{"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 compares datopotamab deruxtecan with or without durvalumab against chemotherapy plus pembrolizumab in previously untreated PD-L1-positive advanced TNBC. The primary PFS comparison is datopotamab deruxtecan plus durvalumab against chemotherapy plus pembrolizumab. ClinicalTrials.gov record last updated 2026-09-25: recruiting. Enrollment is planned at 625 participants. Primary completion is estimated at 2027-07-28. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications.","status":"recruiting","asOf":"2026-10-06","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":["trop2"],"drugs":["datopotamab-deruxtecan","durvalumab","pembrolizumab"],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["ClinicalTrials.gov record last updated 2026-09-25: recruiting. Enrollment is planned at 625 participants. Primary completion is estimated at 2027-07-28. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications.","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":"A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)","sponsor":"AstraZeneca / Daiichi Sankyo","participation":[{"nct":"NCT06103864","source":"https://clinicaltrials.gov/study/NCT06103864","fetchedAt":"2026-10-07T16:54:11.803Z","studySha256":"f5918ab22c9442b9e27be57f72096b83ea38c923a9b281f6e0f95f26fc65d5d8","overallStatus":"RECRUITING","lastUpdatePosted":"2026-09-25","leadSponsor":"AstraZeneca","collaboratorCount":1,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":625,"enrolmentType":"ESTIMATED","siteCount":318,"recruitingSiteCount":242,"countries":["Argentina","Australia","Brazil","Canada","China","France","Germany","Hong Kong","India","Italy","Japan","Mexico","Philippines","Poland","Singapore","South Africa","South Korea","Spain","Taiwan","Thailand","Turkey (Türkiye)","United Kingdom","United States","Vietnam"]}],"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/"}],"target":[{"id":"trop2","kind":"target","name":"TROP2","route":"/targets/trop2/"}],"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/"}]}}