[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618704":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":38,"studyPopulation":38,"armGroups":45,"interventions":60,"overallOfficials":38,"centralContacts":78,"locations":84,"responsibleParty":100,"collaborators":38,"id":104,"slug":38,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":38,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":38,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":87,"whyStopped":38,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Shanghai Jiao Tong University School of Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"ctDNA clearance after one cycle neoadjuvant treatment","The rate of ctDNA clearance after first cycle of neoadjuvant treatment","3 months after neoadjuvant treatment initation",[14,17,21,24,27,31,34],{"measure":15,"description":16,"timeFrame":12},"ctDNA clearance after two cycle neoadjuvant treatment","The rate of ctDNA clearance after first two cycles of neoadjuvant treatments",{"measure":18,"description":19,"timeFrame":20},"pCR rate","After completion of neoadjuvant therapy and surgery, no residual invasive carcinoma in the evaluation of hematoxylin and eosin stained mamtectomy samples and all ipsilateral lymph node samples","6 months after neoadjuvant treatment initation",{"measure":22,"description":23,"timeFrame":20},"bpCR rate","After completion of neoadjuvant therapy and surgery, no residual invasive carcinoma in the evaluation of hematoxylin and eosin stained breast samples",{"measure":25,"description":26,"timeFrame":20},"ORR","The proportion of patients whose tumor volume shrinks to a prespecified value and is able to maintain the minimum time limit, defined as the sum of the proportion of complete response (CR) and partial response (PR, with a reduction in tumor length and diameter greater than 30%).",{"measure":28,"description":29,"timeFrame":30},"EFS","The time interval from randomization to the first recording of the following events: disease progression (before surgery), as determined by investigator reference RECIST1.1, combined with clinical evaluation, final judgment; postoperative disease recurrence (local, regional, distal, or contralateral); second primary malignancy; Death from any cause","2 years after surgery",{"measure":32,"description":33,"timeFrame":30},"DFS","The time interval from the first date of disease-free (i.e., the date of surgery) to the first recording of the following events; Postoperative disease recurrence (local, regional, distal, or contralateral); second primary malignancy; Death from any cause.",{"measure":35,"description":36,"timeFrame":37},"OS","Time interval from randomization to death from any cause.","5 years after surgery",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":38,"primaryPurpose":42,"observationalModel":38,"timePerspective":38,"maskingInfo":43},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":44,"maskingDescription":38,"whoMasked":38},"NONE",[46,55],{"label":47,"type":48,"description":49,"interventionNames":50},"Pyrotinib-initiated arm","EXPERIMENTAL","two cycles of docetaxel + trastuzumab + pyrotinib followed by two cycles of docetaxel + trastuzumab + pertuzumab",[51,52,53,54],"Drug: pyrotinib","Drug: pertuzumab","Drug: trastuzumab","Drug: docetaxel",{"label":56,"type":57,"description":58,"interventionNames":59},"Pertuzumab-initiated arm","ACTIVE_COMPARATOR","four cycles of docetaxel + trastuzumab + pertuzumab",[52,53,54],[61,66,70,74],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":38},"DRUG","pyrotinib","pyrotinib 320mg p.o. qd",[47],{"type":62,"name":67,"description":68,"armGroupLabels":69,"otherNames":38},"pertuzumab","pertuzumab ivgtt q3w, 840mg for initiation, 420mg for maintenance",[56,47],{"type":62,"name":71,"description":72,"armGroupLabels":73,"otherNames":38},"trastuzumab","trastuzumab ivgtt q3w, 8mg\u002Fkg for initiation, 6mg\u002Fkg for maintenance",[56,47],{"type":62,"name":75,"description":76,"armGroupLabels":77,"otherNames":38},"docetaxel","docetaxel ivgtt q3w, 80-100mg\u002Fm2",[56,47],[79],{"name":80,"role":81,"phone":82,"phoneExt":38,"email":83},"Haoyu Wang","CONTACT","86 18817865256","meredithwhy@163.com",[85],{"facility":86,"status":87,"city":88,"state":38,"zip":89,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"Ruijin Hospital","RECRUITING","Shanghai","200025","China","CN",{"type":93,"coordinates":94},"Point",[95,96],121.45806,31.22222,{"lat":96,"lon":95},[99],{"name":80,"role":81,"phone":82,"phoneExt":38,"email":83},{"type":101,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"PRINCIPAL_INVESTIGATOR","Kunwei Shen","Professor","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":114,"type":115},60,"ESTIMATED","INTERVENTIONAL",[118],"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",[121],"Breast Cancer",[123,124,125,126],"Breast cancer","Neoadjuvant therapy","HER2 positive","ctDNA","2026-03-20",{"date":129,"type":130},"2026-03-24","ACTUAL",{"date":132,"type":130},"2024-02-01",{"date":134,"type":115},"2026-12-31",{"name":5,"class":6},1]