EUCTR2006-003620-11-NO进行中（未招募）不适用
A phase I/II study to assess the effect of soluble beta-1,3/1,6-glucan in combination with standard therapy in patients with breast cancer
Biotec Pharmacon ASA0 个研究点开始时间: 2006年8月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Women with locally advanced or metastatic breast cancer
- •2. Primary tumor or metastases are HER2-ICH3+ or FISH+
- •3. Have not received Herceptin or Vinorelbine treatment previously
- •4. Expected lifetime more than 12 weeks
- •5. Performance status 2 or less according to the WHO scale
- •6. Age 18 or more
- •7. Ability to comply with the protocol
- •8. Ability to consent to participation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Pregnant or breast-feeding women
- •2. Nervous system involvement
- •3. Left ventricular ejection fraction (LVEF) < 50% of normal range
- •4. Reduced bone marrow function defined by leukocyte counts < 3.0 x 109/l and 5. neutrophil counts < 1.5 x 109/l, or thrombocyte counts = 100 x 109/l
- •5. Reduced liver function defined by bilirubin > 3 upper normal limit and/or ASAT/ALAT > 3 x upper normal limit and/or alkaline phosphatase > 3 x upper normal limit
- •6. Reduced renal function defined by serum creatinine > 2 x upper normal limit
研究者
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