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Article History

Received: 28 November 2024

Accepted: 5 March 2025

First Online: 15 March 2025

Declarations

:

: The NeoOn study is an open-label, multicenter Phase IV trial evaluating the combination of the trastuzumab biosimilar ontruzant with chemotherapy in the neoadjuvant setting. The NeoOn study and the associated research projects were reviewed and approved by the relevant authority and ethics committee (leading ethical commission: ethical commission of the medical faculty at the Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany; protocol code: 550_20 Az; initial approval: May 14th 2021. Clinical trial number EudraCT:2020-001943-21; registration date December 29th 2020). The study was conducted according to the guidelines of Good Clinical Practice and the Declaration of Helsinki and all patients provided written informed consent.

: Not applicable.

: H.H. Received lecture fees from Novartis Pharma GmbH, LEO Pharma GmbH, Atlanta GmbH, and Lilly Deutschland GmbH. P.A.F. reports personal fees from Novartis, grants from Biontech, personal fees from Pfizer, personal fees from Daiichi-Sankyo, personal fees from AstraZeneca, personal fees from Eisai, personal fees from Merck Sharp & Dohme, grants from Cepheid, personal fees from Lilly, personal fees from Pierre Fabre, personal fees from Seattle Genetics, personal fees from Roche, personal fees from Hexal, during the conduct of the study. K.S. received travel support from Novartis Pharma GmbH, Gilead and Lilly Deutschland GmbH. C.G. received lecture fees from Novartis Pharma GmbH and ClinSol GmbH & Co. KG. All other authors declare that they have no competing interests.