NCT00356681终止2 期
A Randomized Phase 2 Trial of Double-Blind, Placebo Controlled AMG 706 in Combination With Paclitaxel, or Open-Label Bevacizumab in Combination With Paclitaxel, as First Line Therapy in Women With HER2 Negative Locally Recurrent or Metastatic Breast Cancer
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
- Amgen
- 入组人数
- 282
- 主要终点
- Objective response rate, measured radiologically and assessed by an independent review committee.
研究概览
简要总结
To determine if treatment with paclitaxel plus AMG 706 is superior to paclitaxel plus AMG 706 placebo in subjects with HER2 negative locally recurrent or metastatic breast cancer. Also to estimate differences between treatment with paclitaxel plus AMG 706 and paclitaxel plus bevacizumab.
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
- •Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease.
- •Measurable disease by RECIST guidelines.
- •Tumor (primary or metastatic) must be HER2 negative.
- •Adequate organ and hematologic function. Exclusion:
- •Taxane treatment within 12 months prior to registration.
- •Prior chemotherapy for locally recurrent or metastatic breast cancer (prior endocrine therapy is permitted).
- •Prior radiation therapy, radiofrequency ablation, percutaneous cryotherapy or hepatic chemoembolization on all sites of measurable disease.
- •Current or prior history of central nervous system metastases.
- •Peripheral neuropathy ≥ grade 2 (CTCAE v3.0) at registration.
- •History of arterial or venous thrombosis within 1 year prior to registration.
- •History of bleeding diathesis or bleeding within 14 days of registration.
- •Uncontrolled hypertension (systolic >145 mmHg; diastolic >85 mmHg).
- •Clinically significant cardiac disease within 12 months of registration.
- •Known HIV positive, hepatitis C positive or hepatitis B surface antigen positive.
- •Prior treatment with VEGFr targeted therapies.
排除标准
- 未提供
研究组 & 干预措施
Arm A Placebo
Placebo Comparator
Blinded AMG 706 placebo plus paclitaxel
干预措施: AMG 706 placebo (Drug)
Arm A Placebo
Placebo Comparator
Blinded AMG 706 placebo plus paclitaxel
干预措施: Paclitaxel (Drug)
Arm B Experimental
Experimental
Blinded AMG 706 plus paclitaxel
干预措施: AMG 706 (Drug)
Arm B Experimental
Experimental
Blinded AMG 706 plus paclitaxel
干预措施: Paclitaxel (Drug)
Arm C Comparator
Active Comparator
Open-label bevacizumab plus paclitaxel
干预措施: Bevacizumab (Drug)
Arm C Comparator
Active Comparator
Open-label bevacizumab plus paclitaxel
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Objective response rate, measured radiologically and assessed by an independent review committee.
时间窗: Last patient enrolled + 16 weeks of treatment
次要结局
- Progression free survival, duration of response, clinical benefit rate (percentage of subjects with complete response, partial response or stable disease lasting >24 weeks), overall survival and incidence of adverse events.(>24 weeks)
研究者
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