EUCTR2018-003275-35-NL进行中(未招募)1 期
Image-guided de-escalation of neoadjuvant chemotherapy in HER2-positive breast cancer: the TRAIN-3 study - TRAIN-3
BOOG Study Center0 个研究点目标入组 462 人开始时间: 2019年1月8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
- 462
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
入选标准
- •1. Histologically confirmed infiltrating breast cancer.
- •2. Stage II or III disease.
- •3. Overexpression and/or amplification of HER2 in an invasive component of the core biopsy.
- •4. Age <:18
- •5. ECOG Group performance status
- •6. LVEF >50% measured by echocardiography, MRI or MUGA
- •7. Known HR-status ( in percentages)
- •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 462
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 462
排除标准
- •1. Previous chemotherapy
- •2. Pregnancy or breastfeeding
- •3. Evidence of distant metastases
- •4. Evidence of bilateraal infiltrating breast cancer
- •5. Concurrent anti-cancer treatment or another investigational drug
研究者
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