ACTRN12611000506998已完成3 期
High-risk patients with operable breast cancer treated with Epirubicin followed by Paclitaxel followed by Cyclophosphamide-Methotrexate-Fluorouracil (E-T-CMF) or Epirubicin followed by Cyclophosphamide-Methotrexate-Fluorouracil (E-CMF) as adjuvant chemotherapy to investigate the effect of the treatment on disease-free survival and overall survival.
Hellenic Cooperative Oncology Group0 个研究点目标入组 600 人开始时间: 2011年5月16日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •Histologically-confirmed epithelial cancer of the mammary gland. -Premenopausal patients with T1 to T2 classification with histologically-confirmed invasion of axillary lymph nodes (N1 classification) or T3 and N0 or N1 classification. -Postmenopausal patients with T1 to T2 classification and > 4 positive axillary nodes or T3 and N0 or N1 classification. - White Blood Cells (WBC) >4x10^9/litre, platelets >100 x10^9 /litre. -Serum creatinine, Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), gamma-glutamyltranspeptidase (gamma-GT), serum bilirubin < = 1.3 milligram/milliliter (mg/ml) or inside the normal range of the participating hospital. -Performance status (World Health Organization) 0 or 1. -Age >= 18 years. -Previous surgical treatment: Either radical surgery (i.e. total, radical or modified radical mastectomy), or, for a partial mastectomy, a histologically confirmed sane margin of 2 cm or more and the results of the axillary node dissection available. -Time from surgery 2 to 4 weeks -Informed consent of the patient according to the dispositions of the Helsinki convention and its Tokyo and Venice amendments and to individual institutional policy.
排除标准
- •- Previous antitumor chemotherapy or radiation
- •- History of myocardial infarction within the previous 12 months or heart failure (including cardiac insufficiency controlled by digitalis and diuretics) or arrhythmias requiring medication or uncontrolled arterial hypertension (Blood Pressure>= 200/110 millimetres of mercury (mmHg). In high risk patients a normal baseline left ventricular ejection fraction (LVEF) should be demonstrated by Multi Gated Acquisition Scan (MUGA) scan or echocardiogram (ECHO).
研究者
相似试验
已完成
不适用
Epirubicin/Paclitaxel/Cyclophosphamide-Methotrexate-Fluorouracil (E-T-CMF) as adjuvant chemotherapy in high-risk patients with operable breast cancerCancer - BreastBreast CancerACTRN12615000161527Hellenic Cooperative Oncology Group1,000
已完成
不适用
Investigation of the prognostic role of protein expression, mRNA levels, gene amplification and mutation of key cellular elements in patients with breast cancer treated with dose-dense sequential adjuvant chemotherapyCancer - BreastBreast CancerACTRN12616001043426Hellenic Cooperative Oncology Group1,060
已完成
不适用
Selection of Breast Cancer Patients with Low-risk Tumors using MR Imagingbreast cancerNL-OMON36966niversitair Medisch Centrum Utrecht60
已完成
不适用
Prevention of breast cancer in high risk women by monitoring microrna expression in nipple aspirate fluid.breast carcinoma100836241000629110006232breast cancerNL-OMON44762niversitair Medisch Centrum Utrecht720
已完成
不适用
High Dose Therapy in Poor-Risk Primary Breast CancerBreastCancerBreast cancerISRCTN52623943Amgen Limited (UK)