NCT00494481已完成2 期
A Phase II, Double-blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of ZD6474 in Combination With Docetaxel (Taxotere™) vs Docetaxel Alone as 2nd Line Treatment for Advanced Breast Cancer (ABC).
Genzyme, a Sanofi Company2 个研究点 分布在 2 个国家目标入组 64 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Number of Patients With a Disease Progression Event
研究概览
简要总结
To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using the progression event count methodology
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Females with histological/cytological confirmation of breast cancer.
- •Subjects with a measurable lesion or bone lesions
排除标准
- •Previous radiotherapy within 6 weeks
- •Significant cardiac events, arrhythmias or other cardiac conditions
研究组 & 干预措施
2
Experimental
Vandetanib + Docetaxel
干预措施: Vandetanib (ZD6474) (Drug)
1
Placebo Comparator
Docetaxel + placebo vandetanib
干预措施: Docetaxel (Drug)
2
Experimental
Vandetanib + Docetaxel
干预措施: Docetaxel (Drug)
结局指标
主要结局
Number of Patients With a Disease Progression Event
时间窗: RECIST tumour assessments carried out at screening (within 3 weeks before the 1st dose) and then as per site clinical practice until objective progression. The only additional mandatory RECIST assessment is at the point of data cut-off
Number of patients with objective disease progression or death (by any cause in the absence of objective progression)
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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