Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer
- Registration Number
- NCT04254263
- Lead Sponsor
- RenJi Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 316
- 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) .
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pyrotinib pyrotinib pyrotinib 400 mg, orally once daily for one year
- Primary Outcome Measures
Name Time Method Invasive Disease-free Survival (iDFS) 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.
- Secondary Outcome Measures
Name Time Method Disease-free Survival (DFS) From randomization until time of event up to 2 years Disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, non-breast primary invasive cancer, ductal carcinoma in situ(DCIS),or distant recurrence and death from any cause
Overall Survival (OS) From randomization until time of event up to 2 years Overall survival is defined as the time from randomization to death from any cause.
Trial Locations
- Locations (1)
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
🇨🇳Shanghai, Shanghai, China