NCT02253459已完成3 期
Phase III Clinical Trials of UTD1 Injection Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced and Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 405
- 试验地点
- 11
- 主要终点
- Progresssion free survival (PFS)
研究概览
简要总结
The purpose of this study is to determine whether UTD1 Injection in combination with capecitabine is effective in the treatment of advanced metastatic breast cancer using capecitabine as a control.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically and/or cytologically diagnosed patients with advanced, metastatic breast cancer,or lacking standard therapy or being failed to or recurrent after standard therapy;
- •Patients who have previously treated with ≤4 chemotherapeutic regimes;
- •Patients who have previously treated with an anthracyclin antibiotics and a taxane;
- •Age 18 -70 years old, ECOG performance status of 0-2; Life expectancy of 3 months or more;
- •Patients with at least 1 measurable target lesion determined by CT within 2 weeks prior to enrollment;
- •Neuropathy <CTC2 degree （NCI CTC4.03）within 4 weeks prior to enrollment;
- •Basically normal results from routine blood test within 1 week prior to enrollment;
- •Basically normal liver and renal functions within 1 week prior to enrollment;
- •No abnormal function for major internal organs, no heart diseases.
排除标准
- •Received chemotherapy, radiotherapy, therapies with hormones or molecularly targeted drugs 4 weeks prior to enrollment, or received other chemotherapies while participating in this trial;
- •Patients with documented hypersensitivity to Cremophor EL, or patients with previous taxane treatment related SAE;
- •Patients of pregnancy or breast feeding;
- •Patients with previous standard capecitabine treatment ineffective, or patients received standard capecitabine treatment effective, but with less than 6 months of capecitabine clearance period;
- •Patients with uncontrolled brain metastasis or bone metastasis, which plan for recent surgery or local radiotherapy, or other emergency treatment;
- •Patients combined with severe and /or uncontrolled medical conditions, including severe cardiovascular disease, uncontrolled diabetes and high blood pressure, severe infection, severe gastrointestinal ulceration, and patients with incontrollable psychiatric history;
- •Patients with poor compliance;
- •Patients not fitted for this study determined by the investigators.
研究组 & 干预措施
UTD1 Injection plus capecitabine
Experimental
UTD1 Injection: 30 mg/m2/day, IV on day 1-day 5 of each 21 day cycle; Capecitabine: 2000 mg/m2/day, oral bid on day 1-day 14 of each 21 day cycle.
Number of Cycles: until progression or unacceptable toxicity develops.
干预措施: UTD1 Injection plus capecitabine (Drug)
capecitabine
Active Comparator
Capecitabine: 2500 mg/m2/day, oral bid on day 1-day 14 of each 21 day cycle.
Number of Cycles: until progression or unacceptable toxicity develops.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Progresssion free survival (PFS)
时间窗: 2.0 years
次要结局
- Overall survival (OS)(4 years)
- Objective Response Rate(ORR）(1.5 years)
研究者
研究点 (11)
Loading locations...
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