NCT00533364已完成1 期
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 ASA4 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2007年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- Asess the safety of SBG in combination with standard antibody and chemotherapy treatment
研究概览
简要总结
This study is set up to determine whether soluble beta-glucan (SBG) has
- unfavourable side effects
- beneficial treatment effects when given in combination with standard antibody and chemotherapy to patients with breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Women with histologically/cytologically confirmed locally advanced or metastatic breast cancer
- •Primary tumor or metastases are HER2-ICH3+ or FISH+
- •Measurable or non-measurable disease
- •The patients must not have received treatment with the combination trastuzumab and vinorelbine previously
- •Expected lifetime of more than 12 weeks
- •Age ≥ 18 years
- •Performance status ≤ 2 according to World Health Organization (WHO) scale
- •The patient must be able to comply with the protocol
- •Verbal and written informed consent
排除标准
- •Women who are pregnant or breast-feeding. A negative pregnancy test must be provided during the screening period for fertile women. Fertile women must use effective contraceptive methods
- •Clinical symptoms indicating central nervous system involvement
- •Other current or former malignant disease, with the exception of adequately treated and cured carcinoma in situ cervicis uteri and basocellular skin carcinomas
- •Left ventricular ejection fraction (LVEF) < 50% of normal range
- •Reduced bone marrow function defined by leukocyte counts < 3.0 x 109/l and neutrophil counts < 1.5 x 109/l, or thrombocyte counts ≤ 100 x 109/l
- •Reduced liver function defined by bilirubin > 3 x upper normal limit and/or ASAT/ALAT > 3 x upper normal limit and/or alkaline phosphatase > 3 x upper normal limit.
- •Reduced renal function defined by serum creatinine > 2 x upper normal limit
结局指标
主要结局
Asess the safety of SBG in combination with standard antibody and chemotherapy treatment
时间窗: 21 weeks
次要结局
未报告次要终点
研究者
研究点 (4)
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