[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503654":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":45,"locations":55,"responsibleParty":72,"collaborators":29,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":29,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":29,"enrollmentInfo":83,"targetDuration":29,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":29,"overallStatus":58,"whyStopped":29,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Shanghai JMT-Bio Inc.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"KN026+HB1801","EXPERIMENTAL","Subjects will receive an intravenous (IV) infusion of KN026 plus HB1801. All subjects are required to receive study treatment as planned until investigator-assessed loss of benefit, toxic intolerance, withdrawal of consent, loss to follow-up, or death, whichever occurrs first.",[13,14],"Drug: Recombinant Humanized Bispecific antibody against HER2，KN026","Drug: HB1801",{"label":16,"type":17,"description":18,"interventionNames":19},"Trastuzumab + Pertuzumab + Docetaxel","ACTIVE_COMPARATOR","On Day 1 of each 21-day cycle, patients will receive an intravenous (IV) infusion of Pertuzumab 840 mg loading dose followed by 420 mg per cycle, IV, D1, Q3W, in combination with trastuzumab 8 mg\u002Fkg loading dose followed by 6 mg\u002Fkg per cycle, IV, D1, Q3W and docetaxel 75 mg\u002Fm\\^2. All subjects are required to receive study treatment as planned until investigator-assessed loss of benefit, toxic intolerance, withdrawal of consent, loss to follow-up, or death, whichever occurred first.",[20,21,22],"Drug: Pertuzumab","Drug: Trastuzumab","Drug: Docetaxel",[24,30,33,37,41],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Recombinant Humanized Bispecific antibody against HER2，KN026","IV infusion",[9],null,{"type":25,"name":31,"description":27,"armGroupLabels":32,"otherNames":29},"HB1801",[9],{"type":25,"name":34,"description":35,"armGroupLabels":36,"otherNames":29},"Pertuzumab","840 mg loading dose followed by 420 mg per cycle, D1 Q3W, IV infusion",[16],{"type":25,"name":38,"description":39,"armGroupLabels":40,"otherNames":29},"Trastuzumab","8 mg\u002Fkg loading dose followed by 6 mg\u002Fkg per cycle, D1 Q3W, IV infusion",[16],{"type":25,"name":42,"description":43,"armGroupLabels":44,"otherNames":29},"Docetaxel","75 mg\u002Fm\\^2, D1 Q3W, IV infusion",[16],[46,51],{"name":47,"role":48,"phone":49,"phoneExt":29,"email":50},"Clinical Trials Information Group Officer","CONTACT","+86-0311-69085587","ctr-contact@mail.ecspc.com",{"name":52,"role":48,"phone":53,"phoneExt":29,"email":54},"fenglin She","18301190515","shefenglin@cspc.cn",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":29,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Clinical Trials Information Group","RECRUITING","Beijing","chaoyang","China","CN",{"type":64,"coordinates":65},"Point",[66,67],116.39723,39.9075,{"lat":67,"lon":66},[70,71],{"name":47,"role":48,"phone":49,"phoneExt":29,"email":50},{"name":47,"role":48,"phone":49,"phoneExt":29,"email":29},{"type":73,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100503654","phase-3-efficacy-and-safety-of-kn026-in-combination-with-hb1801-in-the-first-line-treatment-of-subjects-with-her2-positive-recurrent-or-metastatic-breast-cancer-100503654",false,"NCT05838066","Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.","A Randomized, Controlled, Open-label, Multicenter, Phase Ш Clinical Study of the Efficacy and Safety of KN026 in Combination With HB1801 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.","Key Inclusion Criteria:\n\n* Voluntarily enrolled in this study and signed an informed consent form (ICF).\n* Age ≥ 18 years.\n* Recurrent or metastatic breast cancer confirmed by histology and\u002For cytology.\n* Latest tumor tissue sample confirmed as HER2 positive by central laboratory testing.\n* No prior systemic chemotherapy and\u002For HER2-targeted therapy for recurrent or metastatic breast cancer.\n* Eastern Cooperative Oncology Group (ECOG) physical status score of 0 - 1.\n* Presence of lesion (RECIST 1.1).\n* Adequate organ and bone marrow function\n\nKey Exclusion Criteria:\n\n* Ineligible for any of the agents on the study\n* Untreated or unstable parenchymal metastases, spinal cord metastases or compression, or carcinomatous encephalitis.\n* Pregnant or lactating women.\n* Presence of other circumstances that may interfere with the subject's participation in the study procedures or are inconsistent with the maximum benefit of the subject's participation in the study or affect the results of the study: e.g., history of mental illness, drug or substance abuse, any other disease or condition of clinical significance, etc.","ALL","18 Years",{"count":84,"type":85},880,"ESTIMATED","INTERVENTIONAL",[88],"PHASE3","This is a randomized, controlled, open-label, multicenter, phase Ш clinical study designed to compare the efficacy and safety of KN026 in combination with HB1801 to trastuzumab in combination with pertuzumab and docetaxel in the first-line treatment of subjects with HER2-positive recurrent or metastatic breast cancer. The statistical assumption for this study is superiority. The primary study endpoint was PFS as assessed by Blinded Independ Review Committee (BIRC).",[91],"First-line Treatment of HER2-positive Recurrent or Metastatic Breast Cancer","2025-05-26",{"date":94,"type":95},"2025-05-30","ACTUAL",{"date":97,"type":95},"2023-07-23",{"date":99,"type":85},"2027-12-31",{"name":5,"class":6},1]