{"entity":{"id":"tropion-breast03","kind":"trial","name":"TROPION-Breast03","aka":[],"tldr":"TROPION-Breast03 is the Dato-DXd counterpart to ASCENT-05: an ADC, with or without immunotherapy, for triple-negative patients with leftover cancer at surgery.","summary":"TROPION-Breast03, trial NCT05629585 sponsored by AstraZeneca and Daiichi Sankyo, is the datopotamab deruxtecan counterpart to ASCENT-05: an antibody-drug conjugate, with or without immunotherapy, for patients with stage I to III triple-negative breast cancer left with residual invasive disease after neoadjuvant therapy. It is a three-arm phase 3 of 1,075 patients randomised two to one to two to datopotamab deruxtecan for eight cycles plus durvalumab for nine, datopotamab deruxtecan alone, or investigator's choice of capecitabine, pembrolizumab or both, with invasive disease-free survival as the primary endpoint and estimated primary completion on 20 September 2027. It is ongoing with no results, and whether an ADC after residual disease improves on the KATHERINE-style switch strategy in TNBC is the question it will answer.","status":"active","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT05629585","url":"https://clinicaltrials.gov/study/NCT05629585"},{"label":"TROPION-Breast03 design (Ther Adv Med Oncol 2024)","url":"https://journals.sagepub.com/doi/10.1177/17588359241248336"},{"label":"TROPION-Breast03 design","url":"https://doi.org/10.1177/17588359241248336"}],"tags":[],"related":["idea-post-neoadjuvant-adc","ascent-05"],"cancers":["tnbc"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["datopotamab-deruxtecan","durvalumab","pembrolizumab"],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":["rcb","efs"],"trials":["keynote-522"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Design paper (Therapeutic Advances in Medical Oncology 2024): stage I to III triple-negative disease with residual invasive disease at surgery, randomised 2 to 1 to 2 to datopotamab deruxtecan 6 mg/kg for eight cycles with durvalumab for nine, datopotamab alone, or investigator's choice of capecitabine, pembrolizumab or both; primary endpoint invasive disease-free survival for the combination against investigator's choice; registry 1,174 actual, primary completion September 2027. UK sites (registry, 12): Cambridge, Cardiff, Edinburgh, Greater London, London (2), Londonderry, Manchester, Newcastle upon Tyne, Portsmouth, Surrey, Taunton. NICE appraisal GID-TA11835 awaiting development."],"nct":"NCT05629585","phase":"3","setting":"Stage I to III TNBC with residual invasive disease after neoadjuvant therapy: adjuvant Dato-DXd ± durvalumab vs investigator's choice (capecitabine, pembrolizumab, or both)","sponsor":"AstraZeneca / Daiichi Sankyo","started":"2022-11-28","startedType":"actual","enrolled":1174,"enrolledBasis":"registry","outcomes":[],"replication":"Ongoing; no results."},"route":"/trials/tropion-breast03/","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":"ascent-05","kind":"trial","name":"ASCENT-05 / OptimICE-RD (AFT-65, GBG 119, NSABP B-63)","route":"/trials/ascent-05/"},{"id":"create-x","kind":"trial","name":"CREATE-X","route":"/trials/create-x/"},{"id":"keynote-522","kind":"trial","name":"KEYNOTE-522","route":"/trials/keynote-522/"}],"cancer":[{"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":"datopotamab-deruxtecan","kind":"drug","name":"Datopotamab deruxtecan","route":"/drugs/datopotamab-deruxtecan/"},{"id":"durvalumab","kind":"drug","name":"Durvalumab","route":"/drugs/durvalumab/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"},{"id":"daiichi-sankyo","kind":"company","name":"Daiichi Sankyo","route":"/companies/daiichi-sankyo/"}],"term":[{"id":"efs","kind":"term","name":"Event-free / disease-free survival (EFS, DFS, iDFS, RFS)","route":"/terms/efs/"},{"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/"}]}}