NCT00193089已完成2 期
Phase II Trial of Weekly Docetaxel, Vinorelbine, and Herceptin in the First-Line Treatment of Patients With Metastatic Breast Cancer and Overexpression of Her-2
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- feasibility and toxicity of the combination of weekly docetaxel, vinorelbine, and trastuzumab in patients with metastatic breast cancer who overexpress Her-2.
研究概览
简要总结
In this phase II trial we attempt to improve upon the efficacy of the trastuzumab/vinorelbine combination by adding weekly docetaxel. When administered on a weekly schedule, docetaxel is well tolerated with minimal myelosuppression, so that it is likely that fully efficacious doses of all three drugs can be administered
详细描述
Upon determination of eligibility, all patients will be receive:
Trastuzumab + Vinorelbine + Docetaxel
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
- •To be included in this study, you must meet the following criteria:
- •Metastatic breast cancer confirmed by biopsy
- •Overexpression of the Her-2 oncogene
- •Age > 18 years
- •Measurable disease
- •Able to perform activities of daily living with minimal assistance
- •No previous chemotherapy for metastatic disease
- •One or more previous hormonal therapies for metastatic disease.
- •Adequate bone marrow, liver and kidney function
- •Patients with < grade 1 peripheral neuropathy are eligible.
- •Must give written informed consent prior to entering this study.
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Abnormal heart function
- •Previous treatment with trastuzumab
- •Brain metastases untreated
- •Pre-existing symptomatic peripheral neuropathy
- •Serious underlying medical conditions
- •Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
结局指标
主要结局
feasibility and toxicity of the combination of weekly docetaxel, vinorelbine, and trastuzumab in patients with metastatic breast cancer who overexpress Her-2.
时间窗: 18 Months
次要结局
未报告次要终点
研究者
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