{"commentary":{"count":219,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":79,"youtube":76,"podcast":64},"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\": \"NCT05104866\", \"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":"NCT05104866","nct_id":"NCT05104866","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct05104866. 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":null,"arms":[{"description":"Arm 1: Dato-DXd","label":"Dato-DXd","type":"EXPERIMENTAL"},{"description":"Arm 2: ICC\n\nCapecitabine\n\nGemcitabine\n\nEribulin mesylate\n\nVinorelbine","label":"Investigators Choice of Chemotherapy (ICC)","type":"ACTIVE_COMPARATOR"}],"collaborators":["Daiichi Sankyo"],"completion_date":{"date":"2026-12-31","type":"ESTIMATED"},"conditions":["Breast Cancer"],"enrollment":{"count":732,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Dato-DXd","type":"DRUG"},{"name":"Capecitabine","type":"DRUG"},{"name":"Gemcitabine","type":"DRUG"},{"name":"Eribulin","type":"DRUG"},{"name":"Vinorelbine","type":"DRUG"}],"last_update":"2026-08-24","lead_sponsor":"AstraZeneca","official_title":"A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2024-07-24","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-Free Survival","timeFrame":"On-study tumor assessments occur every 6 weeks then every 9 weeks until disease progression, death or withdrawal of consent assessed up to data cut-off (17Jul2023) to a maximum of approximately 21 months"},{"measure":"Overall Survival","timeFrame":"From date of randomization until death due to any cause. Assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months."}],"references":[{"citation":"Bardia A, Jhaveri K, Im SA, Pernas S, De Laurentiis M, Wang S, Martinez Janez N, Borges G, Cescon DW, Hattori M, Lu YS, Hamilton E, Zhang Q, Tsurutani J, Kalinsky K, Rubini Liedke PE, Xu L, Fairhurst RM, Khan S, Denduluri N, Rugo HS, Xu B, Pistilli B; TROPION-Breast01 Investigators. Datopotamab Deruxtecan Versus Chemotherapy in Previously Treated Inoperable/Metastatic Hormone Receptor-Positive Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer: Primary Results From TROPION-Breast01. J Clin Oncol. 2025 Jan 20;43(3):285-296. doi: 10.1200/JCO.24.00920. Epub 2024 Sep 12.","pmid":"39265124","type":"DERIVED"},{"citation":"Bardia A, Jhaveri K, Kalinsky K, Pernas S, Tsurutani J, Xu B, Hamilton E, Im SA, Nowecki Z, Sohn J, Laurentiis M, Janez NM, Adamo B, Lee KS, Jung KH, Rubovszky G, Tseng LM, Lu YS, Yuan Y, Maxwell MJ, Haddad V, Khan SS, Rugo HS, Pistilli B. TROPION-Breast01: Datopotamab deruxtecan vs chemotherapy in pre-treated inoperable or metastatic HR+/HER2- breast cancer. Future Oncol. 2024 Mar;20(8):423-436. doi: 10.2217/fon-2023-0188. Epub 2023 Jun 30.","pmid":"37387213","type":"DERIVED"}],"start_date":{"date":"2021-10-18","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)","url":"https://clinicaltrials.gov/study/NCT05104866"},"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/nct05104866"}