{"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 randomized 644 patients (323/321) with previously untreated advanced TNBC for whom PD-1/PD-L1 inhibitor therapy was unsuitable. FDA reports median PFS 10.8 versus 5.6 months (HR 0.57, 95% CI 0.47 to 0.69) and OS 23.7 versus 18.7 months (HR 0.79, 95% CI 0.64 to 0.98). FDA approved the advanced-disease indication May 22, 2026. These outcomes do not establish postoperative benefit or provide a head-to-head comparison against sacituzumab govitecan.","status":"positive","asOf":"2026-10-06","links":[{"label":"FDA approval and randomized efficacy results","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer"},{"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","participation":[{"nct":"NCT05374512","source":"https://clinicaltrials.gov/study/NCT05374512","fetchedAt":"2026-10-07T16:53:41.225Z","studySha256":"deee167cb902a6c7629a2cd0d9c2301a71964501861e4287d5e1fd69b17e37cc","overallStatus":"ACTIVE_NOT_RECRUITING","lastUpdatePosted":"2026-05-15","leadSponsor":"AstraZeneca","collaboratorCount":1,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":644,"enrolmentType":"ACTUAL","siteCount":228,"recruitingSiteCount":0,"countries":["Argentina","Belgium","Brazil","Canada","China","France","Germany","Hungary","India","Italy","Japan","Mexico","Philippines","Poland","Singapore","South Africa","South Korea","Spain","Taiwan","Thailand","Turkey (Türkiye)","United Kingdom","United States"]}],"result":"TROPION-Breast02 randomized 644 patients (323/321) with previously untreated advanced TNBC for whom PD-1/PD-L1 inhibitor therapy was unsuitable. FDA reports median PFS 10.8 versus 5.6 months (HR 0.57, 95% CI 0.47 to 0.69) and OS 23.7 versus 18.7 months (HR 0.79, 95% CI 0.64 to 0.98). FDA approved the advanced-disease indication May 22, 2026. These outcomes do not establish postoperative benefit or provide a head-to-head comparison against sacituzumab govitecan.","started":"2022-05-16","startedType":"actual","yearReported":2025,"enrolled":644,"enrolledBasis":"randomised","enrolledNote":"FDA-reported randomized efficacy population. ClinicalTrials.gov lists 644 participants (actual); registry and FDA populations remain separately attributed.","outcomes":[{"endpoint":"Progression-free survival (BICR)","primary":true,"unit":"months","arms":[{"name":"Datopotamab deruxtecan","n":323,"value":10.8},{"name":"Chemotherapy","n":321,"value":5.6}],"hr":0.57,"ci":[0.47,0.69],"p":"<0.0001","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer"},{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Datopotamab deruxtecan","n":323,"value":23.7},{"name":"Chemotherapy","n":321,"value":18.7}],"hr":0.79,"ci":[0.64,0.98],"p":"0.0290","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer"},{"endpoint":"Confirmed objective response rate (FDA approval analysis)","unit":"%","arms":[{"name":"Datopotamab deruxtecan","value":64,"note":"95% CI 58 to 69"},{"name":"Chemotherapy","value":30,"note":"95% CI 25 to 36"}],"source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer"}],"replication":"FDA-supporting advanced-disease randomized trial; postoperative benefit is not established."},"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/"}],"institution":[{"id":"ucsf","kind":"institution","name":"UCSF Helen Diller Family Comprehensive Cancer Center","route":"/institutions/ucsf/"}]}}