Extended adjuvant treatment of patients with HER2+ early breast cancer with neratinib: a multi-centric, prospective, non-interventional study (NIS) in Germany and Austria (ELEANOR)
Background Neratinib is an irreversible pan-HER tyrosine kinase inhibitor registered in Europe as extended adjuvant treatment for adult patients with early-stage HR-positive, HER2-overexpressed/amplified breast cancer, who completed adjuvant trastuzumab-based therapy less than one year ago („EMA-label population“). Despite great advances in recurrence risk reduction following (post-)/(neo)adjuvant treatment for HER2-positive breast cancer, still a relevant percentage of patients relapses over time. In the EMA-label population, neratinib improved the 5-year iDFS-rate by 5.1 % compared to placebo (90.8 % vs. 85.7 %; HR 0.58 [95 % CI 0.41-0.82]) in the ExteNET study. Without systematic diarrhea prophylaxis, the most common grade 3 adverse event in these patients was diarrhea (neratinib: 39 %; placebo: 1 %; no grade 4 events).
Study design ELEANOR will be the first NIS to investigate real-world use of neratinib and its treatment management in the EMA-label population in Germany and Austria. The primary objective is to investigate the rate of patients being compliant to therapy with neratinib. Secondary objectives include characteristics of prior trastuzumab-based therapies (including other HER2-targeted therapies), neratinib doses including modifications, safety/tolerability and quality of life (QoL), among others. 200 adult female patients without any sign of relapse are planned to be documented in accordance with the EMA label and the SmPC specifications (planned documentation time frame: 2020 - 2025). CANKADO can be optionally used for QoL documentation.
This NIS will determine patient’s adherence to neratinib treatment and document extended adjuvant HER2-targeted therapy in the modern treatment landscape.
24 June 2020 (online)
© Georg Thieme Verlag KG
Stuttgart · New York