{"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 is a phase 3 interventional study registered as NCT06112379 by AstraZeneca, with 1902 participants enrolled, started 2023-11-14 and due to reach its primary completion in 2028-11-20. Interventions recorded: Dato-DXd, Durvalumab, Pembrolizumab, Doxorubicin, Epirubicin and Cyclophosphamide.","status":"active","asOf":"2026-09-16","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":[],"drugs":["durvalumab","pembrolizumab","doxorubicin","epirubicin","cyclophosphamide","carboplatin"],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["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, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)","sponsor":"AstraZeneca","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/"}],"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/"}]}}