RPCEC00000220尚未招募2 期
Specific active immunotherapy with the vaccine NGcGM3/VSSP in patients with metastatic hormone-receptor positive and HER2 negative breast cancer
Center of Molecular Immunology (CIM)0 个研究点目标入组 286 人开始时间: 2016年11月28日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 286
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
- Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 one（—）
- 性别
- Female
入选标准
- •1. Female patients with hormone-receptor positive and HER2-negative metastatic breast cancer, not previously treated for the metastatic disease.
- •2. Patients older than 18 years.
- •3. Patients who consent to participate in the study by signing the informed consent model.
- •4. Patients with ECOG scale of Performance Status = 2.
- •5. Patients who are not pregnant or breastfeeding.
- •6. Patients with paraffin-embedded samples for evaluation of the expression of NGcGM3.
- •7. Patients with normal functioning of organs and bone marrow defined by laboratory parameters.
排除标准
- •1. Patients who have been treated with NGcGm3/VSSP within 6 months prior to inclusion.
- •2. Patients who have been included in another clinical trial within 6 months prior to inclusion.
- •3. Patients with inflammatory carcinoma of the breast.
- •4. Patients with brain metastases.
- •5. Patients with acute or chronic infectious diseases.
- •6. Patients with decompensated chronic diseases.
研究者
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