{"entity":{"id":"nct06112379","kind":"trial","name":"A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer","aka":["TROPION-Breast04"],"tldr":"A phase 3 trial of Durvalumab, Pembrolizumab, Doxorubicin, Epirubicin, Cyclophosphamide and Carboplatin in HR-positive / HER2-negative breast cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer. ClinicalTrials.gov record last updated 2026-07-13: active not recruiting. Enrollment is actual at 1902 participants. Primary completion is estimated at 2028-11-20. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications. Registered interventions: Dato-DXd, Durvalumab, Pembrolizumab, Doxorubicin, Epirubicin, Cyclophosphamide, Paclitaxel, Carboplatin, Capecitabine, Olaparib. Registered primary measures: Event-free survival (EFS) in the experimental vs control arms.","status":"active","asOf":"2026-10-06","links":[{"label":"ClinicalTrials.gov NCT06112379","url":"https://clinicaltrials.gov/study/NCT06112379"},{"label":"TROPION-Breast04 design","url":"https://doi.org/10.1177/17588359251316176"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","tnbc","tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["trop2"],"drugs":["durvalumab","pembrolizumab","doxorubicin","epirubicin","cyclophosphamide","carboplatin"],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["ClinicalTrials.gov record last updated 2026-07-13: active not recruiting. Enrollment is actual at 1902 participants. Primary completion is estimated at 2028-11-20. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications.","TROPION-Breast04 (design, Therapeutic Advances in Medical Oncology 2025): neoadjuvant datopotamab deruxtecan with durvalumab then adjuvant durvalumab with or without chemotherapy, against the KEYNOTE-522 regimen, in untreated triple-negative or hormone-receptor-low HER2-negative breast cancer; 1,902 patients randomised (registry actual), primary endpoint event-free survival, primary completion November 2028. UK sites (registry, 7): Birmingham, Cardiff, Lancaster, London, Northampton, Oxford, Taunton."],"nct":"NCT06112379","phase":"3","setting":"A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer","sponsor":"AstraZeneca","participation":[{"nct":"NCT06112379","source":"https://clinicaltrials.gov/study/NCT06112379","fetchedAt":"2026-10-07T16:54:14.819Z","studySha256":"94406f60a7292974b9e1a250e3879c961a0549b410e2059d21909239d1ebd20b","overallStatus":"ACTIVE_NOT_RECRUITING","lastUpdatePosted":"2026-07-13","leadSponsor":"AstraZeneca","collaboratorCount":1,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":1902,"enrolmentType":"ACTUAL","siteCount":283,"recruitingSiteCount":0,"countries":["Australia","Austria","Belgium","Brazil","Bulgaria","Canada","China","France","Germany","Hong Kong","Hungary","India","Italy","Japan","Malaysia","Poland","Singapore","South Korea","Spain","Switzerland","Taiwan","Thailand","Turkey (Türkiye)","United Kingdom","United States","Vietnam"]}],"started":"2023-11-14","startedType":"actual","enrolled":1902,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct06112379/","neighbours":{"cancer":[{"id":"tnbc-early","kind":"cancer","name":"Early triple-negative breast cancer","route":"/cancers/tnbc-early/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"trop2","kind":"target","name":"TROP2","route":"/targets/trop2/"}],"drug":[{"id":"carboplatin","kind":"drug","name":"Carboplatin","route":"/drugs/carboplatin/"},{"id":"cyclophosphamide","kind":"drug","name":"Cyclophosphamide","route":"/drugs/cyclophosphamide/"},{"id":"datopotamab-deruxtecan","kind":"drug","name":"Datopotamab deruxtecan","route":"/drugs/datopotamab-deruxtecan/"},{"id":"doxorubicin","kind":"drug","name":"Doxorubicin","route":"/drugs/doxorubicin/"},{"id":"durvalumab","kind":"drug","name":"Durvalumab","route":"/drugs/durvalumab/"},{"id":"epirubicin","kind":"drug","name":"Epirubicin","route":"/drugs/epirubicin/"},{"id":"olaparib","kind":"drug","name":"Olaparib","route":"/drugs/olaparib/"},{"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":"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/"}]}}