Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer: an Open-label, Multi-center Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- iDFS
研究概览
简要总结
This trial is a multicenter, open-label, phase II trial conducted at 23 centers in China. High-risk HER2 positive patients receive pyrotinib 400mg/day for one year or half year for extented adjuvant therapy.
详细描述
Patients must meet one of the following criteria: N stage ≥1; T stage ≥2; did not achieve pathological complete response (pCR) after neoadjuvant therapy; had pCR after neoadjuvant therapy but with tumor size ≥ 5cm or N stage ≥2; or tumor size less than 2cm but with high Ki67; histologic grade 3 or with lymph node micrometastasis.
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
- •Women aged 18-75 years old
- •HER2 positive breast cancer
- •ECOG PS 0-1
- •Known hormone receptor status
- •Completed 1 year of trastuzumab-based adjuvant therapy within 6 months
- •Patients at high risk
排除标准
- •Serious heart disease or discomfort
- •Inability to swallow, intestinal obstruction, or the presence of other factors that interfere with drug administration and absorption
- •Known allergic history of drug components of this regimen
- •A history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation
- •Pregnant and lactating female patients
研究组 & 干预措施
Pyrotinib 400mg/day
High risk HER2 positive patients receive pyrotinib 400mg/day for half or one year
干预措施: Pyrotinib (Drug)
结局指标
主要结局
iDFS
时间窗: From date of receiving drug until the date of first documented invasive disease or date of death from any cause, whichever came first, assessed up to 60 months
INVASIVE DISEASE FREE SURVIVAL
次要结局
- Adverse events(through study completion, an average of 5 years)
- OS(From date of receiving drug until the date of death from any cause, assessed up to 60 months)
研究者
Haihua Yang
Chief Physician
Taizhou Hospital