Document is current

Article History

Received: 22 April 2022

Accepted: 2 December 2022

First Online: 11 January 2023

Declarations

:

: The KRISTINE study protocol, which included a description of preplanned exploratory biomarker analyses, received ethics approval from the institutional review board or ethics committee at each study site, and all patients provided written informed consent. The study was conducted in accordance with the International Conference on Harmonization Good Clinical Practice guidelines and the Declaration of Helsinki.

: Not applicable.

: SLdH is an employee of, and owns stock in, Roche. DJS owns stock in Pfizer, Amgen, Merck, Vertex, and Seattle Genetics; has received consulting fees from Novartis and Pfizer and research funding from Bayer and Novartis; and is a co-founder of 1200Pharma and TORL BioTherapeutics. MM has served as a consultant for F. Hoffmann-La Roche, Genentech, Novartis, and AstraZeneca. His institution has received research funding from Novartis and from Centro de Investigación Biomédica en Red in the thematic area of Breast Oncology (CIBERONC Breast), of the Instituto de Salud Carlos III (ISCIII). MFP has received research grants to his institution from Cepheid, Eli Lilly & Company, Novartis Pharmaceuticals, F. Hoffmann-La Roche Ltd, and Puma; has served as a consultant or advisor with honoraria for AstraZeneca, Biocartis SA, Cepheid, Eli Lilly & Company, Merck & Co, Puma Biotechnology, and Zymeworks Inc; has provided expert testimony for Amgen, Inc; and has private equity in TORL Biotherapeutics, LLA. GLP is an employee of Genentech and owns stock in Roche. CL is an employee of Roche. AP owns stock in Reveal Genomics; has received honoraria from Pfizer, Novartis, Roche, MSD Oncology, Lilly, Daiichi Sankyo, Amgen, and Guardant Health; has served as a consultant or advisor for Amgen, Roche, Novartis, Pfizer, Bristol-Myers Squibb, Boehringer, PUMA, Oncolytics Biotech, Daiichi Sankyo, AbbVie, AstraZeneca, and NanoString Technologies; has received research funding from Roche, Novartis, Incyte, and Puma Biotechnology; and has received royalties for patents/other intellectual property for PCT/EP2016/080056 (HER2 as a predictor of response to dual HER2 blockade in the absence of cytotoxic therapy), WO/2018/096191 (chemoendocrine score [CES] based on PAM50 for breast cancer with positive hormone receptors with an intermediate risk of recurrence), HER2DX filing, and US 63/023785 (methods for breast cancer treatment and prediction of therapeutic response. VL-V is an employee of, and owns stock in, Roche. TB is an employee from Parexel International GmbH contracted by F. Hoffmann-La Roche for statistical services in the conduct of the study. SAH has received travel support from F. Hoffmann-La Roche, Boehringer Ingelheim, Novartis, Lilly, Pfizer, and Bayer. Her institution has received research funding from Ambrx, AstraZeneca, Arvinas, Daiichi Sankyo, Dantari, G1-Therapeutics, Gilead, Immunomedics, MacroGenics, Pieris, Radius, Seattle Genetics, Zymeworks, Cytomx, Phoenix Molecular Designs, Ltd, F. Hoffmann-La Roche, Genentech, Novartis, GlaxoSmithKline, Boehringer Ingelheim, Sanofi, Pfizer, Amgen, OBI Pharma, Puma Biotechnology, Dignitana, Bayer, BioMarin, Lilly, and Merrimack.