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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 612
- 试验地点
- 11
- 主要终点
- Significant LVEF decrease, defined as an absolute decline of at least 10% points from
研究概览
简要总结
This is an observational cohort study.
[Survival Only Cohort]: The group consists of subjects who participate in this trial among subjects who received the SB3 or Herceptin® in the SB3-G31-BC trial and were not sequentially enrolled into this SB3-G31-BC-E trial as a Cardiac Safety and Survival Cohort. Subjects who received SB3 or Herceptin® in accordance with the clinical trial SB3-G31-BC and were not sequentially enrolled to SB3-G31-BC-E trial as a Cardiac Safety and Survival Cohort will be asked to consent to participate in this study as a Survival Only Cohort. 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 informed consent from (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 institutional review board (IRB)/independent ethics committee (IEC) and in accordance with national regulations. Data will be collected from medical records for up to 5 years from their last investigational product (IP; SB3 or Herceptin®) administration or death, unless they are lost for the follow-up or withdraw the informed consent. Data for the study will be collected prospectively from the date of the study informed consent signed and data before informed consent will be obtained from medical records retrospectively. If prospective data collection is not possible, data could be collected retrospectively from medical records.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •[Survival Only Cohort] Subjects must meet all of the following criteria to be eligible for the study:
- •Subjects who received SB3 or Herceptin® according to the clinical trial SB3-G31-BC.
- •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.
排除标准
- •There are no exclusion criteria for the Survival Only Cohort.
结局指标
主要结局
Significant LVEF decrease, defined as an absolute decline of at least 10% points from
时间窗: Entire Duration
The incidence of symptomatic CHF and asymptomatic significant LVEF decrease
时间窗: Entire Duration
CHF, defined as NYHA II, III, IV, confirmed by a cardiologist, accompanied by a
时间窗: Entire Duration
significant LVEF decrease
时间窗: Entire Duration
than 50%
时间窗: Entire Duration
baseline LVEF (LVEF at screening of the SB3-G31-BC trial) and resulting LVEF less
时间窗: Entire Duration
次要结局
- The incidence of cardiac death and other significant cardiac conditions(oCardiac death, defined as death definitely as a result of heart failure, myocardial infarction, or documented arrhythmia, or as probable cardiac death)