NCT01423695已完成2 期
Weekly Application of Trastuzumab and Paclitaxel in the Treatment of HER2-overexpressing Metastatic Breast Cancer
WiSP Wissenschaftlicher Service Pharma GmbH1 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2001年2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
- 121
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The 3 weekly combination of trastuzumab and paclitaxel has been approved for the treatment of advanced breast cancer based on a large pivotal study. However, mono and combination chemotherapy trials suggest that weekly paclitaxel has a better therapeutic index, especially in the palliative setting. The present trial examines the efficacy and safety of weekly paclitaxel over a limited duration combined with continued trastuzumab in HER2+ patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed metastatic breast cancer overexpressing HER2
- •pretreatment with anthracycline in either the adjuvant or palliative setting.
- •HER2 positivity was defined as 2+ or 3+ overexpression using the DAKO HercepTest, confirmed by fluorescence in-situ hybridization (FISH) if 2+.
- •informed consent
排除标准
- •more than 1 chemotherapy for advanced disease
- •taxane or trastuzumab pretreatment
- •brain metastases
- •Eastern Cooperative Oncology Group (ECOG) performance status >1
- •pregnancy or lactation, childbearing potential without reliable contraception
- •clinically significant cardiac disease,
- •neutrophils <1500/µl, platelets <75,000/µl
- •total bilirubin and creatinine >1.5 × the upper limit of normal
研究组 & 干预措施
paclitaxel/trastuzumab
Experimental
Single experimental arm in a phase II trial
干预措施: paclitaxel plus trastuzumab (Drug)
结局指标
主要结局
Progression-free survival
时间窗: Patient follow-up on average for 15 months and up to a maximum of 51 months
次要结局
未报告次要终点
研究者
研究点 (1)
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