Trial results for a retrospective observational study of patients with early-stage HER2-positive Breast Cancer treated with neratinib were posted on ClinicalTrials.gov on 2025-10-06, involving 111 participants.
Background
HER2-positive breast cancer is an aggressive subtype that accounts for approximately 15-20% of all breast cancers. While advancements in targeted therapies have significantly improved outcomes, there remains a need for extended adjuvant strategies to further reduce recurrence risk in early-stage disease. Neratinib is an oral tyrosine kinase inhibitor approved for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy. This retrospective observational study aimed to describe the demographic and clinical profiles of patients receiving neratinib as part of an Early Access Program in Europe, providing real-world insights into this patient population.
Trial design
This completed retrospective observational study enrolled 111 participants with Breast Cancer, specifically focusing on Adjuvant Therapy for HER2-positive Breast Cancer. The study's purpose was to characterize the demographic and clinical profiles of patients with early-stage HER2-positive breast cancer who were treated with neratinib as an extended adjuvant therapy within an Early Access Program in Europe.
Key results
The study described various demographic and clinical characteristics of the enrolled participants:
- The mean age of participants was 49.2 years, with a standard deviation of 8.83 years.
- Regarding gender, 107 participants were recorded, along with another entry of 1 participant.
- The mean Body Mass Index (BMI) was 26.7 Kg/m², with a standard deviation of 5.36 Kg/m².
- Menopausal status data showed counts of 40, 5, 34, 11, 17, and 1 participants across different categories.
- 26 participants had reported comorbidities.
- HER2 overexpression/amplification testing was performed for 81 participants.
What this means
This retrospective observational study provides a detailed profile of 111 patients with early-stage HER2-positive breast cancer who received neratinib as extended adjuvant therapy through an Early Access Program in Europe. The reported demographic data, including a mean age of 49.2 years and mean BMI of 26.7 Kg/m², offers valuable real-world context for clinicians and researchers. The information on comorbidities and HER2 testing further enriches the understanding of the patient population receiving this extended adjuvant treatment, contributing to a more comprehensive picture of neratinib's use in clinical practice.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05599334, titled "A Retrospective Observational Study of Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib", were posted on 2025-10-06 on clinicaltrials.gov.