{"preliminary_commentary":{"by_channel":{"x_thread":2,"podcast":1,"bluesky_thread":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"name":"TroFuse-011","nct_id":"NCT06841354","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=trofuse-011-nct06841354. 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":"Participants receive sacituzumab tirumotecan intravenously (IV) at a dose of 4 mg/kg every 2 weeks (Q2W) until disease progression, toxicity or discontinuation.","label":"Arm A: Sacituzumab Tirumotecan","type":"EXPERIMENTAL"},{"description":"Participants receive sacituzumab tirumotecan IV 4 mg/kg Q2W until disease progression, toxicity or discontinuation PLUS pembrolizumab IV 400 mg every 6 weeks (Q6W) for up to 18 administrations (up to \\~2 years).","label":"Arm B: Sacituzumab Tirumotecan + Pembrolizumab","type":"EXPERIMENTAL"},{"description":"Participants receive physician's choice of chemotherapy agent(s): paclitaxel IV 80 mg/m\\^2 once every week (Q1W) OR paclitaxel IV 90 mg/m\\^2 on Days 1, 8, and 15, every 4 weeks (Q4W) OR nab-paclitaxel IV 100 mg/m\\^2 on Days 1, 8, and 15, Q4W OR gemcitabine IV 1000 mg/m\\^2 on Days 1 and 8, every 3 weeks (Q3W) PLUS carboplatin IV area under the curve (AUC) 2 mg/mL/min on Days 1 and 8, Q3W, until disease progression, toxicity or discontinuation.","label":"Arm C: Treatment of Physician's Choice (TPC)","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2030-05-18","type":"ESTIMATED"},"conditions":["Triple Negative Breast Neoplasms"],"enrollment":{"count":1000,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Sacituzumab tirumotecan","otherNames":["Sac-TMT","MK-2870"],"type":"BIOLOGICAL"},{"name":"Pembrolizumab","otherNames":["MK-3475","Keytruda®"],"type":"BIOLOGICAL"},{"name":"Rescue Medication","otherNames":[],"type":"DRUG"},{"name":"Paclitaxel","otherNames":["Taxol","Onxol"],"type":"DRUG"},{"name":"Nab-paclitaxel","otherNames":["Abraxane"],"type":"DRUG"},{"name":"Gemcitabine","otherNames":["Gemzar"],"type":"DRUG"},{"name":"Carboplatin","otherNames":["Paraplatin"],"type":"DRUG"}],"last_update":"2026-10-13","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less Than 10 (TroFuse-011)","overall_status":"RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2030-05-18","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Progression-Free Survival (PFS) (sac-TMT versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus TPC)","timeFrame":"Up to ~39 months"},{"measure":"Overall Survival (OS) (sac-TMT versus TPC)","timeFrame":"Up to ~61 months"}],"references":[{"citation":"Rugo HS, Schmid P, Cortes J, Takano T, Fasching PA, Park YH, Bianchini G, Franco SX, Villarreal-Garza C, Tredan O, Yin Y, Barroso-Sousa R, Peng X, Malhotra U, Smith KL, Bardia A. TroFuse-011 study design: sacituzumab tirumotecan with or without pembrolizumab for advanced triple-negative breast cancer with PD-L1 CPS <10. Future Oncol. 2026 Aug;22(18):2121-2129. doi: 10.1080/14796694.2026.2701483. Epub 2026 Jul 31.","pmid":"42535874","type":"DERIVED"}],"start_date":{"date":"2025-03-16","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)","url":"https://clinicaltrials.gov/study/NCT06841354"},"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/trofuse-011-nct06841354"}