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
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