NCT00919880已完成2 期
A Phase II Randomized Clinical Trial of Neo-adjuvant Weekly Paclitaxel With or Without Carboplatin in Early Breast Cancer
Tao OUYANG1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2009年7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
- 148
- 试验地点
- 1
- 主要终点
- significant effect rate (the proportion of G4 and G5, graded by Miller & Payne Method); null effect rate (the proportion of G1 and G2)
研究概览
简要总结
The purpose of this study is to determine whether neo-adjuvant weekly paclitaxel with carboplatin is better than paclitaxel alone in efficiency and safety in early breast cancer, and to explore whether ultrasound and magnetic resonance imaging can predict the efficiency of neo-adjuvant chemotherapy.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients between 18 and 65 years old
- •pathological diagnosed invasive breast cancer; medium and high risk primary breast cancer according to St. Gallen 2007
- •able and willing to give consent to participate in the study
排除标准
- •pregnant or lactating females
- •previous treatment for breast cancer
- •other tumor history
- •instable complication (e.g., myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or uncontrolled infection
- •allergy history to similar drugs
- •concurrent disease or condition that would make the patient inappropriate for study participation
- •resist to participate in the study
研究组 & 干预措施
Experimental
Experimental
干预措施: carboplatin+ paclitaxel (Drug)
Experimental
Experimental
干预措施: paclitaxel (Drug)
Active Comparator
Active Comparator
干预措施: paclitaxel (Drug)
结局指标
主要结局
significant effect rate (the proportion of G4 and G5, graded by Miller & Payne Method); null effect rate (the proportion of G1 and G2)
时间窗: within the first 14 days (plus or minus 3 days) after surgery
次要结局
未报告次要终点
研究者
Tao OUYANG
Chairman of Breast Center
Peking University
研究点 (1)
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