Neratinib in Patients With HER2+ Breast Cancer: a Multi-centric, Multi-national, Prospective, Longitudinal, Non-interventional Study in Germany, Austria and Switzerland
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 10
- 主要终点
- Patient Compliance
研究概览
简要总结
So far, there is no data available on treatment of patients with early-stage hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2)-overexpressed/amplified breast cancer, who completed adjuvant trastuzumab-based therapy less than one year ago, in the clinical routine setting.
ELEANOR - designed as a prospective, longitudinal, non-interventional study (NIS) - will investigate real-world use of neratinib and its treatment management in patients with HR-positive, HER2-overexpressing/amplified breast cancer stage I-III having completed adjuvant trastuzumab-based therapy less than one year ago. Data from this study will contribute to a deeper understanding and characterization of the everyday use of neratinib in a broader patient population in the German and Austrian routine setting.
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
- •Written informed consent of the patient with regard to the pseudonymized documentation;
- •Legally capable female patient ≥ 18 years of age (no upper limit);
- •Decision was taken to treat the patient with neratinib in accordance with the current SmPC and by prescription; this decision was taken prior to and independent from the inclusion into the study;
- •Treatment with neratinib is planned to be started;
- •Hormone receptor (HR) positive, Human epidermal growth factor receptor 2 (HER2) overexpressing/amplified breast cancer stage I-III;
- •Completion of prior trastuzumab-based therapy less than 1 year ago;
- •No signs of relapse before initiation of neratinib treatment.
排除标准
- •Presence of any contraindication with regard to the neratinib treatment as specified in the corresponding Summary of Product Characteristics (SmPC);
- •Current or upcoming participation in an interventional clinical trial;
- •Prisoners or persons who are compulsorily detained (involuntarily incarcerated)
结局指标
主要结局
Patient Compliance
时间窗: 12 months of treatment
Rate of patients being compliant to therapy with neratinib. A patient is defined as being compliant, if she has taken the prescribed neratinib dose for at least 75% of the treatment days.
次要结局
- Patient profile at baseline(Baseline)
- Disease profiles at baseline(Baseline)
- Pretreatment characteristics at baseline(Baseline)
- Reason for neratinib treatment(Baseline)
- Neratinib treatment characteristics(12 months of treatment)
- Relapse of disease(through study completion; maximum follow-up 55 months)
- Patient reported outcome - EQ-5D-5L(12 months of treatment)
- Patients' treatment satisfaction: 5 point scale(12 months of treatment)
- Safety and tolerability of treatment with neratinib(12 months of treatment + 30 days of safety follow-up)
- Patient reported outcome - STIDAT(12 months of treatment)
- Physicians' treatment satisfaction: 5 point scale(12 months of treatment)