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临床试验/EUCTR2019-003518-15-PL
EUCTR2019-003518-15-PL进行中(未招募)1 期

A Follow-Up Study of Long-Term Efficacy of Patients with HER2-Positive Early Breast Cancer Who Had Been Enrolled in Study CT-P6 4.2

Celltrion, Inc.0 个研究点目标入组 350 人开始时间: 2019年12月3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
350

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

  • Patients will be included if they meet all of the following inclusion criteria:
  • 1. Patient completed the last CT-P6 3.2 follow-up visit around October 2018 (regardless of her study treatement completion status).
  • 2. Patient is able to understand and to comply with protocol requirements, and instructions.
  • 3. Patient voluntarily agrees to participate in this study and has given a written informed consent prior to providing any information.
  • 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 350
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range 0

排除标准

  • Patients who meet the following exclusion citerion will be excluded from the study:
  • 1. Patient died during her participation in study CT-P6 3.2.

研究者

发起方
Celltrion, Inc.

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