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临床试验/EUCTR2014-004432-18-NL
EUCTR2014-004432-18-NL进行中(未招募)1 期

Activity of trastuzumab based chemotherapy in metastatic breast patients with HER2-negative primary tumor but HER2 positive circulating tumor cells (CareMore-Trastuzumab)

Erasmus MC Cancer Institute0 个研究点目标入组 37 人开始时间: 2014年11月27日最近更新:
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
37

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

  • Female patient with metastatic breast cancer with HER2-negative primary tumor
  • Age = 18 years old
  • WHO performance status =2
  • Considered fit enough to receive trastuzumab/docetaxel by the treating physician
  • Able to understand and give written informed consent
  • Secondary inclusion criteria
  • Female patient with metastatic breast cancer with HER2-negative primary tumors with the presence of at least one HER2-positive CTC
  • Adequate left-ventricular ejection fraction (LVEF) of at least 45%
  • 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 30
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 7

排除标准

  • Previous chemotherapy for metastatic disease.
  • Adjuvant chemotherapy within 6 months prior to treatment start.
  • Hormonal antitumor treatment within one week prior to treatment start.
  • Symptomatic CNS metastases

研究者

发起方
Erasmus MC Cancer Institute

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