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临床试验/EUCTR2018-003275-35-NL
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

发起方
BOOG Study Center

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