EUCTR2015-005663-17-BG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
- 612
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
- •[Cardiac Safety and Survival Cohort]
- •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 trial according to the protocol.
- •2. Subjects must provide informed consent.
- •[Survival Only Cohort]
- •Inclusion criteria
- •Subjects must meet all of the following criteria to be eligible for the study:
- •1. Subjects who received SB3 or Herceptin® according to the clinical trial SB3-G31-BC.
- •2. Subjects who provide informed consent. If prospective data collection is not possible (e.g. when the subject is deceased or lost to follow-up), a waiver of informed consent/authorization will be requested for the retrospective data collection from medical records, where applicable and in accordance with national regulations and local ethics. If ICF waiver for the deceased subject is not allowed, their next-of-kin (if applicable) will be informed accordingly, and will be asked to give their consent where applicable and approved by IRB/IEC and in accordance with national regulations.
- •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 555
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 57
排除标准
- •[Cardiac Safety and Survival Cohort]:
- •Subjects unwilling to follow the study requirements are not eligible for the study.
- •[Survival Only Cohort]:
- •There is no exclusion criteria for the Survival Only Cohort.
研究者
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尚未招募
3 期
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