{"entity":{"id":"destiny-breast11","kind":"trial","name":"DESTINY-Breast11","aka":[],"tldr":"DESTINY-Breast11 brought Enhertu into pre-surgery treatment of HER2-positive breast cancer, replacing anthracyclines.","summary":"DESTINY-Breast11, trial NCT05113251 sponsored by Daiichi Sankyo and AstraZeneca and reported in 2025, brought trastuzumab deruxtecan into pre-surgery treatment of high-risk HER2-positive early breast cancer, replacing anthracyclines. It randomised 927 patients to trastuzumab deruxtecan followed by a taxane, trastuzumab and pertuzumab, or dose-dense anthracycline chemotherapy followed by the same, met its primary pathologic complete response endpoint with a better tolerated regimen, and led to FDA approval in the second quarter of 2026 alongside DESTINY-Breast05, while the trastuzumab deruxtecan monotherapy arm was stopped early for lower efficacy and event-free survival remains immature. Whether a higher pathologic complete response rate converts into fewer recurrences is the open question.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT05113251","url":"https://clinicaltrials.gov/study/NCT05113251"}],"tags":[],"related":[],"cancers":["breast-her2-positive","her2-positive-early-breast-cancer"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["trastuzumab-deruxtecan"],"companies":["daiichi-sankyo","astrazeneca"],"institutions":[],"pathways":[],"terms":["pcr"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05113251","phase":"3","setting":"Neoadjuvant high-risk HER2+ early breast cancer: T-DXd followed by THP vs ddAC-THP","sponsor":"Daiichi Sankyo / AstraZeneca","result":"pCR 67.3% vs 56.3%.","started":"2021-10-25","startedType":"actual","yearReported":2025,"enrolled":927,"enrolledBasis":"registry","outcomes":[{"endpoint":"Pathologic complete response (ypT0/Tis ypN0)","primary":true,"unit":"%","arms":[{"name":"T-DXd → THP","n":321,"value":67.3},{"name":"ddAC → THP","n":320,"value":56.3}],"p":"0.003","source":"https://web.archive.org/web/20231201043719/https://www.esmo.org/newsroom/press-releases"},{"endpoint":"Event-free survival","unit":"months","arms":[{"name":"T-DXd → THP","note":"Immature; the T-DXd monotherapy arm was stopped early for lower efficacy."},{"name":"ddAC → THP"}]}],"replication":"Single pivotal neoadjuvant trial; pCR is a surrogate. The post-neoadjuvant DESTINY-Breast05 (T-DXd vs T-DM1) is the companion evidence in early HER2+ disease."},"route":"/trials/destiny-breast11/","neighbours":{"cancer":[{"id":"her2-positive-early-breast-cancer","kind":"cancer","name":"Early HER2-positive breast cancer","route":"/cancers/her2-positive-early-breast-cancer/"},{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"}],"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":"trastuzumab-deruxtecan","kind":"drug","name":"Trastuzumab deruxtecan","route":"/drugs/trastuzumab-deruxtecan/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"},{"id":"daiichi-sankyo","kind":"company","name":"Daiichi Sankyo","route":"/companies/daiichi-sankyo/"}],"term":[{"id":"pcr","kind":"term","name":"Pathologic complete response (pCR)","route":"/terms/pcr/"}],"idea":[{"id":"idea-tdxd-first-then-nothing","kind":"idea","name":"Can T-DXd alone cure early HER2-positive disease?","route":"/ideas/idea-tdxd-first-then-nothing/"}],"paper":[{"id":"paper-katherine-nejm-2019","kind":"paper","name":"KATHERINE: switching to T-DM1 when HER2-positive breast cancer survives pre-surgery treatment","route":"/key-papers/paper-katherine-nejm-2019/"}],"roadmap":[{"id":"surgery-roadmap","kind":"roadmap","name":"Surgery roadmap: radical operations → less surgery → no surgery when a drug has done the work","route":"/roadmaps/surgery-roadmap/"}]}}