{"preliminary_commentary":{"by_channel":{"bluesky_thread":4,"x_thread":1},"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":"NCT04468061","nct_id":"NCT04468061","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04468061. 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 will receive Sacituzumab Govitecan + Pembrolizumab at a pre-determined dose during a 21 day cycle.\n\nSacituzumab Govitecan will be given on days 1 and 8 of the 21 day cycle Pembrolizumab will be given on day 1 of the 21 day cycle.","label":"Sacituzumab Govitecan + Pembrolizumab","type":"EXPERIMENTAL"},{"description":"Participants will receive Sacituzumab Govitecan at a pre-determined dose during a 21 day cycle.\n\nSacituzumab Govitecan will be given on days 1 and 8 of a 21-day cycle","label":"Sacituzumab Govitecan","type":"EXPERIMENTAL"},{"description":"Participants randomized to the combination arm (Sacituzumab Govitecan + Pembrolizumab) who stop with CR after at least 24 weeks of treatment may be eligible for additional pembrolizumab and/or sacituzumab govitecan therapy if they progress after stopping study treatment. This is termed the Second Course Phase and is only available if the study remains open and the subject meets conditions.\n\n.","label":"Retreatment","type":"EXPERIMENTAL"}],"collaborators":["Gilead Sciences","Merck Sharp & Dohme LLC"],"completion_date":{"date":"2029-04-01","type":"ESTIMATED"},"conditions":["Breast Cancer","Triple Negative Breast Cancer","PD-L1 Negative"],"enrollment":{"count":110,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Sacituzumab Govitecan","otherNames":["IMMU-132","Trodelvy"],"type":"DRUG"},{"name":"Pembrolizumab","otherNames":["Keytruda"],"type":"DRUG"}],"last_update":"2026-04-29","lead_sponsor":"Dana-Farber Cancer Institute","official_title":"Saci-IO TNBC: Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in PD-L1-negative Metastatic Triple Negative Breast Cancer (TNBC)","overall_status":"RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2027-04-01","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Progression Free Survival (PFS)","timeFrame":"3 years"}],"references":[{"citation":"Kwapisz D. Sacituzumab Govitecan-hziy in Breast Cancer. Am J Clin Oncol. 2022 Jul 1;45(7):279-285. doi: 10.1097/COC.0000000000000919. Epub 2022 May 12.","pmid":"35728046","type":"DERIVED"}],"start_date":{"date":"2020-07-20","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC","url":"https://clinicaltrials.gov/study/NCT04468061"},"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/nct04468061"}