[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509205":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":57,"collaborators":25,"id":59,"slug":25,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":25,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":25,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"RenJi Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"continuous pyrotinib","ACTIVE_COMPARATOR","pyrotinib 400 mg, orally once daily for one year",[13],"Drug: pyrotinib",{"label":15,"type":16,"description":17,"interventionNames":18},"intermittent pyrotinib","EXPERIMENTAL","pyrotinib 400 mg, 14 days on and 7 days off, every 21 days for 17 cycles",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","pyrotinib","an irreversible anti-HER2 tyrosine kinase inhibitor",[9,15],null,[27],{"name":28,"affiliation":29,"role":30},"Wenjin Yin, M.D.","Renji Hospital, School of Medicine, Shanghai Jiao Tong University","PRINCIPAL_INVESTIGATOR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":25,"email":35},"CONTACT","86(21)58852345","yinwenjin@renji.com",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Qi Lu","86(21)68383364","rjllb3364@163.com",[41],{"facility":42,"status":43,"city":44,"state":25,"zip":45,"country":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Renji Hospital, School of Medicine, Shanghai Jiaotong University","RECRUITING","Shanghai","200127","China",{"type":48,"coordinates":49},"Point",[50,51],121.45806,31.22222,{"lat":51,"lon":50},[54],{"name":55,"role":33,"phone":56,"phoneExt":25,"email":35},"Wenjin Yin","86(21)68385569",{"type":30,"investigatorFullName":55,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Deputy Chief of Breast Surgery Department","100509205",false,"NCT05910398","Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer","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","CORINNE-PI","Inclusion Criteria:\n\n* Aged ≥18;\n* Histologically confirmed invasive HER2 positive breast cancer;\n* Duration from random time to the last use of trastuzumab or T-DM1 ≤3 years;\n* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;\n* Adequate organ functions.\n\nExclusion Criteria:\n\n* Metastatic disease (Stage IV);\n* Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery;\n* Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption;\n* Treated or treating with anti-HER2 tyrosine kinase inhibitor;\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* 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.","ALL","18 Years",{"count":69,"type":70},488,"ESTIMATED","INTERVENTIONAL",[73],"PHASE3","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.",[76],"Breast Cancer Invasive","2025-11-14",{"date":79,"type":80},"2025-11-18","ACTUAL",{"date":82,"type":80},"2023-06-01",{"date":84,"type":70},"2030-08",{"name":5,"class":6},1]