Treatment of HER2+/HR+early breast cancer with neratinib: final results from a retrospective single case report retrieval project

Purpose: Neratinib is an oral, irreversible pan-HER tyrosine kinase inhibitor approved in Europe as extended adjuvant treatment for adult patients with HER2+/HR+early breast cancer (eBC) who completed adjuvant trastuzumab-based therapy<1 year ago. In the phase III ExteNET study, neratinib significantly improved 5-year invasive disease-free survival (Δ5.1%, HR 0.58, 95%CI 0.41-0.82).

This retrospective single case report project aims to collect real-world data on treatment management of patients with HER2+/HR+eBC who received extended adjuvant neratinib in different treatment scenarios.

Material and Methods: Single case reports of adult patients with HER2+/HR+eBC treated with neratinib for≥3 months were selected based on the following treatment scenarios by participating sites in Germany and Austria:

I: adjuvant trastuzumab (T)

II: adjuvant trastuzumab+pertuzumab (T+P)

IIIa: pathological complete response (pCR) after neoadjuvant T+P, post-neoadjuvant T

IIIb: pCR after neoadjuvant T+P, post-neoadjuvant T+P

IV: non-pCR after neoadjuvant T+P, post-neoadjuvant T-emtansine (T-DM1)

Results: Twenty-seven case reports were documented at 8 sites (first-patient-in: 21-Aug-2023, last-patient-in: 27-Jan-2025). Representative patient cases will be presented including patient, disease and treatment characteristics as well as neratinib safety profile.

Conclusions: Patient cases collected within this project provide interesting insights on treatment situations of patients with HER2+/HR+eBC treated with (neo)adjuvant anti-HER2 therapy and extended adjuvant neratinib in Germany and Austria. These data could serve as a basis for clinical practice discussions in the management of HER2+/HR+eBC.

Funded by Pierre Fabre Pharma.

 

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Interessenskonflikt

Ich erkläre als korrespondierende/r AutorIn, dass ich oder einer bzw. mehrere meiner Ko-AutorenInnen während der letzten 3 Jahre wirtschaftliche oder persönliche Verbindungen im oben genannten Sinne hatten: Interessenskonflikt Details: Rachel Wuerstlein: Agendia, Amgen, APOGHEVA, Aristo, AstraZeneca, Celgene, Clinsol, Daiichi-Sankyo, Eisai, Esteve, Exact Sciences, Gilead, Glaxo Smith Kline, Hexal/Sandoz, H+O Communications, Lilly, MSD, Mundipharma, Mylan, Nanostring, Novartis, Onkowissen, Paxman, Palleos, Pfizer, Pierre Fabre, PINK, Riemser, Roche, Seagen, Sidekick, Stemline, streamed up, Tesaro Bio, Teva, Veracyte, Viatris, Wiley. Mark-Oliver Zahn: Shares of companies: Gilead, Bayer, IOMEDICO; Consultancy/lectures: Novartis, AstraZeneca Dirk-Toralf Baerens: Advisory board/speaker/study participation: Gedeon Richter, Novartis, Gilead, Abbvie, Pierre Fabre, Pfizer, Onkovis; Ärztekammer Niedersachsen. Dagmar Guth: Honorary (lectures): Amgen, AstraZeneca, Celgene, Gilead, Janssen, Lilly, Novartis, Pharma Mar, Pfizer, Roche; Congress/event participation: Amgen, AstraZeneca, Celgene, Gilead, Janssen, Novartis, Pfizer, Roche Ursula Pluschnig, Thomas Göhler: No conflicts of interest. Corinne Vannier: Employee of Pierre Fabre GmbH. Wolfgang Janni: Research grants and/or honoraria from: AstraZeneca, Cellgene, Chugai, Daiichi-Sankyo, Eisai, ExactScience, GSK, Janssen, Lilly, Menarini, MSD, Novartis, Sanofi-Aventis, Roche, Pfizer, Seagen, Gilead, Inivata, Guardant Health Edgar Petru: Honorary for lectures and advisory boards. Nicolai Maass: Lectures/consulting/travelling: Amgen, AstraZeneca, Gilead, MSD, Mylan, Novartis, Pfizer, Roche.

Publication History

Article published online:
04 June 2025