodes
干预措施: SABR (Radiation)
结局指标
主要结局
Locoregional Control
时间窗: 2 Years
Assess median, 1-year and 2-year locoregional control
次要结局
- Overall survival(2 Years)
- Progression Free Survival(2 Years)
- systemic therapy switch(2 Years)
- Adverse Events(2 Years)