EUCTR2015-005663-17-FR进行中(未招募)1 期
A Long-term Follow-up Study for Cardiac Safety in the Patients with HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 573
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
- •Subjects must meet all of the following criteria to be eligible for the study:
- •1.Subjects who have completed the study treatment of SB3-G31-BC according to the protocol.
- •2.Subjects must provide informed consent.
- •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 516
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 57
排除标准
- •Subjects unwilling to follow the study requirements are not eligible for the study.
研究者
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尚未招募
3 期
A Long-term Follow-up Study for Cardiac Safety in the Patients with HER2 positive Breast Cancer Who Have Completed the SB3-G31-BC study.CTRI/2020/02/023210Samsung Bioepis Co Ltd
