{"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 is a phase 3 interventional study registered as NCT05347134 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 254 participants enrolled, started 2022-06-10 and due to reach its primary completion in 2023-11-30. Interventions recorded: SKB264.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05347134","url":"https://clinicaltrials.gov/study/NCT05347134"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["kelun-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05347134-nat-med-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05347134","phase":"3","setting":"A Randomized, Controlled, Open-label, Multi-center Phase III Clinical Trial of SKB264 for Injection Versus Investigator Selected Regimens in Patients With Unresectable Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer Who Have Failed Second-line or Above Prior Standard of Care","sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","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/"}],"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/"}]}}