{"entity":{"id":"ascent-05","kind":"trial","name":"ASCENT-05 / OptimICE-RD (AFT-65, GBG 119, NSABP B-63)","aka":[],"tldr":"Tests whether giving a TROP2 ADC after surgery can cure more of the triple-negative patients whose cancer survived pre-surgery chemo-immunotherapy.","summary":"International randomised phase 3 in the highest-risk curable TNBC population: residual disease (non-pCR) after KEYNOTE-522-type neoadjuvant therapy. Primary endpoint invasive disease-free survival. If positive, it would be the first ADC in the curative TNBC setting and the KATHERINE moment for TNBC. Readout is event-driven; our estimate is 2027.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05633654","url":"https://clinicaltrials.gov/study/NCT05633654"},{"label":"OptimICE-RD design (Future Oncology 2024)","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11520537/"},{"label":"OptimICE-RD design (Future Oncology 2024)","url":"https://doi.org/10.1080/14796694.2024.2357534"}],"tags":[],"related":["idea-post-neoadjuvant-adc","tropion-breast03"],"cancers":["tnbc"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["sacituzumab-govitecan","pembrolizumab"],"companies":[],"institutions":[],"pathways":[],"terms":["rcb","pcr","efs"],"trials":["keynote-522"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Design paper (Future Oncology 2024): AFT-65/ASCENT-05/OptimICE-RD randomises patients with residual invasive disease after neoadjuvant therapy to sacituzumab govitecan with pembrolizumab or physician's choice of pembrolizumab with or without capecitabine; primary endpoint invasive disease-free survival; registry enrolment 1,514 estimated, primary completion June 2027. UK sites (registry, 10): Hull, University Hospitals Birmingham, Clatterbridge Liverpool, Barts, Guy's, Royal Marsden, the Christie, East and North Hertfordshire (Mount Vernon), Taunton, York.","Registry status on 24 September 2026: Recruiting (registry record last updated 9 September 2026; primary completion expected June 2027)."],"nct":"NCT05633654","phase":"3","setting":"Stage II to III TNBC with residual invasive disease after neoadjuvant therapy and surgery: adjuvant sacituzumab govitecan + pembrolizumab vs pembrolizumab ± capecitabine","sponsor":"Gilead / Alliance Foundation Trials","started":"2022-12-12","startedType":"actual","enrolled":1514,"enrolledBasis":"registry","outcomes":[],"replication":"Ongoing; no results."},"route":"/trials/ascent-05/","neighbours":{"idea":[{"id":"idea-post-neoadjuvant-adc","kind":"idea","name":"ADC for residual disease after KEYNOTE-522","route":"/ideas/idea-post-neoadjuvant-adc/"},{"id":"idea-tnbc-ctdna-guided-adjuvant-decisions","kind":"idea","name":"ctDNA-guided adjuvant decisions after residual disease: escalate the positive, spare the negative","route":"/ideas/idea-tnbc-ctdna-guided-adjuvant-decisions/"}],"trial":[{"id":"create-x","kind":"trial","name":"CREATE-X","route":"/trials/create-x/"},{"id":"keynote-522","kind":"trial","name":"KEYNOTE-522","route":"/trials/keynote-522/"},{"id":"tropion-breast03","kind":"trial","name":"TROPION-Breast03","route":"/trials/tropion-breast03/"}],"cancer":[{"id":"tnbc-early","kind":"cancer","name":"Early triple-negative breast cancer","route":"/cancers/tnbc-early/"},{"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":"capecitabine","kind":"drug","name":"Capecitabine","route":"/drugs/capecitabine/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"},{"id":"sacituzumab-govitecan","kind":"drug","name":"Sacituzumab govitecan","route":"/drugs/sacituzumab-govitecan/"}],"term":[{"id":"efs","kind":"term","name":"Event-free / disease-free survival (EFS, DFS, iDFS, RFS)","route":"/terms/efs/"},{"id":"pcr","kind":"term","name":"Pathologic complete response (pCR)","route":"/terms/pcr/"},{"id":"rcb","kind":"term","name":"Residual cancer burden (RCB)","route":"/terms/rcb/"},{"id":"tnbc-residual-disease-decision","kind":"term","name":"Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point","route":"/terms/tnbc-residual-disease-decision/"},{"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/"}],"paper":[{"id":"paper-symmans-rcb-long-term-prognosis-subtype-jco-2017","kind":"paper","name":"Long-Term Prognostic Risk After Neoadjuvant Chemotherapy Associated With Residual Cancer Burden and Breast Cancer Subtype","route":"/key-papers/paper-symmans-rcb-long-term-prognosis-subtype-jco-2017/"}],"roadmap":[{"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/"}]}}