{"entity":{"id":"nct05838066","kind":"trial","name":"Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer","aka":[],"tldr":"A phase 3 trial testing HB1801 in HER2-positive breast cancer, now recruiting.","summary":"Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer is a phase 3 interventional study registered as NCT05838066, led by Shanghai JMT-Bio, and recruiting on the registry. Official title: A Randomised, 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. Planned enrolment is 880 participants (estimated). The study started in 2023-07-23 and primary completion is expected in 2025-07-31. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05838066","url":"https://clinicaltrials.gov/study/NCT05838066"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["hb1801"],"companies":["cspc"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05838066","phase":"3","setting":"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","sponsor":"Shanghai JMT-Bio","started":"2023-07-23","startedType":"actual","enrolled":880,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05838066/","neighbours":{"cancer":[{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"}],"drug":[{"id":"hb1801","kind":"drug","name":"HB1801","route":"/drugs/hb1801/"}],"company":[{"id":"cspc","kind":"company","name":"CSPC Pharmaceutical Group","route":"/companies/cspc/"}]}}