Background
Neratinib is an oral, irreversible pan-HER tyrosine kinase inhibitor approved in Europe as extended adjuvant treatment for adult patients with HER2-positive/hormone receptor–positive early breast cancer who completed adjuvant trastuzumab-based therapy less than 1 year ago. In the phase 3 ExteNET study, neratinib significantly improved 2-year invasive disease-free survival (iDFS) (Δ4.5%, HR,0.49; 95% CI, 0.30-0.78) with an iDFS rate of 95.3% for neratinib.
Methods
ELEANOR was a prospective, observational study in female patients with HER2-positive/hormone receptor–positive early breast cancer receiving neratinib according to label in Germany, Austria, and Switzerland (NCT04388384). The primary objective was to assess adherence to neratinib (ie, neratinib intake as planned by the physician on 75% or more days).
Results
Of the 298 patients enrolled from July 2020 to May 2023 at 66 sites, 285 qualified for the main analysis set (Table), 287 for the safety set, 279 for the compliance set, and 82 for the patient-reported outcome set.
Conclusions
Real-world effectiveness data on extended adjuvant neratinib in a cohort of patients with HER2-positive/hormone receptor–positive early breast cancer who completed contemporary anti-HER2 therapies appear to be consistent with previous data. Despite a slight and transient decrease in self-rated
overall health within the first 3 months of neratinib treatment, the rate of adherent pts was high. No new safety signals were detected.
