NCT03412383Unknown2 期
A Phase II Study of Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
Peking Union Medical College1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2018年2月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
A Phase II Study of Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able to understand and willing to sign an Institutional Review Board（IRB） approved written informed consent document.
- •At least 18 years of age. Histologically or cytologically confirmed HER2-negative (0 or 1+ by immuno-histochemical (IHC) or non-amplified by FISH) breast cancer that is stage IV.
- •There is no standard therapy. At least one measurable disease by RECIST 1.1 is required. Karnofsky performance status (KPS)>70, life expectancy > 12 weeks
排除标准
- •Lack of adequate organ function as defined below within 2 weeks of registration:
- •Absolute neutrophil count (ANC)<1.5×109/L，platelet counts (PLT)<75×109/L or hemoglobin (Hb)<100g/L Total bilirubin (TBiL)>2×upper limit of normal (ULN); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)>2.5×ULN（or>5 x ULN for patients with liver metastases）; Alkaline phosphatase (ALP)>2.5×ULN; serum creatinine concentration (Scr)>140umol/L Pregnant and/or breastfeeding. History of significant cardiac disease, cardiac risk factors, or uncontrolled arrhythmias.
- •Having a history of uncontrolled paroxysmal diseases, including central nervous system diseases or mental disorders which may have an impact on the understanding and signature of informed consent Uncontrolled acute infection Currently receiving any other investigational agents or systemic cancer therapy.
- •Allergy to any investigational drug ; Any other condition that investigator considers inappropriate to participate in this trail
结局指标
主要结局
Progression-free survival (PFS)
时间窗: up to 36 months
From date of first use Pyrotinib until the date of first documented progression or date of death from any cause, whichever came first
次要结局
- Adverse events (AEs)(up to 36 months)
- Overall Response rates (ORR)(up to 36 months)
- Clinical Benefit rate (CBR)(up to 36 months)
- Time to Progression (TTP)(up to 36 months)
- Quality of Life(QoL)(up to 36 months)
- Overall survival (OS)(up to 52 months)
研究者
Fei Ma
Clinical Professor
Peking Union Medical College
研究点 (1)
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