{"commentary":{"count":77,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":45,"youtube":17,"podcast":15},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04527991\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"TROPiCS-04","nct_id":"NCT04527991","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=tropics-04-nct04527991. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":"TROPiCS-04","arms":[{"description":"Participants will receive 10 mg/kg of SG intravenously (IV) on Day 1 and Day 8 of each 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion is met.","label":"Sacituzumab Govitecan-hziy (SG)","type":"EXPERIMENTAL"},{"description":"Participants will receive 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and will continue to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion is met.\n\nPaclitaxel 175 mg/m\\^2 IV on Day 1 of every 21-day cycle or Docetaxel 75 mg/m\\^2 IV on Day 1 of every 21-day cycle or Vinflunine 320 mg/m\\^2 IV on Day 1 of every 21-day cycle (in countries where vinflunine was approved and was commercially available).","label":"Treatment of Physician's Choice","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2025-07-04","type":"ACTUAL"},"conditions":["Locally Advanced or Metastatic Unresectable Urothelial Cancer"],"enrollment":{"count":711,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Sacituzumab Govitecan-hziy","type":"DRUG"},{"name":"Paclitaxel","type":"DRUG"},{"name":"Docetaxel","type":"DRUG"},{"name":"Vinflunine","type":"DRUG"}],"last_update":"2026-06-02","lead_sponsor":"Gilead Sciences","official_title":"A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Subjects With Metastatic or Locally Advanced Unresectable Urothelial Cancer","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2025-07-04","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall Survival (OS)","timeFrame":"Up to 42 months"}],"references":[{"citation":"Powles T, Tagawa S, Vulsteke C, Gross-Goupil M, Park SH, Necchi A, De Santis M, Duran I, Morales-Barrera R, Guo J, Sternberg CN, Bellmunt J, Goebell PJ, Kovalenko M, Boateng F, Sierecki M, Wang L, Sima CS, Waldes J, Loriot Y, Grivas P. Sacituzumab govitecan in advanced urothelial carcinoma: TROPiCS-04, a phase III randomized trial. Ann Oncol. 2025 May;36(5):561-571. doi: 10.1016/j.annonc.2025.01.011. Epub 2025 Feb 11.","pmid":"39934055","type":"BACKGROUND"},{"citation":"Grivas P, Tagawa S, Bellmunt J, De Santis M, Duran I, Goebell PJ, et al. TROPiCS-04: Study of Sacituzumab Govitecan in Metastatic or Locally Advanced Unresectable Urothelial Cancer That Has Progressed After Platinum and Checkpoint Inhibitor Therapy. [Poster TPS498]. American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU); 2021 February 11-13; Virtual meeting.","pmid":null,"type":"BACKGROUND"},{"citation":"Grivas P., Powles T., Vulsteke C., Gross-Goupil M., Park S. et al. LBA9 TROPiCS-04, a randomized phase III study of sacituzumab govitecan (SG) vs chemotherapy (CT) in pretreated advanced urothelial carcinoma (aUC): Overall survival (OS) and safety analysis. Annals of Oncology, Volume 35, Supplement 4, S1505-S1507, December 2024.","pmid":null,"type":"BACKGROUND"},{"citation":"Vulsteke C, Grivas P, Tagawa ST, Bellmunt J, De Santis M, Duran I, et al. TROPiCS-04: Study of Sacituzumab Govitecan (SG) in Patients (Pts) With Locally Advanced (LA) Unresectable or M etastatic Urothelial Cancer (mUC) That Has Progressed After Prior Platinum (PLT) and Checkpoint Inhibitor (CPI) Therapy. [Poster TPS582]. American Society of Clinical Oncology Genitourinary (ASCO-GU); 2022 February 17-19; Annual Meeting.","pmid":null,"type":"BACKGROUND"},{"citation":"Powles T, Tagawa ST, Vulsteke C, Gross-Goupil M, Park SH, Necchi A, De Santis M, Duran I, Morales-Barrera R, Guo J, Sternberg CN, Bellmunt J, Goebell PJ, Kovalenko M, Boateng F, Sierecki M, Wang L, Sima CS, Waldes J, Bangs R, Loriot Y, Grivas P. A plain language summary of the TROPiCS-04 study: sacituzumab govitecan use after platinum-based chemotherapy and immunotherapy in people with locally advanced or metastatic cancer of the bladder, urethra, or upper urinary tract. Future Oncol. 2025 Dec;21(28):3593-3610. doi: 10.1080/14796694.2025.2579003. Epub 2025 Nov 23.","pmid":"41277126","type":"DERIVED"},{"citation":"Klumper N, Cox A, Sjodahl G, Roghmann F, Bolenz C, Hartmann A, Grunwald V, Faltas BM, Holzel M, Eckstein M. Pre-treatment metastatic biopsy: a step towards precision oncology for urothelial cancer. Nat Rev Urol. 2025 May;22(5):256-267. doi: 10.1038/s41585-024-00951-2. Epub 2024 Oct 29.","pmid":"39472646","type":"DERIVED"}],"start_date":{"date":"2021-01-13","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Sacituzumab Govitecan Versus Physician's Choice of Treatment in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread","url":"https://clinicaltrials.gov/study/NCT04527991"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/tropics-04-nct04527991"}