{"entity":{"id":"tropion-breast02","kind":"trial","name":"TROPION-Breast02","aka":[],"tldr":"The first trial to show an overall survival benefit for a first-line ADC in triple-negative breast cancer.","summary":"TROPION-Breast02, trial NCT05374512 sponsored by AstraZeneca and Daiichi Sankyo and reported at ESMO 2025 and ESMO Breast 2026, was the first trial to show an overall survival benefit for a first-line antibody-drug conjugate in metastatic triple-negative breast cancer, in patients who cannot receive PD-1 or PD-L1 inhibitors. It randomised 644 patients to datopotamab deruxtecan or chemotherapy, met both dual primary endpoints of progression-free and overall survival, and led to FDA approval in the second quarter of 2026. OnCo links it to triple-negative breast cancer, datopotamab deruxtecan, Rebecca Dent, the TNBC and TROP2 ADC roadmaps and the TROPION-Breast01 paper. The comparison with sacituzumab is indirect, so choice depends on side-effect profiles, stomatitis and eye effects against neutropenia and diarrhoea, which is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT05374512","url":"https://clinicaltrials.gov/study/NCT05374512"},{"label":"LBBC ASCO 2026 summary","url":"https://www.lbbc.org/news/pivotal-progress-in-tnbc-asco-2026"},{"label":"TROPION-Breast02 (Annals of Oncology 2026)","url":"https://doi.org/10.1016/j.annonc.2026.03.008"},{"label":"Datroway label (openFDA): TROPION-Breast02 study section","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22DATROWAY%22"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["datopotamab-deruxtecan"],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["rebecca-dent"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Primary paper (Annals of Oncology 2026): 644 patients randomised 1 to 1 between May 2022 and June 2024, 90 percent PD-L1-negative, 10 percent with stable brain metastases; progression-free survival 10.8 versus 5.6 months (hazard ratio 0.57), overall survival 23.7 versus 18.7 months (hazard ratio 0.79, p 0.029); treatment-related grade 3 or higher adverse events 33 versus 29 percent, no treatment-related deaths. The chemotherapy arm was nab-paclitaxel 54 percent, paclitaxel 28 percent, eribulin 11 percent, carboplatin 4.7 percent, capecitabine 2.2 percent (Datroway label). UK sites (registry, 9): Bristol, Cardiff, Edinburgh, London (3), Northampton, Nottingham, Warwick. NICE appraisal GID-TA11535 awaiting development; no EU triple-negative indication yet."],"nct":"NCT05374512","phase":"3","setting":"First-line metastatic TNBC, not candidates for PD-1/PD-L1: Dato-DXd vs chemotherapy","sponsor":"AstraZeneca / Daiichi Sankyo","result":"OS 23.7 vs 18.7 months; PFS also improved.","started":"2022-05-16","startedType":"actual","yearReported":2025,"enrolled":644,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (BICR)","primary":true,"unit":"months","arms":[{"name":"Datopotamab deruxtecan","n":323,"value":10.8},{"name":"Chemotherapy (ICC)","n":321,"value":5.6}],"hr":0.57,"ci":[0.47,0.69],"p":"<0.0001","source":"https://www.annalsofoncology.org/article/S0923-7534(26)00130-4/fulltext"},{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Datopotamab deruxtecan","value":23.7},{"name":"Chemotherapy (ICC)","value":18.7}],"hr":0.79,"ci":[0.64,0.98],"p":"0.0291","source":"https://www.astrazeneca.com/media-centre/press-releases/2025/datroway-demonstrated-an-unprecedented-median-overall-survival-improvement-of-five-months-vs-chemotherapy-as-1st-line-treatment-for-patients-with-metastatic-triple-negative-breast-cancer-for-whom-immunotherapy-was-not-an-option-in-tropion-breast02.html"}],"replication":"Consistent with ASCENT-03 (sacituzumab govitecan, same population, PFS HR 0.62), supporting a TROP2-ADC class effect in first-line PD-1-ineligible TNBC."},"route":"/trials/tropion-breast02/","neighbours":{"cancer":[{"id":"her2-low-metastatic-breast-cancer","kind":"cancer","name":"HER2-low and HER2-ultralow metastatic breast cancer","route":"/cancers/her2-low-metastatic-breast-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/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"},{"id":"daiichi-sankyo","kind":"company","name":"Daiichi Sankyo","route":"/companies/daiichi-sankyo/"}],"person":[{"id":"rebecca-dent","kind":"person","name":"Rebecca Dent","route":"/people/rebecca-dent/"}],"paper":[{"id":"paper-nccn-breast-cancer-v4-2026-jnccn-2026","kind":"paper","name":"Breast Cancer, Version 4.2026, NCCN Clinical Practice Guidelines In Oncology","route":"/key-papers/paper-nccn-breast-cancer-v4-2026-jnccn-2026/"},{"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/"},{"id":"paper-tropion-breast01-jco-2024","kind":"paper","name":"TROPION-Breast01: datopotamab deruxtecan versus chemotherapy in pretreated hormone-receptor-positive breast cancer, and why a PFS win did not translate to survival","route":"/key-papers/paper-tropion-breast01-jco-2024/"}],"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-adc-sequencing-trial","kind":"idea","name":"A randomised trial of antibody-drug conjugate sequence in metastatic triple-negative breast cancer","route":"/ideas/idea-tnbc-adc-sequencing-trial/"},{"id":"idea-trop2-pet-selection","kind":"idea","name":"TROP2 PET to choose and sequence TROP2 ADCs","route":"/ideas/idea-trop2-pet-selection/"}],"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/"}]}}