Križić, Marija https://orcid.org/0000-0003-2411-6350
Silovski, Tajana https://orcid.org/0000-0002-4699-5432
Hoste, Griet https://orcid.org/0000-0002-4331-8663
Dedić Plavetić, Natalija https://orcid.org/0000-0003-0505-4756
Romano, Olivier
González Farre, Xavier https://orcid.org/0000-0002-5797-7037
Cano Jimenez, Alicia https://orcid.org/0000-0002-1582-493X
Guerrero Zotano, Angel https://orcid.org/0000-0003-0318-9120
Suissa, Jeanne
Beghdad, Farida
Dialla, Olivia
Zivanov, Marta
De Laurentiis, Michelino https://orcid.org/0000-0001-9009-1572
Clinical trials referenced in this document:
Documents that mention this clinical trial
A Retrospective Observational Study of Extended Adjuvant Neratinib for HER2-Positive Early-Stage Breast Cancer in a European Early Access Program
https://doi.org/10.1007/s40487-025-00392-w
Funding for this research was provided by:
Fondation Pierre Fabre
Article History
Received: 20 June 2025
Accepted: 8 October 2025
First Online: 29 October 2025
Declarations
:
: Marija Križić has received speaking honoraria from Roche, Servier, Novartis and AstraZeneca and institutional research funding from Roche, Novartis and Pierre Fabre outside the submitted work. Tajana Silovski has received speaking honoraria from Roche, Novartis, Pfizer, Eli Lilly and AstraZeneca and institutional research funding from Roche, Novartis and Pierre Fabre outside the submitted work. Griet Hoste declares no conflicts of interest. Natalija Dedić Plavetić has received consulting/speaking honoraria from Roche, Novartis, Pfizer, Eli Lilly, AstraZeneca, MSD, Gilead and Swixx BioPharma, as well as institutional research funding from Roche, Novartis and Pierre Fabre outside the submitted work. Olivier Romano has received consultancy/speaking honoraria from Pierre Fabre, Gilead, MSD, Daiichi Sankyo, Pfizer and Amgen. Xavier González Farre has received speaking honoraria from Pierre Fabre, AstraZeneca and Novartis, as well as travel fees from AstraZeneca and Eli Lilly. Alicia Cano Jimenez has received speaking honoraria from Pierre Fabre, Pfizer, Eli Lilly and Gilead. Angel Guerrero Zotano has received advisory/consultancy honoraria from AstraZeneca, Novartis, MSD, Pierre Fabre and Exact Science; speaking/expert testimony honoraria from Roche, AstraZeneca, Novartis, MSD, Pfizer, Lilly and Pierre Fabre; research grant/funding (institution) from Pfizer; and travel/accommodation/expenses from Roche, Novartis and Pfizer. Jeanne Suissa, Farida Beghdad and Olivia Dialla are employees of Pierre Fabre. Marta Zivanov is a former employee of Pierre Fabre. Michelino De Laurentiis has received consulting/advisory honoraria from Pfizer, AstraZeneca, Sanofi, Seagen, Novartis, Ipsen, Roche, Pierre Fabre, Daiichi Sankyo, GSK, MSD and Menarini; speaking honoraria from Eli Lilly, Novartis, Seagen, Takeda, Roche, Daiichi Sankyo, TomaLab, Gilead, Genetic, Menarini, Sophos and Istituto Gentili; and support for meeting attendance from Gilead, Novartis, Roche, AstraZeneca and Menarini.
: In Belgium, Croatia, Italy and Spain, the ethics committees of each site approved the study protocol; however, an ethical approval number was only generated for the Croatian site (number: 530-07/22-01/01), as per local regulations. Please see Supplementary Table for a full list of ethical committees. For France, ethical approval is not required for retrospective studies, and instead, this study was registered with the Health Data Hub (HDH). As this study was retrospective, the decision to prescribe neratinib was taken prior to, and independently from, the proposal to select patients for this study. Patients provided written informed consent or non-opposition and their use per study purposes as per local regulations. Consent for publication is not applicable.