NCT00770354终止2 期
A Phase II, Randomised, Open-Label, Multicentre Study of AS1402 in Combination With Letrozole as First Line Treatment in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Antisoma Research2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2008年9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
- 终止
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- The primary efficacy endpoint is overall response rate (ORR)
研究概览
简要总结
The aim of this study is to compare the overall tumour response rate per RECIST in postmenopausal women with metastatic or locally advanced breast cancer receiving AS1402 in combination with letrozole compared to letrozole alone
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
- •Histologically or cytologically confirmed locally advanced or metastatic breast cancer not amenable to curative therapy
- •Measurable disease according to the RECIST criteria
- •Documented estrogen receptor-positive and/or progesterone receptor-positive tumour
- •Postmenopausal women
排除标准
- •Prior chemotherapy and/or endocrine therapy for advanced breast disease
- •Relapse within 12 months after treatment discontinuation of an aromatase inhibitor in the adjuvant setting
- •Unknown hormonal receptor status
- •Known HER2/neu-positivity
研究组 & 干预措施
1
Experimental
AS1402 plus letrozole
干预措施: AS1402 (Drug)
2
Active Comparator
Letrozole
干预措施: Letrozole (Drug)
结局指标
主要结局
The primary efficacy endpoint is overall response rate (ORR)
时间窗: Radiological evaluations are performed every 12 weeks up to progression
次要结局
- Progression-free survival (PFS)(Radiological evaluations are performed every 12 weeks up to progression)
- Time to progression (TTP)(Radiological evaluations are performed every 12 weeks up to progression)
- Duration of overall response and duration of stable disease(Radiological evaluations are performed every 12 weeks up to progression)
- Clinical benefit rate (CBR)(Radiological evaluations are performed every 12 weeks up to progression)
- Safety and tolerability of AS1402 when combined with letrozole(Radiological evaluations are performed every 12 weeks up to progression)
研究者
研究点 (2)
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