Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer: a Prospective, Randomised, Controlled, Multicentre Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 488
- 试验地点
- 1
- 主要终点
- Invasive Disease-free Survival (iDFS)
研究概览
简要总结
This is a prospective, randomised, controlled, multicentre study to compare the efficacy and safety between continuous or intermittent extension of adjuvant pyrotinib in invasive human epidermal growth factor receptor 2 (HER2)-positive 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
- Single (Outcomes Assessor)
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
- •Aged ≥18;
- •Histologically confirmed invasive HER2 positive breast cancer;
- •Duration from random time to the last use of trastuzumab or T-DM1 ≤3 years;
- •Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
- •Adequate organ functions.
排除标准
- •Metastatic disease (Stage IV);
- •Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery;
- •Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption;
- •Treated or treating with anti-HER2 tyrosine kinase inhibitor;
- •Less than 4 weeks from the last clinical trial;
- •History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation;
- •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
continuous pyrotinib
pyrotinib 400 mg, orally once daily for one year
干预措施: pyrotinib (Drug)
intermittent pyrotinib
pyrotinib 400 mg, 14 days on and 7 days off, every 21 days for 17 cycles
干预措施: pyrotinib (Drug)
结局指标
主要结局
Invasive Disease-free Survival (iDFS)
时间窗: From randomization until time of event up to 2 years.
Invasive disease-free survival time is defined as the time from date of randomization until the first invasive disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.
次要结局
- Disease-free Survival (DFS)(From randomization until time of event up to 2 years)
- Adverse events(From the date of starting pyrotinib to the end of the treatment (up to approximately 1 year))
- Overall Survival (OS)(From randomization until time of event up to 2 years)
研究者
Wenjin Yin
Deputy Chief of Breast Surgery Department
RenJi Hospital