{"entity":{"id":"ascent-03","kind":"trial","name":"ASCENT-03","aka":[],"tldr":"Moved Trodelvy into first-line use for triple-negative patients who cannot receive immunotherapy.","summary":"FDA reports 558 randomized patients with previously untreated unresectable locally advanced or metastatic TNBC who were not candidates for PD-1/PD-L1 therapy. Sacituzumab govitecan versus chemotherapy improved median PFS, 9.7 versus 6.9 months (HR 0.62, 95% CI 0.50 to 0.77). Overall survival was immature at approval. ClinicalTrials.gov lists 623 actual participants; the difference from the FDA efficacy-study population is retained without inventing a reconciliation. These are advanced-disease outcomes, not postoperative recurrence prevention.","status":"positive","asOf":"2026-10-06","links":[{"label":"FDA approval and randomized efficacy results","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line"},{"label":"ASCENT-03 (NEJM 2025)","url":"https://doi.org/10.1056/NEJMoa2511734"},{"label":"Trodelvy label (openFDA): ASCENT-03 study section","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22TRODELVY%22"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-govitecan"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-ascent-03-n-engl-j-med-2025"],"journals":[],"dependsOn":[],"notes":["Primary paper (NEJM 2025): 558 patients not candidates for PD-1 or PD-L1 inhibitors (99.5 percent CPS below 10) randomised 1 to 1; progression-free survival 9.7 versus 6.9 months (hazard ratio 0.62), confirmed response 48 versus 46 percent with a median duration of 12.2 versus 7.2 months; grade 3 or higher adverse events 66 versus 62 percent, discontinuation 4 versus 12 percent; 51 percent of patients had died at the label's data cut with overall survival immature. UK sites (registry, 3): Leeds Teaching Hospitals, Barts Health, University College London Hospitals. NICE appraisal GID-TA11489 awaiting development; EU indication listed in September 2026."],"nct":"NCT05382299","phase":"3","setting":"First-line metastatic TNBC, not candidates for PD-1 inhibitors: sacituzumab govitecan vs chemotherapy","sponsor":"Gilead","participation":[{"nct":"NCT05382299","source":"https://clinicaltrials.gov/study/NCT05382299","fetchedAt":"2026-10-07T16:53:41.225Z","studySha256":"289f3d113452cd4082a69cab3194eb32635c4a81855161b0b559f2449525e1af","overallStatus":"ACTIVE_NOT_RECRUITING","lastUpdatePosted":"2026-04-06","leadSponsor":"Gilead Sciences","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":623,"enrolmentType":"ACTUAL","siteCount":363,"recruitingSiteCount":0,"countries":["Argentina","Australia","Austria","Belgium","Brazil","Canada","Chile","China","Czechia","France","Germany","Hong Kong","Hungary","Israel","Italy","Japan","Malaysia","Mexico","Netherlands","Poland","Romania","Slovakia","South Africa","South Korea","Spain","Switzerland","Taiwan","Turkey (Türkiye)","United Kingdom","United States"]}],"result":"FDA reports 558 randomized patients with previously untreated unresectable locally advanced or metastatic TNBC who were not candidates for PD-1/PD-L1 therapy. Sacituzumab govitecan versus chemotherapy improved median PFS, 9.7 versus 6.9 months (HR 0.62, 95% CI 0.50 to 0.77). Overall survival was immature at approval. ClinicalTrials.gov lists 623 actual participants; the difference from the FDA efficacy-study population is retained without inventing a reconciliation. These are advanced-disease outcomes, not postoperative recurrence prevention.","started":"2022-07-20","startedType":"actual","yearReported":2025,"enrolled":558,"enrolledBasis":"randomised","enrolledNote":"FDA efficacy-study population is 558 randomized; ClinicalTrials.gov reports 623 actual participants. The difference has not been reconciled from a full patient-flow review.","outcomes":[{"endpoint":"Progression-free survival (BICR)","primary":true,"unit":"months","arms":[{"name":"Sacituzumab govitecan","value":9.7},{"name":"Chemotherapy","value":6.9}],"hr":0.62,"ci":[0.5,0.77],"p":"<0.0001","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line"},{"endpoint":"Overall survival","unit":"months","arms":[{"name":"Sacituzumab govitecan","note":"Immature at FDA approval on June 24, 2026."