NCT00072852已完成2 期
Phase II Trial of Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 134
- 试验地点
- 67
- 主要终点
- To evaluate the safety and efficacy of Irinotecan in refractory breast cancer.
研究概览
简要总结
The purpose of this phase II, randomized, open-label clinical trial is to study 2 schedules of single-agent Irinotecan in women with metastatic breast cancer who have experienced failure of prior therapy with an anthracycline, a taxane, and capecitabine. Patients will receive Irinotecan capsules either once each day for 5 days, or once a day for 14 days in 3 week cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Women with diagnosis of primary adenocarcinoma of the breast
- •Presence of locally advanced or metastatic disease non-amenable to surgery or radiation therapy with curative intent
- •At least one measurable lesion >20mm (or >10 mm with spiral CT scan)
- •Must have received (and failed) prior treatment with an anthracycline, a taxane, and capecitabine in the adjuvant and/or advanced disease treatment setting
- •Women at least 18 years old, with performance status 0-2
排除标准
- •Prior treatment with another topoisomerase I inhibitor
- •Current enrollment in another clinical trial
结局指标
主要结局
To evaluate the safety and efficacy of Irinotecan in refractory breast cancer.
次要结局
未报告次要终点
研究者
研究点 (67)
Loading locations...
相似试验
终止
2 期
TACE With Irinotecan Drug-eluting Beads and Intravenous (IV) Cetuximab in Refractory Colorectal CancerColorectal CancerNCT01060423Hans-Joachim Schmoll, MD8
撤回
1 期
Venetoclax and Irinotecan in Relapsed/Refractory SCLCRelapsed Small Cell Lung CancerRefractory Small Cell Lung CarcinomaNCT04543916Virginia Commonwealth University
已完成
2 期
Irinotecan, Carboplatin, Bevacizumab in the Treatment of Patients With Extensive Stage Small Cell Lung CancerCarcinoma, Small Cell LungNCT00294931SCRI Development Innovations, LLC50
已完成
2 期
A Study to Investigate the Efficacy and Safety of Ivonescimab Combined With Irinotecan Liposome as Second-line Regimen for SCLCExtensive-stage Small-cell Lung CancerSmall-cell Lung CancerNCT06478043Zhejiang Cancer Hospital60
终止
1 期
Randomized Efficacy Study of TPI 287 to Treat Primary Refractory or Early Relapsed NeuroblastomaNeuroblastomaNCT01505608Giselle Sholler14