A Phase 2 Randomized Open-Label Study of Neratinib Versus Lapatinib Plus Capecitabine For The Treatment Of ErbB-2 Positive Locally Advanced Or Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 233
- 试验地点
- 152
- 主要终点
- Progression Free Survival
研究概览
简要总结
This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.
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
- None
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 IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer
- •Prior use of Herceptin (trastuzumab), and a taxane
- •Adequate cardiac and renal function
排除标准
- •More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda (capecitabine) and / or Tykerb (lapatinib) [Tyverb]
- •Bone as the only site of disease
- •Active central nervous system metastases (subjects should be stable and off anticonvulsants and steroids)
- •Significant gastrointestinal disorder with diarrhea as major symptom
研究组 & 干预措施
Neratinib
干预措施: Neratinib (Drug)
Lapatinib plus Capecitabine
干预措施: Lapatinib (Drug)
Lapatinib plus Capecitabine
干预措施: Capecitabine (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: From randomization date to progression or death, assessed up to 69 months
Progression Free Survival, Measured in Months, for Subjects Randomized. Investigator assessment. The time interval from the date of randomization until the earliest date of progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or death due to any cause. For subjects without death or progression, censorship was at the last valid tumor assessment.
次要结局
- Overall Survival (OS)(From randomization date to death, assessed up to 69 months)
- Clinical Benefit Rate(From randomization date to progression or last tumor assessment, assessed up to 69 months)
- Objective Response Rate (ORR).(From randomization date to progression or last tumor assessment, assessed up to 69 months)
- Duration of Response(From start date of response to first PD, assessed up to 69 months after the first subject was randomized.)
- Time to CNS Metastases(From randomization date to first CNS symptom or lesions)
- Frequency of CNS Metastases (Frequency)(From randomization date to first CNS symptom or lesions)