{"entity":{"id":"nct07377643","kind":"trial","name":"IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer","aka":[],"tldr":"A phase 3 trial testing IBI354 in HER2-positive breast cancer, now recruiting.","summary":"IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer is a phase 3 interventional study registered as NCT07377643, led by Innovent Biopharmaceutical Technology (Hangzhou), and recruiting on the registry. Official title: A Randomised, Multicenter, Open-label Phase 3 Study to Compare IBI354 With or Without Pertuzumab vs. Taxane in Combination With Trastuzumab and Pertuzumab as First-line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Breast Cancer. Planned enrolment is 540 participants (estimated). The study started in 2026-02-10 and primary completion is expected in 2028-04-28. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07377643","url":"https://clinicaltrials.gov/study/NCT07377643"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["ibi354"],"companies":["innovent"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07377643","phase":"3","setting":"A Randomized, Multicenter, Open-label Phase 3 Study to Compare IBI354 With or Without Pertuzumab vs. Taxane in Combination With Trastuzumab and Pertuzumab as First-line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Breast Cancer","sponsor":"Innovent Biopharmaceutical Technology (Hangzhou)","participation":[{"nct":"NCT07377643","source":"https://clinicaltrials.gov/study/NCT07377643","fetchedAt":"2026-10-07T16:55:42.201Z","studySha256":"0ab525333273d671a24299229810a324286c850d359ba6cda072fdfeb7e17709","overallStatus":"RECRUITING","lastUpdatePosted":"2026-02-25","leadSponsor":"Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":540,"enrolmentType":"ESTIMATED","siteCount":1,"recruitingSiteCount":1,"countries":["China"]}],"started":"2026-02-10","startedType":"actual","enrolled":540,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct07377643/","neighbours":{"cancer":[{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"}],"drug":[{"id":"ibi354","kind":"drug","name":"IBI354","route":"/drugs/ibi354/"}],"company":[{"id":"innovent","kind":"company","name":"Innovent Biologics","route":"/companies/innovent/"}]}}