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Article History

Received: 27 May 2024

Accepted: 19 August 2024

First Online: 24 September 2024

Declarations

:

: The study was performed in accordance with good clinical practice guidelines, national laws and the Declaration of Helsinki. Informed written consent for analysis was ontained from all patients. The GeparQuattro (EudraCT 2005-001546-17) and GeparQuinto (EudraCT 2006-005834-19) studies were approved by the Ethics Committee of the special field ‘Medicine’ at the Johann Wolfgang Goethe University Frankfurt, Theodor-Stern-Kai 7, 60590 Frankfurt (ethical vote number 110/05 for GeparQuattro and 44/07 for Gepar Quinto). The GeparSixto study (EudraCT 2011-000553-23) was approved by the Ethics Committee of the Medical Association (Aerztekammer) Nordrhein, Tersteegenstr.9, 40474 Düsseldorf (ethical vote number 2011154.

: Not applicable.

: B. Sinn is an employee of BioNTech SE, has received consultancy honoraria from Sanofi and holds a pending patent WO2020109570A1. V. Nekljudova declares to be GBG Forschungs GmbH employee. GBG Forschungs GmbH received funding for research grants from Abbvie, Amgen, AstraZeneca, BMS, Daiichi-Sankyo, Gilead, Molecular Health, Novartis, Pfizer and Roche (paid to the institution); other (non-financial/medical writing) from Daiichi-Sankyo, Gilead, Novartis, Pfizer, Roche and Seagen (paid to the institution). GBG Forschungs GmbH has licensing fees from VMscope GmbH. In addition, GBG Forschungs GmbH has a patent EP21152186.9 pending, a patent EP19808852.8 pending, and a patent EP14153692.0 pending. T. Karn reports a patent for EP18209672 pending. V. Mueller reports speaker honoraria from Astra Zeneca, Daiichi-Sankyo, Eisai, Pfizer, MSD, Medac, Novartis, Roche, Seagen, Onkowissen, high5 Oncology, Medscape, Gilead, Pierre Fabre and iMED Institut; receives consultancy honoraria from Roche, Pierre Fabre, PINK, ClinSol, Novartis, MSD, Daiichi-Sankyo, Eisai, Lilly, Seagen, Gilead and Stemline; he also declares to receive institutional research support from Novartis, Roche, Seagen, Genentech and Astra Zeneca; and reports travel grants from Astra Zeneca, Roche, Pfizer, Daiichi Sankyo and Gilead. C. Schem declares honoraria from Roche, Lilly, AstraZeneca, MSD Oncology, Exact Sciences and Novartis; operate in a consulting or advisory role for Novartis, AstraZeneca and Roche; reports honoraria for speakers’ bureau from Roche, AstraZeneca and Novartis; CS also reports to receive research funding from Roche (Inst.), Daiichi Sankyo Europe GmbH (Inst.), AstraZeneca (Inst.), GlaxoSmithKline (Inst.), Novartis (Inst.) and Lilly (Inst.); and to receive travel accommodations and expenses from Pfizer, Roche, AstraZeneca, Novartis and Gilead Sciences. M. Untch reports honoraria from AstraZeneca, Art tempi, Amgen, Daiji Sankyo, Lilly, Roche, Pfizer, MSD Oncology, Pierre Fabre, Sanofi-Aventis, Myriad, Seagen, Gilead, Novartis and Stemline; to act in a consulting or advisory Role for Amgen, Lilly, Roche, Pfizer, Lilly, Pierre Fabre, Novartis, MSD Oncology, Roche, Agendia, Seagen, Gilead, Lily, Stemline, Genzyme and Onkowissen.de. All honoraria and fees to the employer/institution. J. Huober declares to receive honoraria from Lilly, Novartis, Roche, Pfizer, AstraZeneca, Seagen, Gilead and Daiichi; to have a consulting or advisory relationship with Lilly, Novartis, Roche, Pfizer, AstraZeneca, Gilead and Daiichi; and to receive honoraria for travel expenses from Roche, Novartis, Daiichi and Gilead. J. Holtschmidt reports personal fees and non-financial support from Daiichi Sankyo, non-financial support from Hologic, personal fees from MSD Oncology, Novartis, Palleos Health Care, Pfizer, Roche Pharma and Seagen, outside the submitted work; he also declares to be GBG Forschungs GmbH employee. GBG Forschungs GmbH received funding for research grants from Abbvie, Amgen, AstraZeneca, BMS, Daiichi-Sankyo, Gilead, Molecular Health, Novartis, Pfizer and Roche (paid to the institution); other (non-financial/medical writing) from Daiichi-Sankyo, Gilead, Novartis, Pfizer, Roche and Seagen (paid to the institution). GBG Forschungs GmbH has licensing fees from VMscope GmbH. In addition, GBG Forschungs GmbH has a patent EP21152186.9 pending, a patent EP19808852.8 pending, and a patent EP14153692.0 pending. M. van Mackelenbergh reiceived personal fees, honoraria or travel grants from Amgen, AstraZeneca, Daiichi Sankyo, Gilead, GSK, Lilly, Molecular Health, Mylan, MSD, Novartis, Pfizer, PierreFabre, Roche and Seagen. S. Loibl declares to be GBG Forschungs GmbH employee (CEO);The company receives grants from AbbVie, AstraZeneca, Celgene, Daiichi-Sankyo, Immunomedics/Gilead, Molecular Health, Novartis, Pfizer and Roche; honoraria for Advisory board from Abbvie, Amgen, AstraZeneca, BMS, Celgene, DSI, EirGenix, Gilead, GSK, Lilly, Merck, Novartis, Olema, Pfizer, Pierre Fabre, Relay Therapeutics, Roche, Sanofi and Seagen; honoraria as invented speaker from AstraZeneca, DSI, Gilead, Novartis, Pfizer, Roche, Seage and Medscape. S. Loibl reports non-financial interest as advisory role in AGO Kommission Mamma, PI Aphinity (principal investigator) as member in AGO, ASCO, DKG, ESMO and other non-financial interest from AstraZeneca, Daiichi-Sankyo, Gilead, Novartis, Pfizer, Roche and Seagen. GBG Forschungs GmbH has following /patents pending: EP14153692.0, EP21152186.9, EP19808852.8 and receives licensing fees from VM Scope GmbH. C.D. reports grants from European Commission H2020, grants from German Cancer Aid Translational Oncology, grants from German Breast Group, grants from BMBF, to the institution during the conduct of the study; personal fees from Novartis, personal fees from Roche, personal fees from MSD Oncology, personal fees from Daiichi Sankyo, personal fees from AstraZeneca, from Molecular Health, grants from Myriad, personal fees from Merck, other from Sividon diagnostics, outside the submitted work; In addition, Dr. Denkert has a patent VMScope digital pathology software with royalties paid, a patent WO2020109570A1—cancer immunotherapy pending, and a patent WO2015114146A1 and WO2010076322A1- therapy response issued. No other potential conflict of interest relevant to this article was reported.