NCT05491057尚未招募不适用
A Multicenter, Open-label, Single-arm, Non-interventional Study to Investigate the Treatment Patterns of Nerlynx® (Neratinib) in HER2-positive Early-stage Breast Cancer in China
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Duration of Treatment
研究概览
简要总结
This is a multicenter, open-label, single-arm, non-interventional study to investigate the treatment patterns of Neratinib in HER2-positive early-stage breast cancer in China
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent approved by the reviewing Ethics Committee (EC).
- •Adult patients (≥18 years of age, no upper limit).
- •Eligible to receive neratinib for extended adjuvant treatment as per prescribing information in China, diagnosed with HER2 overexpressing/amplified early-stage breast cancer regardless of hormone receptor (HR) status and clinical/radiological assessed to be negative for recurrences or metastatic disease.
排除标准
- •Presence of any contraindication with regard to the neratinib treatment.
- •Current or upcoming participation in an interventional clinical trial. (Investigational treatment within four weeks of enrolment).
研究组 & 干预措施
Neratinib extended ajuvant treatmeng for 1 year
干预措施: Neratinib (Drug)
结局指标
主要结局
Duration of Treatment
时间窗: 12 months of treatment
Median duration of extended adjuvant treatment with neratinib
Treatment holds and permanent discontinuations time
时间窗: 12 months of treatment
Median treatment holds and permanent discontinuations time
次要结局
- Patient characteristics(Baseline)
- Severity of AESI(12 months of treatment)
- action taken for AESI(12 months of treatment)
- Patient demographics(Baseline)
- Time to treatment(Baseline)
- Prior adjuvant treatments(Baseline)
- Dose adjustments(12 months of treatment)
- Dose intensity(12 months of treatment)
- Incidence of AESI(12 months of treatment)
- Concomitant medication(12 months of treatment)
- Type of AESI(12 months of treatment)
研究者
研究点 (1)
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