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The DOI matches its Crossref record; 35 of the 35 references it cites were found in a registry or an index.

Trastuzumab deruxtecan in HER2-positive breast cancer with brain metastases: a single-arm, phase 2 trial

Open access
Bartsch, Rupert, Berghoff, Anna Sophie, Furtner, Julia, Marhold, Maximilian, Bergen, Elisabeth Sophie, Roider-Schur, Sophie, Starzer, Angelika Martina, Forstner, Heidrun, Rottenmanner, Beate, Dieckmann, Karin, Bago-Horvath, Zsuzsanna, Haslacher, Helmuth, Widhalm, Georg, Ilhan-Mutlu, Aysegül, Minichsdorfer, Christoph, Fuereder, Thorsten, Szekeres, Thomas, Oehler, Leopold, Gruenberger, Birgit, Singer, Christian F., Weltermann, Ansgar, Puhr, Rainer, Preusser, Matthias·2022·Nature Medicine

Abstract

Trastuzumab deruxtecan is an antibody–drug conjugate with high extracranial activity in human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. We conducted the prospective, open-label, single-arm, phase 2 TUXEDO-1 trial. We enrolled patients aged ≥18 years with HER2-positive breast cancer and newly diagnosed untreated brain metastases or brain metastases progressing after previous local therapy, previous exposure to trastuzumab and pertuzumab and no indication for immediate local therapy. Patients received trastuzumab deruxtecan intravenously at the standard dose of 5.4 mg per kg bodyweight once every 3 weeks. The primary endpoint was intracranial response rate measured according to the response assessment in neuro-oncology brain metastases criteria. A Simon two-stage design was used to compare a null hypothesis of <26% response rate against an alternative of 61%. Fifteen patients were enrolled in the intention-to-treat population of patients who received at least one dose of study drug. Two patients (13.3%) had a complete intracranial response, nine (60%) had a partial intracranial response and three (20%) had stable disease as the best intracranial response, with a best overall intracranial response rate of 73.3% (95% confidential interval 48.1–89.1%), thus meeting the predefined primary outcome. No new safety signals were observed and global quality-of-life and cognitive functioning were maintained over the treatment duration. In the TUXEDO-1 trial (NCT04752059, EudraCT 2020-000981-41), trastuzumab deruxtecan showed a high intracranial response rate in patients with active brain metastases from HER2-positive breast cancer and should be considered as a treatment option in this setting.

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Metadata

Authors
Bartsch, R., Berghoff, A. S., Furtner, J., Marhold, M., Bergen, E. S., Roider-Schur, S., Starzer, A. M., Forstner, H., Rottenmanner, B., Dieckmann, K., Bago-Horvath, Z., Haslacher, H., Widhalm, G., Ilhan-Mutlu, A., Minichsdorfer, C., Fuereder, T., Szekeres, T., Oehler, L., Gruenberger, B., Singer, C. F., Weltermann, A., Puhr, R., & Preusser, M.
Venue
Nature Medicine
Published
2022-08-08
Volume
28
Issue
9
Pages
1840-1847
ISSN
  • 1078-8956 (ISSN-L)
  • 1546-170X
OpenAlex
W4290673816
Cited by
389
References
35
FWCI
48.91
Type
journal article
Language
en
Open access
hybrid

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CoChat. (2026). Citation check: Trastuzumab deruxtecan in HER2-positive breast cancer with brain metastases: a single-arm, phase 2 trial. https://app.cochat.ai/papers/10.1038/s41591-022-01935-8
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Bartsch, R., Berghoff, A. S., Furtner, J., Marhold, M., Bergen, E. S., Roider-Schur, S., Starzer, A. M., Forstner, H., Rottenmanner, B., Dieckmann, K., Bago-Horvath, Z., Haslacher, H., Widhalm, G., Ilhan-Mutlu, A., Minichsdorfer, C., Fuereder, T., Szekeres, T., Oehler, L., Gruenberger, B., . . . Preusser, M. (2022). Trastuzumab deruxtecan in HER2-positive breast cancer with brain metastases: a single-arm, phase 2 trial. Nature Medicine. https://doi.org/10.1038/s41591-022-01935-8

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.