EUCTR2018-004457-24-SE进行中（未招募）1 期
PREDIX II HER2. Improving pre-operative systemic therapy for human epidermal growth factor receptor 2 (HER2) amplified breast cancerPart of a platform of translational phase 2 trials based on molecular subtypes. - PREDIX II HER2
Karolinska University Hospital0 个研究点目标入组 190 人开始时间: 2019年1月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 190
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
- •-Confirmed PD-L1 expression =1% on tumour cells and/or TILs (prescreening phase)
- •-Able to provide written informed consent
- •-Female gender
- •-Patients with breast cancer confirmed by histology, characterized by immunohistochemistry for ER, PR, HER2 and proliferation marker.
- •-HER2 amplification, IHC 3+ and preferably confirmed by ISH
- •-Tumour and blood samples available.
- •-Age 18 years or older.
- •-Primary breast cancer >20 mm in diameter and/or verified lymph node metastases
- •-Performance status 0-1.
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •-Distant metastases without chance to cure.
- •-Other malignancies within the last five years.
- •-Patients in child-bearing age without adequate contraception.
- •-Pregnancy or lactation.
- •-History of autoimmune disease
研究者
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终止
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