Adjuvant Trastuzumab Plus Pyrotinib for Residual Invasive HER2-positive Breast Cancer After Neoadjuvant Chemotherapy Plus Anti-HER2 Target Therapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 316
- 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, multicenter, no placebo-controlled, open label study for evaluating the efficacy and safety of pyrotinib in women with residual invasive HER2-positive breast cancer after neoadjuvant chemotherapy plus anti-HER2 target therapy. The main purpose is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer based on the 1-year trastuzumab standard adjuvant treatment with or without pertuzumab.
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 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) ;
- •Completed neoadjuvant therapy, including chemotherapy and trastuzumab;
- •Residual invasive disease was detected pathologically in the surgical specimen of the breast or axillary lymph nodes after completion of neoadjuvant chemotherapy;
- •Been or being treated for early breast cancer with standard of care duration of trastuzumab;
- •Adjuvant treatment regimen needs to be determined before randomization;
- •Duration from Random time to the last use of trastuzumab≤1 year.
- •Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
- •Required laboratory values including following parameters:ANC: ≥ 1.5 x 109/L; Platelet count: ≥ 100 x 109/L; Hemoglobin: ≥ 9.0 g/dL; Total bilirubin: ≤ 1.5 x upper limit of normal, ULN; ALT and AST: ≤ 1.5 x ULN; BUN and creatine clearance rate: ≥ 50 mL/min; LVEF: ≥ 50%; QTcF: < 470 ms
- •Signed informed consent form (ICF) .
排除标准
- •Metastatic disease (Stage IV) ;
- •Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery;
- •Progressive disease during neoadjuvant therapy;
- •Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption;
- •Treated or treating with anti-HER2 TKI, including but not limited to pyrotinib, lapatinib and neratinib.
- •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;
- •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
Pyrotinib
pyrotinib 400 mg, orally once daily for one year
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)
- 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