NCT00189670已完成2 期
A Phase II Randomized Trial of 6 TEC Every 3 Weeks, Versus 4 EC Followed by 4 Taxotere Every 2 Weeks, Versus 4 Taxotere Followed by 4 EC Every 2 Weeks in Node Positive Breast Cancer
Association Européenne de Recherche en Oncologie0 个研究点开始时间: 2005年9月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
To screen a dose-dense arm to be used in a future large scale phase III trial. Primary endpoint is safety; secondary endpoints are disease free survival and overall survival. A total of 100 patients were included.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient with histologically proven breast cancer
- •Surgical resection performed with clear margins (R0 resection)
- •At least 1 histologically proven involved axillary node
- •ER + or ER-
- •Interval between surgery (2nd surgical procedure in case of multiple procedures) and randomization inferior to 60 days
- •Aged over 18 years, and more than 10-year life expectancy
- •ECOG performance status 0-1
- •Signed informed consent form prior to randomization
排除标准
- •Bilateral breast cancer
- •Inflammatory breast cancer
- •Personal history of breast cancer
- •Immunohistochemical only node involvement
- •Intraductal breast cancer
- •Distant metastases
- •Contraindication to any drug contained in the chemotherapy regimens
- •Any serious active disease or co-morbid medical condition including recent history of severe sepsis and digestive inflammatory disease
- •Poor renal function (creatinin level > 120 micromol/L), poor hepatic function (total bilirubin level > 1 UNL), transaminases > 2.5 UNL)
- •Poor bone marrow reserve as defined by neutrophils < 1.5 G/L or platelets < 100 G/L; Hemoglobin < 10 G/dL
- •Poor contractile cardiac function (LVEF < 50%)
- •Coronary disease
- •Any history of cancer during the last 5 years, with the exception of basal cell carcinomas or stage 0 (in situ) cervical carcinoma
- •Pregnancy or breast feeding
- •Absence of contraception in non menopausal women
- •Adult patient unable to give informed consent because of intellectual impairment
- •Concomitant participation to another trial
研究者
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