{"entity":{"id":"tropion-breast03","kind":"trial","name":"TROPION-Breast03","aka":[],"tldr":"Tests whether an experimental drug, with or without immunotherapy, helps prevent recurrence after residual triple-negative breast cancer is removed at surgery.","summary":"TROPION-Breast03 compares datopotamab deruxtecan plus durvalumab, datopotamab deruxtecan alone, and investigator choice of capecitabine, pembrolizumab or both after surgery for stage I to III TNBC with residual invasive disease following neoadjuvant treatment. The registered primary iDFS comparison is the datopotamab deruxtecan plus durvalumab arm against investigator choice. ClinicalTrials.gov record last updated 2026-06-15: active not recruiting. Enrollment is actual at 1174 participants. Primary completion is estimated at 2027-09-20. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications.","status":"active","asOf":"2026-10-06","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":["trop2"],"drugs":["datopotamab-deruxtecan","durvalumab","pembrolizumab"],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":["rcb","efs"],"trials":["keynote-522"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["ClinicalTrials.gov record last updated 2026-06-15: active not recruiting. Enrollment is actual at 1174 participants. Primary completion is estimated at 2027-09-20. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications.","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":"A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)","sponsor":"AstraZeneca / Daiichi Sankyo","participation":[{"nct":"NCT05629585","source":"https://clinicaltrials.gov/study/NCT05629585","fetchedAt":"2026-10-07T16:53:48.601Z","studySha256":"2b285eaf40cb16c57950e61274340f7d2e25f91d5f9e53d62744d30a29ce4646","overallStatus":"ACTIVE_NOT_RECRUITING","lastUpdatePosted":"2026-06-15","leadSponsor":"AstraZeneca","collaboratorCount":2,"minimumAge":"18 Years","maximumAge":"130 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":1174,"enrolmentType":"ACTUAL","siteCount":276,"recruitingSiteCount":0,"countries":["Belgium","Brazil","Canada","China","Denmark","France","Germany","Greece","Italy","Japan","Puerto Rico","South Korea","Spain","Sweden","Taiwan","United Kingdom","United States"]}],"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/"}],"target":[{"id":"trop2","kind":"target","name":"TROP2","route":"/targets/trop2/"}],"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/"}]}}