NCT03919253Unknown2 期
Pyrotinib in Combination With Nab-paclitaxel in Patients With HER2-positive Advanced Breast Cancer: an Exploratory Study
Hebei Medical University Fourth Hospital0 个研究点目标入组 80 人开始时间: 2019年4月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 主要终点
- Progress-free survival(PFS)
研究概览
简要总结
This clinical trial aim to evaluate the efficacy and safety of Pyrotinib in combination with nab-paclitaxel in patients with HER2-positive advanced 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
- •Age: 18-70 years old，female;
- •Pathologically confirmed HER2-positive invasive breast cancer by local laboratory with the following requirements: HER2 overexpressed or amplified (immunohistochemistry of 3+ or HER2 gene amplification by in situ hybridization)
- •Imaging examination confirmed recurrent/metastatic breast cancer；
- •Patients must have previous treatment with trastuzumab more than 9 weeks;
- •Untreated for metastatic/metastatic disease (except for endocrinotherapy);
- •Patients with at least one measurable lesions by RECIST version 1.1；
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2；
- •Life expectancy greater than or equal to 3 months;
- •Participants must have normal organ and marrow function as described below： Absolute neutrophil count≥1.5×109/L; Platelets≥90×109/L; Hemoglobin ≥90g/L； Total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN)； ALT and AST≤2*ULN, but ≤5*ULN with liver metastases; BUN and Cr≤1.5×ULN or creatinine clearance ≥50ml/min Left ventricular ejection fraction (LVEF) ≥ 50%
- •Doctors believe that treatment can bring benefits to patients；
- •Participants were willing to join in this study, and written informed consent.
排除标准
- •A variety of factors influencing oral drugs (after resection of the gastrointestinal, unable to swallow, Chronic diarrhea, intestinal obstruction);
- •Patients with other malignant tumors within 5 years (except for skin basal cell carcinoma and cervical carcinoma in situ);
- •History of psychiatric drugs abuse or patients with mental disorders;
- •Pregnant or lactating women;
- •Less than 4 weeks from the last clinical trial
- •The researchers think inappropriate.
研究组 & 干预措施
pyrotinib maleate tablets+nab-paclitaxel
Experimental
pyrotinib maleate tablets: 400mg orally once daily continunously; nab-paclitaxel: 125mg/m2 iv d1、8 of each 21 day cycle, 6cycles.
干预措施: pyrotinib maleate tablets+nab-paclitaxel (Combination Product)
结局指标
主要结局
Progress-free survival(PFS)
时间窗: three years
Baseline to measured date of progress or death from any cause
次要结局
- Disease control rate(DCR)(three years)
- Safety (number of Participants with adverse events)(three years)
- Clinical Benefit Rate (CBR)(three years)
- Overall survival (OS)(up to death)
- Objective response rate (ORR)(three years)
研究者
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