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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.
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.
Most 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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
15 enrolled.
95% CI 48.1 to 89.1; Simon two-stage null hypothesis <26%
SourceThe full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), Antibody-drug conjugate (ADC) and the tag subtype-trials.
Shares HER2-positive breast cancer, Antibody-drug conjugate (ADC), Breast cancer (all types) and the tag subtype-trials.
Shares Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), Antibody-drug conjugate (ADC) and the tag subtype-trials.
Shares Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), Antibody-drug conjugate (ADC) and the tag subtype-trials.
Shares HER2-positive breast cancer with brain metastases, HER2-positive breast cancer, Breast cancer (all types) and the tag subtype-trials.
Shares HER2-positive breast cancer, Breast cancer (all types) and the tag subtype-trials.
Shares Antibody-drug conjugate (ADC) and the tag subtype-trials.
Shares Breast cancer (all types) and the tag subtype-trials.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/