Phase 2 Study of HKI-272 In Subjects With Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 33
- 主要终点
- 16-week Progression Free Survival
研究概览
简要总结
The purpose of this study is to learn whether neratinib is safe and effective in treating women with advanced human epidermal growth factor receptor 2 (HER2) positive breast cancer.
详细描述
Arm A: HER2 gene amplification and disease progression following at least 6 weeks of standard doses of Herceptin; Arm B: HER2 gene amplification and no prior Herceptin or HER2-targeted treatment.
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
- •Pathologic diagnosis of breast cancer and current stage IIIB, IIIC, or IV
- •Progression following at least 6 weeks of standard doses of Herceptin (Arm A only)
- •Over-expression of HER2
- •Tumor tissue available and adequate for analysis at screening
- •At least one measurable lesion
排除标准
- •Prior treatment with Herceptin (Arm B only)
- •More than 4 prior cytotoxic chemotherapy regimens
- •Subjects with bone or skin as the only site of measurable disease
- •Inadequate cardiac function
- •Major surgery, chemotherapy, radiotherapy, investigational agents or other cancer therapy within 1 week of treatment day 1
- •Active central nervous system metastases
- •Pregnant or breastfeeding women
- •Inability to swallow the HKI-272 capsules
研究组 & 干预措施
Neratinib 240 mg, with prior trastuzumab
Neratinib administered with 80 mg capsules and 40 mg coated tablets taken orally in prescribed dose of 240 mg daily, as long as tolerated and disease does not worsen.
干预措施: neratinib (Drug)
Neratinib 240 mg, no prior trastuzumab
Neratinib administered with 80 mg capsules and 40 mg coated tablets taken orally in prescribed dose of 240 mg daily, as long as tolerated and disease does not worsen.
干预措施: neratinib (Drug)
结局指标
主要结局
16-week Progression Free Survival
时间窗: From first dose to 16 weeks
16 week progression-free survival (PFS) rate of neratinib in women with human epidermal growth factor receptor 2 (HER2) positive breast cancer, either with prior trastuzumab or no prior trastuzumab therapy, evaluated by independent assessment of tumor scans collected at baseline and then every 8 weeks.
次要结局
- Objective Response Rate(From first dose date to progression or last tumor assessment, up to 46 months)
- Duration of Response(From start date of response to first PD/death, up to 46 months)
- Clinical Benefit Rate(From first dose date to progression or last tumor assessment, up to 46 months)