{"entity":{"id":"tropion-breast05","kind":"trial","name":"TROPION-Breast05","aka":[],"tldr":"Tests whether Dato-DXd plus a PD-L1 blocker beats today's immunotherapy-chemotherapy standard.","summary":"TROPION-Breast05, trial NCT06103864 sponsored by AstraZeneca and Daiichi Sankyo, tests whether datopotamab deruxtecan with or without the PD-L1 antibody durvalumab beats today's pembrolizumab plus chemotherapy standard in first-line PD-L1-positive metastatic triple-negative breast cancer. It is a three-arm phase 3 of 625 patients with readout expected in 2026 to 2027, and together with ASCENT-04 it will define ADC plus immunotherapy as first-line therapy. OnCo links it to triple-negative breast cancer, datopotamab deruxtecan, durvalumab, pembrolizumab, the ADC plus checkpoint inhibitor pairing and the TNBC and TROP2 ADC roadmaps. It is ongoing with no results, and whether the ADC alone is enough or immunotherapy must be added is the question its three-arm design will answer.","status":"recruiting","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT06103864","url":"https://clinicaltrials.gov/study/NCT06103864"},{"label":"TROPION-Breast05 design","url":"https://doi.org/10.1177/17588359251327992"}],"tags":[],"related":[],"cancers":["tnbc"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["datopotamab-deruxtecan","durvalumab","pembrolizumab"],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Design paper (Therapeutic Advances in Medical Oncology 2025): 625 patients with PD-L1-high (CPS 10 or more) disease randomised 1 to 1 to datopotamab deruxtecan 6 mg/kg with durvalumab 1,120 mg every 3 weeks or investigator's choice chemotherapy with pembrolizumab, with a third datopotamab-alone arm in selected countries; primary endpoint progression-free survival by blinded review; primary completion July 2027. UK sites (registry, 10): Cardiff, Chelsea, Leicester, Liverpool, London (2), Oxford, Surrey, Sutton, Taunton."],"nct":"NCT06103864","phase":"3","setting":"First-line PD-L1+ metastatic TNBC: Dato-DXd ± durvalumab vs pembrolizumab + chemotherapy","sponsor":"AstraZeneca / Daiichi Sankyo","started":"2023-11-23","startedType":"actual","enrolled":625,"enrolledBasis":"registry","outcomes":[],"replication":"Ongoing; no results."},"route":"/trials/tropion-breast05/","neighbours":{"cancer":[{"id":"tnbc-metastatic","kind":"cancer","name":"Metastatic triple-negative breast cancer","route":"/cancers/tnbc-metastatic/"},{"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":"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/"}],"paper":[{"id":"paper-tropion-breast02-ann-oncol-2026","kind":"paper","name":"Datopotamab deruxtecan in patients with untreated, advanced triple-negative breast cancer (TROPION-Breast02): a randomised, open-label, international, phase III trial","route":"/key-papers/paper-tropion-breast02-ann-oncol-2026/"}],"roadmap":[{"id":"tnbc-history","kind":"roadmap","name":"TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line","route":"/roadmaps/tnbc-history/"},{"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/"},{"id":"trop2-adc-roadmap","kind":"roadmap","name":"TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET","route":"/roadmaps/trop2-adc-roadmap/"}],"idea":[{"id":"idea-tnbc-brain-metastasis-trials","kind":"idea","name":"Trials that include, and report, brain metastases in triple-negative breast cancer","route":"/ideas/idea-tnbc-brain-metastasis-trials/"}],"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/"}],"trial":[{"id":"diamond","kind":"trial","name":"DIAMOND","route":"/trials/diamond/"},{"id":"keynote-355","kind":"trial","name":"KEYNOTE-355","route":"/trials/keynote-355/"}],"pairing":[{"id":"adc-plus-io","kind":"pairing","name":"ADC + checkpoint inhibitor","route":"/pairings/adc-plus-io/"}]}}