NCT04126525进行中（未招募）2 期
NeoAdjuvant Trastuzumab/ Pyrotinib Plus Weekly Paclitaxel/Cisplatin in HER2-positive Locally Advanced Breast Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- pCR
研究概览
简要总结
This is a prospective, open label study to evaluate the efficacy and safety of neoadjuvant pyrotinib in early breast cancer patients.
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
- •Female, Aged ≥18 and ≤70 years
- •Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ⅡA-Ⅲ)
- •Subjects with at least one evaluable lesion
- •Adequate organ function
排除标准
- •Metastatic disease (Stage IV)
- •Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption
- •Treated or treating with T-DM1, lapatinib and neratinib before study entry
- •History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation
- •Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial
- •Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test. Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period
- •Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study
研究组 & 干预措施
neoadjuvant pyrotinib
Experimental
pyrotinib 400mg qd trastuzumab 4mg/kg loading dose, then 2mg/kg qw palitaxel 80mg/m^2, d1, 8, 15, 22 cisplatin 25mg/m^2, d1, 8, 15 every 28 days
干预措施: Pyrotinib (Drug)
结局指标
主要结局
pCR
时间窗: 1-2 weeks after surgery
pathological complete response
次要结局
未报告次要终点
研究者
Wenjin Yin
Deputy Chief of Breast Surgery Department
RenJi Hospital
研究点 (1)
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