A Phase II, Double-Blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of AZD2171 in Combination With Fulvestrant vs Fulvestrant Alone in Hormone Sensitive (ER+ve or PgR+ve) Post Menopausal Metastatic Breast Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this study is to determine whether AZD2171 can effectively improve time to tumour progression when added to fulvestrant in patients with advanced hormone sensitive breast cancer who progressed on prior hormonal therapy.
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 130 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Females with histological/cytological confirmation of hormone sensitive breast cancer with evidence of metastatic disease
- •One or more evaluable lesions
排除标准
- •Prior hormonal therapy with fulvestrant
- •More than one course of prior systemic cytotoxic chemotherapy for metastatic breast cancer
- •Prior biologic therapy for ABC including Anti-VEGF agents
- •Radiation therapy within 4 weeks prior to provision of consent
研究组 & 干预措施
2
Fulvestrant Monotherapy
干预措施: Fulvestrant (Drug)
3
AZD2171 + Fulvestrant
干预措施: AZD2171 (Drug)
3
AZD2171 + Fulvestrant
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.
Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.
次要结局
- Clinical Benefit Rate(Every 8 weeks until progression or discontinuation)
- Duration of Clinical Benefit(Every 8 weeks until progression or discontinuation)
- Objective Response Rate(RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.)
- Duration of Response(Every 8 weeks until progression or discontinuation)