NCT00189644Unknown3 期
6 FEC 100 Vs 4 FEC 100 Followed by 4 Taxol in N+ 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
- 3 期
- 发起方
研究概览
简要总结
The main objective of this randomized trial is to compare 6 FEC100 to 4 FEC100 + 4 Taxol in patients with resected node positive breast cancer. Main endpoint is disease free survival. Secondary endpoints are overall survival, time to local recurrence, time to distant metastases, and tolerance. A total of 840 patients have been included in the trial.
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
- •Histologically proven cancer of the breast,
- •Mastectomy or complete tumorectomy,
- •Histologically proven homolateral, axillary lymph node involvement (at least 1 N+)
- •Period between surgery (second operation in case of primarily incomplete resection) and the start of chemotherapy < 2 months,
- •Biological criteria (before the first FEC cycle):
- •Neutrophils >1.5 109 /L
- •Platelets >100 109/L
- •Hemoglobin >10 g/dl
- •Creatininemia <120 mmol/1
- •Bilirubinemia <1.5 Upper normal value
- •Female patients over 18 years old
- •Written and signed informed consent
- •Performance Status less than or equal to 2 (WHO scale, see Annex IV)
排除标准
- •Prior chemotherapy or radiotherapy, including neo-adjuvant treatment for cancer of the breast,
- •Bilateral breast cancer or history of contralateral breast cancer
- •Cardiac history: cardiac insufficiency (LVEF <50%) or coronary decompensation
- •Pregnancy and breast-feeding (effective contraception is mandatory in the case of women of child-bearing potential)
- •Inflammatory breast cancer
- •Distant metastasis or supraclavicular adenopathy
- •Benign pathology or history of malignant pathology accompanied by a life expectancy of less than two years
- •Contra-indication to Anthracyclines, Cyclophosphamide, 5FU or Taxol
- •Psychiatric pathology
- •Patient participating in another trial
研究者
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