NCT01077726已完成2 期
A Single Arm, Open-label Trial Assessing the Effect of Capecitabine (Xeloda® ) on Progression-free Survival Rate at Four Months in Breast Cancer Patients With CNS Progression After Whole Brain Radiotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
- 主要终点
- Progression-free survival
研究概览
简要总结
This single arm study will assess the efficacy of Xeloda in the treatment of brain metastases in breast cancer patients with central nervous system (CNS) progression after whole brain radiotherapy. Patients will receive xeloda 1000mg/m2 po bid on days 1-14 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients, >=18 years of age;
- •breast cancer;
- •CNS progression after radio-surgery + whole brain radiotherapy, or whole brain radiotherapy alone;
- •at least one measurable lesion;
- •ECOG performance status 0-2.
排除标准
- •prior systemic treatment of brain metastases;
- •prior disease progression while on Xeloda treatment;
- •previous history of cancer (other than curatively treated basal and squamous cell cancer of the skin or in situ cancer of the cervix) in previous 5 years;
- •clinically significant cardiovascular disease.
研究组 & 干预措施
1
Experimental
干预措施: capecitabine [Xeloda] (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 4 months
次要结局
- Objective Central Nervous System (CNS) response(From first administration of study treatment until documented CNS recurrence or progression)
- Progression-free survival\n(From the first administration of study treatment to the time of documented recurrence or progression\n)
- Cranial PFS(From the first administration of study treatment to the time of documented cranial recurrence or progression\n)
- Clinical benefit \n(From first administration of study treatment to study end (12 Months))
- Duration of CNS response(From time of first documented cranial complete response (CR) or partial response (PR) (whichever is recorded first) until the first date CNS recurrence or progression is documented)
- Extra-cranial disease response rate\n(From first administration of study treatment to the time of documented extra-cranial recurrence or progression)
- Overall Survival (OS)\n(From first administration of study treatment to the time of death from any cause)
研究者
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