NCT00401427已完成2 期
A Single-centre Phase 2 Study of Vinorelbine Plus 3-weekly Trastuzumab in Metastatic Breast Cancer Overexpressing Her-2
National Cancer Institute, Naples0 个研究点目标入组 50 人开始时间: 2002年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- response rate
研究概览
简要总结
The combination of vinorelbine with weekly trastuzumab has produced high response rate in HER2 overexpressing metastatic breast cancer (MBC). The present phase 2 study was planned to test activity of the same combination, with trastuzumab given every 3 weeks, rather than weekly.
详细描述
The schedule of treatment includes vinorelbine (30 mg/m2 on days 1 & 8 every 21 days) and trastuzumab (8 mg/kg on day 1 and then 6 mg/kg every 21 days). Vinorelbine is planned for maximum 9 cycles, while trastuzumab can be continued until progression. This study is a single-stage phase 2 design, and patients eligible for response evaluation are required.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed breast cancer
- •No prior or not more than one prior chemotherapy for metastatic disease
- •Overexpression of HER-2 (3+ on immunohistochemical exam) or amplified genetic expression of c-erbB2/neu (positive by Fish method)
- •Performance status 0-2 (ECOG)
排除标准
- •Absence of measurable disease
- •Life expectancy < 3 months
- •Concomitant malignancy or malignancy within previous 5 years (except basal cell or spinocellular skin cancer and in situ cervical cancer if they have been adequately treated
- •Previous treatment with trastuzumab or vinorelbine
- •Neutrophils < 1500/mm3 or platelets < 100000/mm3 or haemoglobin < 8 g/dl
- •Creatinine > 1.5 x the value of the upper normal limit
- •GOT and/or GPT > 2.5 x the value of the upper normal limit and/or bilirubin > 1.5 x the value of the upper normal limit in the absence of liver metastases
- •GOT and/or GPT > 5 x the value of the upper normal limit and/or bilirubin > 3 x the value of the upper normal limit in the presence of liver metastases
- •Left ventricular ejection fraction < 50% (measured by ultrasound or MUGA angiography)
- •Concomitant conditions that contraindicate the use of the drugs in the protocol
- •Male gender
- •Pregnancy or lactation·
- •Incapacity or refusal to provide informed consent
- •Inability to comply with followup
结局指标
主要结局
response rate
toxicity
次要结局
- time to progression
- overall survival
研究者
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