{"entity":{"id":"tuxedo-1","kind":"trial","name":"TUXEDO-1","aka":[],"tldr":"TUXEDO-1 was a small study that showed trastuzumab deruxtecan shrinks brain metastases in most people with HER2-positive breast cancer, overturning the assumption that large antibody-drug conjugates cannot work inside the brain.","summary":"TUXEDO-1 was a single-centre phase 2 study in Vienna of trastuzumab deruxtecan in 15 patients with HER2-positive breast cancer and active brain metastases, either untreated or progressing after local therapy, who did not need immediate local treatment. The primary endpoint was intracranial response rate.\n\nMost patients had an intracranial response and the responses were durable, with quality of life maintained. Together with the DEBBRAH study and the brain metastasis cohorts of the DESTINY-Breast trials, it established that trastuzumab deruxtecan is active in the brain and made systemic therapy a realistic option for some patients who would otherwise have had radiotherapy first.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT04752059","url":"https://clinicaltrials.gov/study/NCT04752059"}],"tags":["subtype-trials"],"related":[],"cancers":["her2-positive-breast-brain-metastases","breast-her2-positive","breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["trastuzumab-deruxtecan"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["rupert-bartsch"],"bottlenecks":[],"keyPapers":["paper-tuxedo-1-trastuzumab-deruxtecan-brain-metastases-nat-med-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04752059","phase":"2","setting":"HER2-positive breast cancer with newly diagnosed or progressing brain metastases: single-arm trastuzumab deruxtecan","sponsor":"Medical University of Vienna","result":"Intracranial responses in most patients with active HER2-positive breast cancer brain metastases.","yearReported":2022,"enrolled":15,"outcomes":[]},"route":"/trials/tuxedo-1/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"},{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"},{"id":"her2-positive-breast-brain-metastases","kind":"cancer","name":"HER2-positive breast cancer with brain metastases","route":"/cancers/her2-positive-breast-brain-metastases/"}],"drug":[{"id":"trastuzumab-deruxtecan","kind":"drug","name":"Trastuzumab deruxtecan","route":"/drugs/trastuzumab-deruxtecan/"}],"person":[{"id":"rupert-bartsch","kind":"person","name":"Rupert Bartsch","route":"/people/rupert-bartsch/"}],"paper":[{"id":"paper-tuxedo-1-trastuzumab-deruxtecan-brain-metastases-nat-med-2022","kind":"paper","name":"TUXEDO-1: trastuzumab deruxtecan in HER2-positive breast cancer with active brain metastases","route":"/key-papers/paper-tuxedo-1-trastuzumab-deruxtecan-brain-metastases-nat-med-2022/"}]}}