[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618704":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":41,"locations":47,"responsibleParty":63,"collaborators":28,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":28,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":28,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":50,"whyStopped":28,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Shanghai Jiao Tong University School of Medicine","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Pyrotinib-initiated arm","EXPERIMENTAL","two cycles of docetaxel + trastuzumab + pyrotinib followed by two cycles of docetaxel + trastuzumab + pertuzumab",[13,14,15,16],"Drug: pyrotinib","Drug: pertuzumab","Drug: trastuzumab","Drug: docetaxel",{"label":18,"type":19,"description":20,"interventionNames":21},"Pertuzumab-initiated arm","ACTIVE_COMPARATOR","four cycles of docetaxel + trastuzumab + pertuzumab",[14,15,16],[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","pyrotinib","pyrotinib 320mg p.o. qd",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"pertuzumab","pertuzumab ivgtt q3w, 840mg for initiation, 420mg for maintenance",[18,9],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"trastuzumab","trastuzumab ivgtt q3w, 8mg\u002Fkg for initiation, 6mg\u002Fkg for maintenance",[18,9],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"docetaxel","docetaxel ivgtt q3w, 80-100mg\u002Fm2",[18,9],[42],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},"Haoyu Wang","CONTACT","86 18817865256","meredithwhy@163.com",[48],{"facility":49,"status":50,"city":51,"state":28,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Ruijin Hospital","RECRUITING","Shanghai","200025","China","CN",{"type":56,"coordinates":57},"Point",[58,59],121.45806,31.22222,{"lat":59,"lon":58},[62],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Kunwei Shen","Professor","100618704","phase-2-ctdna-in-her2-ebc-neoadjuvant-treatment-100618704",false,"NCT07335081","ctDNA in HER2+ EBC Neoadjuvant Treatment","A Randomized, Multicenter, Open-label Clinical Study Using Peripheral Blood Circulating Tumor DNA to Evaluate the Efficacy of Preoperative Treatment With Pyrotinib + Trastuzumab + Docetaxel Versus Pertuzumab + Trastuzumab + Docetaxel in Early or Locally Advanced HER2-positive Breast Cancer","Inclusion Criteria:\n\n* histologically diagnosed with Stage II-III HER2+ breast cancer (primary diameter \\>2cm)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Intact renal, hepatic, bone marrow and cardiac functions including baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography\n* No prior treatment\n\nExclusion Criteria:\n\n* Bilateral or metastatic breast cancer\n* History of other malignancies\n* Severe cardiovascular disease\n* Allergic to any of the regimens","FEMALE","18 Years","70 Years",{"count":78,"type":79},60,"ESTIMATED","INTERVENTIONAL",[82],"PHASE2","This study is a randomized, open-label, multicenter clinical study for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer, aiming to compare the peripheral blood ctDNA clearance of neoadjuvant pyrotinib + trastuzumab + docetaxel and pertuzumab + trastuzumab + docetaxel for one course and to evaluate the therapeutic effectiveness of four courses of neoadjuvant therapy",[85],"Breast Cancer",[87,88,89,90],"Breast cancer","Neoadjuvant therapy","HER2 positive","ctDNA","2026-03-20",{"date":93,"type":94},"2026-03-24","ACTUAL",{"date":96,"type":94},"2024-02-01",{"date":98,"type":79},"2026-12-31",{"name":5,"class":6},1]