Concomitant Radiotherapy and New Drugs in Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Toxicity of Radiotherapy Treatments
研究概览
简要总结
The primary objective of the study is to describe the tolerance profile of radiation treatments performed during systemic treatment with new drugs (molecular targeted therapies, immunotherapy, others).
详细描述
Patients suffering from stage IV breast cancer undergoing a systemic treatment including: molecular targeted therapy, conjugated antibodies (ADCs), monoclonal antibodies, tyrosine kinase inhibitors (TKI), immunotherapy (ICIs), who are candidates for a radiation treatment (both palliative or curative), after being informed about the study and giving written informed consent, will be considered eligible for this observational study. This study aims to prospectively analyze the tolerance profile of radiation treatments performed during new generation systemic therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Patients suffering from stage IV breast cancer
- •Ongoing systemic treatment including: molecular targeted therapy, conjugated antibodies, monoclonal antibodies, tyrosine kinase inhibitors, immunotherapy (immunocheckpoint inhibitors)
- •Candidates for radiation treatment (both palliative and curative).
排除标准
- •Previous radiation treatment on the same site
- •Absolute contraindications to radiotherapy
- •Systemic treatment administered as part of a clinical trial
结局指标
主要结局
Toxicity of Radiotherapy Treatments
时间窗: Baseline, at 3, 6 month, one year from the end of radiation treatment, then yearly up to 3 years
Acute and Late Toxicity evaluated with CTCAE (Common Terminology Criteria for Adverse Events) scale v6.0
次要结局
- Response to Radiotherapy treatments with curative intent(evaluated at 3 months, 6 months, 1 year from treatments)
- Pain response to Radiotherapy treatments with palliative intent(evaluated at 3 and 6 months after treatments)
- Progression free survival (PFS)(every 3 months after radiation treatments)