[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100382025":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":38,"responsibleParty":57,"collaborators":18,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":18,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":18,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"RenJi Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pyrotinib","EXPERIMENTAL","pyrotinib 400 mg, orally once daily for one year",[13],"Drug: pyrotinib",{"label":15,"type":16,"description":17,"interventionNames":18},"No Pyrotinib","NO_INTERVENTION","Observation follow-up",null,[20],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":18},"DRUG","pyrotinib",[9],[25],{"name":26,"affiliation":5,"role":27},"Jinsong Lu","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},"Wenjin Yin","CONTACT","86(21)68385569","followroad@163.com",{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},"Qi Lu","86(21)68383364","rjllb3364@163.com",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Renji Hospital, School of Medicine, Shanghai Jiao Tong University","RECRUITING","Shanghai","Shanghai Municipality","200127","China","CN",{"type":48,"coordinates":49},"Point",[50,51],121.45806,31.22222,{"lat":51,"lon":50},[54],{"name":55,"role":31,"phone":18,"phoneExt":18,"email":56},"Jinsong Lu, MD","lujjss@163.com",{"type":27,"investigatorFullName":30,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Deputy Chief of Breast Surgery Department","100382025","phase-3-adjuvant-study-of-pyrotinib-in-her-2-positive-breast-cancer-100382025",false,"NCT04254263","Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer","Adjuvant Trastuzumab Plus Pyrotinib for Residual Invasive HER2-positive Breast Cancer After Neoadjuvant Chemotherapy Plus Anti-HER2 Target Therapy","ATP","Inclusion Criteria:\n\n* Female, Aged ≥18 and ≤70 years;\n* Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ⅡA-Ⅲ) ;\n* Completed neoadjuvant therapy, including chemotherapy and trastuzumab;\n* Residual invasive disease was detected pathologically in the surgical specimen of the breast or axillary lymph nodes after completion of neoadjuvant chemotherapy;\n* Been or being treated for early breast cancer with standard of care duration of trastuzumab;\n* Adjuvant treatment regimen needs to be determined before randomization;\n* Duration from Random time to the last use of trastuzumab≤1 year.\n* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;\n* Required laboratory values including following parameters:ANC: ≥ 1.5 x 109\u002FL; Platelet count: ≥ 100 x 109\u002FL; Hemoglobin: ≥ 9.0 g\u002FdL; Total bilirubin: ≤ 1.5 x upper limit of normal, ULN; ALT and AST: ≤ 1.5 x ULN; BUN and creatine clearance rate: ≥ 50 mL\u002Fmin; LVEF: ≥ 50%; QTcF: \\\u003C 470 ms\n* Signed informed consent form (ICF) .\n\nExclusion Criteria:\n\n* Metastatic disease (Stage IV) ;\n* Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery;\n* Progressive disease during neoadjuvant therapy;\n* Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption;\n* Treated or treating with anti-HER2 TKI, including but not limited to pyrotinib, lapatinib and neratinib.\n* Less than 4 weeks from the last clinical trial;\n* History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation;\n* 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;\n* 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;\n* 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.","FEMALE","18 Years","70 Years",{"count":71,"type":72},316,"ESTIMATED","INTERVENTIONAL",[75],"PHASE3","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.",[78],"Locally Advanced Breast Cancer","2025-09-10",{"date":81,"type":82},"2025-09-11","ACTUAL",{"date":84,"type":82},"2019-12-16",{"date":86,"type":72},"2028-08",{"name":5,"class":6},1]