{"preliminary_commentary":{"by_channel":{"x_thread":6},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"NCT05347134","nct_id":"NCT05347134","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct05347134. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"5 mg/kg, IV (in the vein) on day 1 and Day 15 of each 28 day cycle.","label":"SKB264","type":"ACTIVE_COMPARATOR"},{"description":"Eribulin:1.4mg/m2, IV (in the vein) on day 1 and Day 8 of each 21 day cycle.\n\nCapecitabine:1000-1250mg/m2, po,bid, from day 1 to Day 15 of each 21 day cycle.\n\nGemcitabine:800-1000 mg/m2, IV (in the vein) on day 1 and Day 8 of each 21day cycle.\n\nVinorelbine:25 mg/m2, IV (in the vein) on day 1 and Day 8 of each 21 day cycle.","label":"Eribulin or Capecitabine or Gemcitabine or Vinorelbine","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2027-06-30","type":"ESTIMATED"},"conditions":["Triple Negative Breast Cancer"],"enrollment":{"count":254,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"SKB264","otherNames":["Eribulin","Capecitabine","Gemcitabine","Vinorelbine"],"type":"DRUG"}],"last_update":"2026-05-08","lead_sponsor":"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","official_title":"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","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2023-11-30","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-free survival (PFS)","timeFrame":"up to 24 months"}],"references":[{"citation":"Fan Y, Ouyang Q, Yin Y, Song L, Wang X, Li W, Li M, Yan X, Wang S, Sun T, Teng Y, Tang X, Tong Z, Sun Z, Ge J, Jin X, Diao Y, Liu G, Xu B. Sacituzumab tirumotecan in previously treated metastatic triple-negative breast cancer: a detailed safety analysis of the randomized OptiTROP-Breast01 study. Breast Cancer Res. 2026 Sep 28;28(1):163. doi: 10.1186/s13058-026-02339-z.","pmid":"42806387","type":"DERIVED"},{"citation":"Yin Y, Fan Y, Ouyang Q, Song L, Wang X, Li W, Li M, Yan X, Wang S, Sun T, Teng Y, Tang X, Tong Z, Sun Z, Ge J, Jin X, Diao Y, Liu G, Xu B. Sacituzumab tirumotecan in previously treated metastatic triple-negative breast cancer: a randomized phase 3 trial. Nat Med. 2025 Jun;31(6):1969-1975. doi: 10.1038/s41591-025-03630-w. Epub 2025 Apr 11.","pmid":"40217078","type":"DERIVED"}],"start_date":{"date":"2022-06-10","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"SKB264 Injection vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer","url":"https://clinicaltrials.gov/study/NCT05347134"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct05347134"}