NCT00193024终止2 期
A Phase II Trial of Epirubicin/Docetaxel in the First-Line Treatment of Patients With Metastatic Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 90
- 主要终点
- Clinical response rate of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer
研究概览
简要总结
The epirubicin/docetaxel combination is one of the most active and best tolerated taxane/anthracycline combinations. In this phase II trial, we will further evaluate the feasibility, safety and effectiveness of the docetaxel/epirubicin combination, when administered as first-line treatment for metastatic breast cancer.
详细描述
Upon determination of eligibility, all patients will receive:
Docetaxel + Epirubicin
Both drugs will be repeated at 21-day intervals
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
- •To be included in this study, you must meet the following criteria:
- •Metastatic breast cancer confirmed by biopsy.
- •Received no previous chemotherapy for metastatic breast cancer.
- •Prior hormonal therapy is acceptable.
- •Measurable or evaluable disease.
- •Able to perform activities of daily living without considerable assistance
- •Adequate bone marrow, liver and kidney function
- •Must be able to understand the nature of this study and give written informed consent.
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Age < 18 years.
- •Cardiac ejection fraction < 45%.
- •Women who are pregnant or lactating.
- •Patients with meningeal metastases are ineligible.
- •Moderate peripheral neuropathy
- •History of hypersensitivity reaction to Taxotere
- •Males with metastatic breast cancer
- •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
Clinical response rate of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer
次要结局
- Safety of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer
研究者
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