{"preliminary_commentary":{"by_channel":{"x_thread":3},"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,"drugs_tested":null,"indication":null,"name":"NCT05633654","nct_id":"NCT05633654","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct05633654. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","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 SG 10 mg/kg intravenously on Days 1 and 8 of 21-day cycles and pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles.\n\nTreatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death.","label":"Sacituzumab govitecan-hziy (SG) + Pembrolizumab","type":"EXPERIMENTAL"},{"description":"Participants will receive one of the following TPC regimens determined prior to randomization:\n\n* Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles OR\n* Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles and capecitabine 1000 mg/m\\^2 orally twice daily on Days 1 through 14 of 21-day cycles for 8 cycles.\n\nTreatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death.","label":"Treatment of Physician's Choice (TPC): Pembrolizumab or Pembrolizumab + Capecitabine","type":"ACTIVE_COMPARATOR"}],"collaborators":["Alliance Foundation Trials, LLC.","NSABP Foundation Inc","GBG Forschungs GmbH"],"completion_date":{"date":"2031-08","type":"ESTIMATED"},"conditions":["Triple Negative Breast Cancer"],"enrollment":{"count":1514,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Sacituzumab govitecan-hziy (SG)","otherNames":["GS-0132","IMMU-132","Trodelvy™"],"type":"DRUG"},{"name":"Pembrolizumab","otherNames":["KEYTRUDA®"],"type":"DRUG"},{"name":"Capecitabine","otherNames":["Xeloda"],"type":"DRUG"}],"last_update":"2026-11-04","lead_sponsor":"Gilead Sciences","official_title":"A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy","overall_status":"RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2027-06","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Invasive Disease-free Survival (iDFS)","timeFrame":"Up to 60 months"}],"references":[{"citation":"Tolaney SM, DeMichele A, Takano T, Rugo HS, Perou C, Lynce F, Parsons HA, Santa-Maria CA, Rocque GB, Yao W, Sun SW, Mocci S, Partridge AH, Carey LA. OptimICE-RD: sacituzumab govitecan + pembrolizumab vs pembrolizumab (+/- capecitabine) for residual triple-negative breast cancer. Future Oncol. 2024;20(31):2343-2355. doi: 10.1080/14796694.2024.2357534. Epub 2024 Jun 26.","pmid":"38922307","type":"DERIVED"}],"start_date":{"date":"2022-12-12","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)","url":"https://clinicaltrials.gov/study/NCT05633654"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct05633654"}