A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+Metastatic Breast Cancer Who Have Prior Received Anthracyclin, Taxane or Trastuzumab
试验速览
- 阶段
- 1 期
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Safety(adverse Events [AEs] and Serious Adverse Events [SAEs])
研究概览
简要总结
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of pyrotinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have prior received anthracyclin, taxane or trastuzumab. Patients will be stratified by weather have prior use of trastuzumab and randomized in a 1:1 ratio to one of the following treatment arms:
- Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m^2 twice daily)
- Arm B: lapatinib (1250 mg once daily) + capecitabine (1000 mg/m^2 twice daily) Patients will receive either arm of therapy until the occurrence of death, disease progression, unacceptable toxicity, or other specified withdrawal criterion.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 and ≤70 years.
- •ECOG performance status of 0 to
- •Life expectancy of more than 12 weeks.
- •At least one measurable lesion exists.(RECIST 1.1).
- •Histologically or cytologic confirmed HER2 positive advanced breast cancer which failed prior therapies.
- •Required laboratory values including following parameters:
- •ANC: ≥ 1.5 x 10^9/L;Platelet count: ≥ 100 x 10^9/L;Hemoglobin: ≥ 9.0 g/dL;Total bilirubin: ≤ 1.5 x upper limit of normal (ULN);ALT and AST: ≤ 1.5 x ULN;BUN and creatine clearance rate: ≥ 50 mL/min;LVEF: ≥ 50%;QTcF: < 470 ms for female and < 450 ms for male.
- •Signed informed consent
排除标准
- •Received previous therapy with lapatinib, neratinib, pyrotinib or any other HER2 directe tyrosine kinase inhibitor.
- •Received previous therapy with capecitabine within 3 months.
研究组 & 干预措施
pyrotinib plus capecitabine
pyrotinib(400 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID)
干预措施: pyrotinib (Drug)
pyrotinib plus capecitabine
pyrotinib(400 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID)
干预措施: capecitabine (Drug)
lapatinib plus capecitabine
lapatinib (1250 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID)
干预措施: Lapatinib (Drug)
lapatinib plus capecitabine
lapatinib (1250 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID)
干预措施: capecitabine (Drug)
结局指标
主要结局
Safety(adverse Events [AEs] and Serious Adverse Events [SAEs])
时间窗: : From consent through 28 days following treatment completion (estimated 18 months)
Objective Response Rate (ORR)
时间窗: Estimated 12 months
次要结局
- Progression Free Survival (PFS)(Estimated 18 months)
- Time to Progression (TTP)(Estimated 18 months)
- Duration of Response (DOR)(Estimated 18 months)