Document is current

Article History

Received: 2 July 2025

Accepted: 18 November 2025

First Online: 5 December 2025

Declarations

:

: RG, DJ, GG, AMR, HHW, RL, SW, FM, PMR, BH, and DM were all employees of Boehringer Ingelheim when the study analysis was conducted. FM holds a minor share of Novartis and has a patent pending: “Cancer Treatment with a HER2 Inhibitor”. RGT is an employee of ICON and was the principal investigator of the trial. The authors received no payment related to the development of this manuscript.

: This study was performed in line with the ethical principles that have their origin in the Declaration of Helsinki (October 1996 version), and the ICH Harmonized Tripartite Guideline for Good Clinical Practice and all applicable regulations. The study was approved by an independent ethics committee of Stichting Beoordeling Ethiek Biomedisch Onderzoek, Assen, The Netherlands (EU CT number 2022-503047-17-00).

: All participants provided written informed consent to participate in the study prior to the initiation of any study specific procedures.

: Not applicable.

: Data to support the findings in this study are included in the manuscript or its supplementary information. Additional data can be made available from the corresponding author on reasonable request.

: Not applicable.

: The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICMJE). RG, DJ, GG, AMA, RGT, HHW, RL, SW, PMR, BH, FM, and DM conceptualized and designed this study; RGT was responsible for investigational medicinal product preparation, clinical conduct, participant safety and laboratory analyses; RG, DJ, GG, AMA, HHW, RL, SW, PMR, BH and DM acquired data for the study analysis; all authors analyzed and/or interpreted the data; RG, DJ, GG, AMA, RGT, HHW, RL, SW, BH, FM, and DM drafted the paper, all authors critically reviewed and revised the paper. All authors have read and agreed to the published version of the manuscript and to be accountable for all aspects of the work. Boehringer Ingelheim was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.