EUCTR2013-001863-21-NL进行中（未招募）不适用
Optimizing neoadjuvant systemic treatment in HER2 positive breast cancer - the TRAIN-2 study - TRAIN-2
BOOG Study Center0 个研究点开始时间: 2013年5月17日最近更新:
适应症
相关药物
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
- All
入选标准
- •1.Histologically confirmed infiltrating breast cancer.
- •2.Stage II or stage III disease. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan.
- •3.Overexpression and/or amplification of HER2 in an invasive component of the core biopsy, according to one of the following definitions:
- •>10% of invasive tumor cells showing strong complete circumferential membrane staining (score 3+)
- •HER2 gene amplification defined as =6 HER2 gene copies per nucleus by in situ hybridization.
- •4.Age =18
- •5.Eastern Cooperative Oncology Group performance status =1
- •6.LVEF =50% measured by echocardiography or MUGA
- •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 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 144
排除标准
- •1.Previous radiation therapy or chemotherapy
- •2.Pregnancy, breast feeding
- •3.Evidence of distant metastases.
- •4.Evidence of bilateral infiltrating breast cancer
- •5.Concurrent anti-cancer treatment or another investigational drug.
研究者
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