NCT02771795终止不适用
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
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 538
- 试验地点
- 40
- 主要终点
- Number of Subjects With Asymptomatic Significant LVEF Decrease
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects who received the study treatment of SB3-G31-BC.
- •Subjects who provide informed consent.
排除标准
- •Subjects unwilling to follow the study requirements are not eligible for the study.
研究组 & 干预措施
Herceptin (trastuzumab)
Intravenous administration
干预措施: Herceptin (trastuzumab) (Drug)
SB3 (proposed trastuzumab biosimilar)
Intravenous administration
干预措施: SB3 (proposed trastuzumab biosimilar) (Drug)
结局指标
主要结局
Number of Subjects With Asymptomatic Significant LVEF Decrease
时间窗: approximately 56 months (median follow-up duration)
Asymptomatic significant LVEF decrease is defined as LVEF decline ≥ 10% points from baseline and resulting LVEF \< 50%
次要结局
未报告次要终点
研究者
研究点 (40)
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