NCT00668616已完成3 期
Cyclophosphamid + Farmorubicin® With Subsequent Administration of Taxol® (q3w) Versus Intensified Administration of Farmorubicin® Followed by Taxol® (q2w) in the Adjuvant Treatment of Breast Cancer in Patients With 1-3 Afflicted Lymph Nodes (1-3 LK+)
North Eastern German Society of Gynaecological Oncology1 个研究点 分布在 1 个国家目标入组 1,034 人开始时间: 2000年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,034
- 试验地点
- 1
- 主要终点
- progression-free time
研究概览
简要总结
The purpose of this study is to determine whether a treatment with 4 cycles anthracycline + cyclophoshamide followed by administration of 4 cycles paclitaxel is more effective than therapy with 4 cy<cles of anthracycline adminbistration followed by 4 cycles of paclitaxel
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with histologically proven breast cancer (pT1/pT2/pT3, pN1, N0)
- •ECOG performance status 0-1
- •start of adjuvant therapy not later than 4 weeks after surgery
- •hematology: platelets at least 100xGpt/l, neutrophiles at least 2xGpt/l
- •normal liver function as defined by: bilirubine till 1.5 x normal value, SGOT/SGPT till 1.25 x normal value
- •normal kidney function as defined by: creatine till 1.5 x normal value
- •negative pregnancy test for patients before menopause and effective contraception
- •written informed consent
排除标准
- •prior radiation, chemotherapy, hormontherapy and immunotherapy
- •patients with more than 3 afflicted lymph nodes
- •afflicted lymph nodes on the cantralateal side and/or afflicted supraclavicular or intraclavicular lymph nodes
- •bilateral breast cancer or second carcinoma of the breast
- •inflammatory breast cancer and/or distant metastases
- •existing clinically relevant peripheral neuropathie
- •heart infection during the last 6 months or therapeutically not compensated heart failure or cardiac arrhythmias of at least LOWN II
- •patients with active infections and/or not controlled hypercalcemia
- •pregnant or breastfeeding women or women of child-bearing age who do not use effictive contrazeptiva
研究组 & 干预措施
1
Active Comparator
干预措施: Cyclophosphamide, Epirubicin, Paclitaxel (Drug)
2
Experimental
干预措施: Epirubicin, Paclitaxel, Filgrastim (Drug)
结局指标
主要结局
progression-free time
时间窗: every 3-6 months
次要结局
- toxicity
- overall survival(5 years)
研究者
研究点 (1)
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