{"entity":{"id":"nct05347134","kind":"trial","name":"SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer","aka":[],"tldr":"A phase 3 trial of SKB264 in triple-negative breast cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., active and no longer recruiting.","summary":"SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer. ClinicalTrials.gov record last updated 2026-05-08: active not recruiting. Enrollment is planned at 254 participants. Primary completion is actual at 2023-11-30. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications. Registered interventions: SKB264. Registered primary measures: Progression-free survival (PFS).","status":"active","asOf":"2026-10-06","links":[{"label":"ClinicalTrials.gov NCT05347134","url":"https://clinicaltrials.gov/study/NCT05347134"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":[],"targets":["trop2"],"drugs":[],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05347134-nat-med-2025"],"journals":[],"dependsOn":[],"notes":["ClinicalTrials.gov record last updated 2026-05-08: active not recruiting. Enrollment is planned at 254 participants. Primary completion is actual at 2023-11-30. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications."],"nct":"NCT05347134","phase":"3","setting":"SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","participation":[{"nct":"NCT05347134","source":"https://clinicaltrials.gov/study/NCT05347134","fetchedAt":"2026-10-07T16:53:40.482Z","studySha256":"fa2f2d4e98cc1cd05d5c99ffbb028d3625115dab7440f0e0dd69ac8d02bb245a","overallStatus":"ACTIVE_NOT_RECRUITING","lastUpdatePosted":"2026-05-08","leadSponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","collaboratorCount":0,"minimumAge":"18 Years","maximumAge":"75 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":254,"enrolmentType":"ESTIMATED","siteCount":2,"recruitingSiteCount":0,"countries":["China"]}],"started":"2022-06-10","startedType":"actual","enrolled":254,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05347134/","neighbours":{"cancer":[{"id":"tnbc-metastatic","kind":"cancer","name":"Metastatic triple-negative breast cancer","route":"/cancers/tnbc-metastatic/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"target":[{"id":"trop2","kind":"target","name":"TROP2","route":"/targets/trop2/"}],"company":[{"id":"kelun-biotech","kind":"company","name":"Sichuan Kelun-Biotech","route":"/companies/kelun-biotech/"}],"paper":[{"id":"paper-nct05347134-nat-med-2025","kind":"paper","name":"Sacituzumab tirumotecan in previously treated metastatic triple-negative breast cancer: a randomized phase 3 trial","route":"/key-papers/paper-nct05347134-nat-med-2025/"}]}}