# TUXEDO-1

Source: https://onco.cc/trials/tuxedo-1/  
OnCo record `tuxedo-1` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Tags: subtype-trials
- Registry id: NCT04752059
- Phase: 2
- Setting: HER2-positive breast cancer with newly diagnosed or progressing brain metastases: single-arm trastuzumab deruxtecan
- Sponsor: Medical University of Vienna
- Enrolled: 15
- Result: Intracranial responses in most patients with active HER2-positive breast cancer brain metastases.

## Sources

- ClinicalTrials.gov NCT04752059: https://clinicaltrials.gov/study/NCT04752059

## Connected records

- cancers: [Breast cancer (all types)](https://onco.cc/cancers/breast-cancer/), [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/), [HER2-positive breast cancer with brain metastases](https://onco.cc/cancers/her2-positive-breast-brain-metastases/)
- drugs: [Trastuzumab deruxtecan](https://onco.cc/drugs/trastuzumab-deruxtecan/)
- people: [Rupert Bartsch](https://onco.cc/people/rupert-bartsch/)
- key papers: [TUXEDO-1: trastuzumab deruxtecan in HER2-positive breast cancer with active brain metastases](https://onco.cc/key-papers/paper-tuxedo-1-trastuzumab-deruxtecan-brain-metastases-nat-med-2022/)

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JSON: https://onco.cc/api/v1/entities/tuxedo-1.json