NCT04367090已完成1 期
An Open, Single-arm and Multi-center Pharmacokinetic Study of Pyrotinib and Docetaxel Plus Trastuzumab in Patients With HER2 Positive Recurrent or Metastasis Breast Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameter: AUC of pyrotinib and docetaxel
研究概览
简要总结
The primary objective of the study is to study the pharmacokinetics of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.
The secondary objective of the study is to evaluate the safety and efficacy (ORR) of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HER2 positive recurrent or metastasis breast cancer.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •Adequate organ function.
- •Signed, written inform consent obtained prior to any study procedure.
排除标准
- •Patients received more than 1 line of chemotherapy or immunotherapy in the phase of recurrence / metastasis.
- •History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting，except trastuzumab ,or Pertuzumab used in the neo-adjuvant or adjuvant setting.
- •Assessed by the investigator to be unable receive systemic chemotherapy.
- •History of other malignancy within the last 5 years，except for carcinoma in situ of cervix，basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent.
- •Pregnant or lactating women，or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.
研究组 & 干预措施
Pyrotinib and docetaxel plus trastuzumab
Experimental
干预措施: Docetaxel, trastuzumab (Drug)
Pyrotinib and docetaxel plus trastuzumab
Experimental
干预措施: Pyrotinib (Drug)
结局指标
主要结局
Pharmacokinetic parameter: AUC of pyrotinib and docetaxel
时间窗: Approximately 2 months
Area under the plasma concentration versus time curve (AUC) of pyrotinib and docetaxel
Pharmacokinetic parameter: Cmax of pyrotinib and docetaxel
时间窗: Approximately 2 months
Peak Plasma Concentration (Cmax) of pyrotinib
次要结局
- ORR(Approximately 17 months)
- AEs+SAEs(Approximately 17 months)
- λz(Approximately 6 months)
- The incidence of≥3 grade diarrhea with different treatment(Approximately 17 months)
研究者
研究点 (1)
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