Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer: a Prospective, Randomized, Controlled, Multicentre Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
This is a prospective, randomised, controlled, multicentre study to evaluate the efficacy and safety of continuous versus intermittent pyrotinib therapy in patients with human epidermal growth factor receptor (HER2)-positive advanced breast cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years old
- •Pathologically confirmed advanced or locally advanced breast cancer not amenable to curative surgery
- •Pathologically confirmed HER2+ at least once for either primary or metastatic lesion
- •Previously treated with any number of lines for advanced disease and eligible for a pyrotinib-containing regimen at the discretion of physician
- •At least one measurable lesion or bone-only disease (osteolytic or mixed) according to RECIST v1.1
- •Adequate organ function
排除标准
- •During pregnancy and lactation
- •Difficulties with pyrotinib administration or absorption
研究组 & 干预措施
Intermittent pyrotinib
Intermittent use of pyrotinib, 14 days on and 7 days of, every 21 days
干预措施: Pyrotinib (Drug)
Continuous pyroitnib
oral pyrotinib qd
干预措施: Pyrotinib (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: From the date of starting pyrotinib to the date of confirmed CR or PR (up to approximately 1 years)
ORR is the percentage of subjects with complete remission (CR) or partial remission (PR) as the best response during the period from the beginning of the treatment to the progression of the disease or the completion of therapy (CR+PR)/Analysis of the total number of people. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) was used to assess the objective tumor response.
次要结局
- Progression-Free Survival (PFS)(From the date of starting pyrotinib to the date of first documentation of disease progression or death from any cause (up to approximately 1 year))
- Adverse events(From the date of starting pyrotinib to the end of the treatment (up to approximately 1 year))
研究者
Wenjin Yin
Deputy Chief of Breast Surgery Department
RenJi Hospital