A Randomized, Double-Blind, Placebo-Controlled Trial Of Neratinib (HKI-272) After Trastuzumab In Women With Early-Stage HER-2/Neu Overexpressed/Amplified Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,840
- 试验地点
- 485
- 主要终点
- Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2
研究概览
简要总结
The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.
- •Been treated for early breast cancer with standard of care duration of trastuzumab.
- •Could have been treated neoadjuvantly but have not reached pathologic complete response.
排除标准
- •Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.
- •History of heart disease.
- •Corrected QT (QTc) interval >0.45 seconds
- •History of gastrointestinal disease with diarrhea as the major symptom.
研究组 & 干预措施
Neratinib
240 mg orally daily for one year
干预措施: neratinib (Drug)
Placebo
orally daily for one year
干预措施: placebo (Other)
结局指标
主要结局
Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2
时间窗: From randomization until time of event up to 2 years
Invasive disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.
Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms
时间窗: From randomization until time of event up to 2 years
次要结局
- Overall Survival (OS)(Randomization until death due to any cause (up to 119 Months))
- Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm at Year 2(From randomization until time of event up to 2 years)
- Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms(From randomization until time of event up to 2 years)
- Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm at Year 2(From randomization until time of event up to 2 years)
- Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms(From randomization until time of event up to 2 years)
- Percentage of Participants With Time to Distant Recurrence (TTDR) Event in Neratinib Arm Compared to Placebo Arm at Year 2(From randomization until time of event up to 2 years)
- Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms(From randomization until time of event up to 2 years)
- Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm at Year 2(From randomization until time of event up to 2 years)
- Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2(From randomization until time of event up to 2 years)