NCT06839547招募中不适用
A Prospective, Multicenter, Observational Cohort Study to Evaluate the Efficacy and Safety of a Novel Anti-tumor Drug as a Radiosensitizer in Patients With Advanced Breast Cancer Brain Metastasis.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月1日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Intracranial Progression-Free Survival
研究概览
简要总结
A prospective, multicenter, observational cohort study to evaluate the efficacy and safety of a novel anti-tumor drug as a radiosensitizer in patients with advanced breast cancer brain metastasis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Males or females who are at least 18 years of age on the day of signing the informed consent form.
- •Patients with advanced breast cancer that is inoperable and has metastasized to the brain, confirmed by histology or cytology.
- •Patients who are planned to receive, currently receiving, or have completed intracranial radiotherapy after discussion by a multidisciplinary team (MDT) at the stage of brain metastasis.
- •Patients who are planned or currently receiving a systemic treatment regimen with a novel anti-tumor drug selected by the physician, within 3 weeks before radiotherapy, during radiotherapy, or within 3 weeks after completion of radiotherapy. These drugs include:
- •ADC drugs (such as T-DXd, T-DM1, etc.), CDK4/6 inhibitors, TKI drugs (such as Pyrotinib, Tucatinib, etc.), Novel chemotherapy drugs (such as Utidelone, Irinotecan liposomes, etc.), Bevacizumab, PD-1/PD-L1 inhibitors, etc.
- •Patients with a traceable medical history during the treatment period.
- •Patients who are able to sign the informed consent form to participate in the study.
排除标准
- •The subject has leptomeningeal metastasis.
- •If the patient has concurrent brain metastasis, the neurological symptoms are too severe to cooperate with radiotherapy.
- •The subject has not signed the informed consent form.
- •Pregnant or breastfeeding women.
- •Other situations deemed by the investigator as unsuitable for inclusion in the study.
结局指标
主要结局
Intracranial Progression-Free Survival
时间窗: 24 months
The time from the randomization of the subject to the first documented tumor progression (PD) or death due to any cause.
次要结局
未报告次要终点
研究者
Ma Fei，MD
Deputy Director of the Department of Medical Oncology
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
研究点 (1)
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