},{"name":"Chemotherapy"}],"source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line"},{"endpoint":"Confirmed objective response rate (FDA approval analysis)","unit":"%","arms":[{"name":"Sacituzumab govitecan","value":50,"note":"95% CI 44 to 56"},{"name":"Chemotherapy","value":47,"note":"95% CI 41 to 53"}],"source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line"}],"replication":"FDA-supporting advanced-disease randomized trial; postoperative benefit is not established."},"route":"/trials/ascent-03/","neighbours":{"cancer":[{"id":"tnbc-metastatic","kind":"cancer","name":"Metastatic triple-negative breast cancer","route":"/cancers/tnbc-metastatic/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"},{"id":"topoisomerase-inhibitors","kind":"technology","name":"Topoisomerase-I inhibitors (and ADC payloads)","route":"/technologies/topoisomerase-inhibitors/"}],"drug":[{"id":"sacituzumab-govitecan","kind":"drug","name":"Sacituzumab govitecan","route":"/drugs/sacituzumab-govitecan/"}],"company":[{"id":"gilead","kind":"company","name":"Gilead Sciences (incl. Kite)","route":"/companies/gilead/"}],"paper":[{"id":"paper-ascent-nejm-2021","kind":"paper","name":"ASCENT: sacituzumab govitecan doubles survival in heavily pretreated metastatic triple-negative breast cancer","route":"/key-papers/paper-ascent-nejm-2021/"},{"id":"paper-nccn-breast-cancer-v4-2026-jnccn-2026","kind":"paper","name":"Breast Cancer, Version 4.2026, NCCN Clinical Practice Guidelines In Oncology","route":"/key-papers/paper-nccn-breast-cancer-v4-2026-jnccn-2026/"},{"id":"paper-tropion-breast02-ann-oncol-2026","kind":"paper","name":"Datopotamab deruxtecan in patients with untreated, advanced triple-negative breast cancer (TROPION-Breast02): a randomised, open-label, international, phase III trial","route":"/key-papers/paper-tropion-breast02-ann-oncol-2026/"},{"id":"paper-ascent-03-n-engl-j-med-2025","kind":"paper","name":"Sacituzumab Govitecan in Untreated, Advanced Triple-Negative Breast Cancer","route":"/key-papers/paper-ascent-03-n-engl-j-med-2025/"}],"roadmap":[{"id":"tnbc-history","kind":"roadmap","name":"TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line","route":"/roadmaps/tnbc-history/"},{"id":"tnbc-roadmap","kind":"roadmap","name":"Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem","route":"/roadmaps/tnbc-roadmap/"},{"id":"trop2-adc-roadmap","kind":"roadmap","name":"TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET","route":"/roadmaps/trop2-adc-roadmap/"}],"idea":[{"id":"idea-tnbc-adc-sequencing-trial","kind":"idea","name":"A randomised trial of antibody-drug conjugate sequence in metastatic triple-negative breast cancer","route":"/ideas/idea-tnbc-adc-sequencing-trial/"},{"id":"idea-trop2-pet-selection","kind":"idea","name":"TROP2 PET to choose and sequence TROP2 ADCs","route":"/ideas/idea-trop2-pet-selection/"}],"term":[{"id":"tnbc-trials-open-today","kind":"term","name":"Triple-negative breast cancer trials open today (registry snapshot and UK sites)","route":"/terms/tnbc-trials-open-today/"}],"trial":[{"id":"ascent","kind":"trial","name":"ASCENT","route":"/trials/ascent/"}]}}