NCT02286362已完成不适用
An Observational Study of the Safety of Herceptin Given Subcutaneously in Patients With Early HER2-positive Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 510
- 试验地点
- 97
- 主要终点
- Safety (composite outcome measure): Incidence, nature, and severity according to NCI-CTCAE v. 4.0 of: adverse events (AEs), serious AEs, grade >/= 3 AEs, non-serious adverse drug reaction or causality unknown, AESI (congestive heart failure)
研究概览
简要总结
This non-interventional prospective study will assess the safety of Herceptin SC (subcutaneous administration) as used in routine clinical practice. Patients with HER2-positive early breast cancer, naive and non-naive of HER2+ treatment who are to be treated in the neoadjuvant and adjuvant setting and scheduled to initiate a treatment with Herceptin SC in routine clinical practice use are eligible to participate. The total study duration is anticipated to be 38 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Aged >/= 18 years
- •Patients with HER2-positive early breast cancer who according to national guidelines are eligible for neoadjuvant or adjuvant HER2+ treatment
- •Patients for whom the investigator has decided to start a treatment with Herceptin SC
- •Trastuzumab treatment naive or non-naive (previously intravenous treatment)
- •Informed consent
排除标准
- •Patients previously treated with Herceptin SC treatment
结局指标
主要结局
Safety (composite outcome measure): Incidence, nature, and severity according to NCI-CTCAE v. 4.0 of: adverse events (AEs), serious AEs, grade >/= 3 AEs, non-serious adverse drug reaction or causality unknown, AESI (congestive heart failure)
时间窗: approximately 13 months
次要结局
- Number of modalities regarding dose and injection site of Herceptin SC administration(Up to 12 months)
- Patient-reported outcome: Quality of Life using the EORTC QLQ-C30 questionnaire(Every 3 months, up to 12 months)
- Demographic data(Up to 12 months)
研究者
研究点 (97)
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