NCT04388384

Real-life Pan-HER-blockade With Neratinib

Neratinib in Patients With HER2+ Breast Cancer: a Multi-centric, Multi-national, Prospective, Longitudinal, Non-interventional Study in Germany, Austria and Switzerland

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 304 (actual)
• Sponsor: Pierre Fabre Pharma GmbH · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

So far, there is no data available on treatment of patients with early-stage hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2)-overexpressed/amplified breast cancer, who completed adjuvant trastuzumab-based therapy less than one year ago, in the clinical routine setting. ELEANOR - designed as a prospective, longitudinal, non-interventional study (NIS) - will investigate real-world use of neratinib and its treatment management in patients with HR-positive, HER2-overexpressing/amplified breast cancer stage I-III having completed adjuvant trastuzumab-based therapy less than one year ago. Data from this study will contribute to a deeper understanding and characterization of the everyday use of neratinib in a broader patient population in the German and Austrian routine setting.

Conditions

• Breast Neoplasm

Interventions

Type	Name	Description
DRUG	Neratinib	Neratinib standard dose 240 mg once daily for 1 year

Timeline

• Start date: 2020-07-02
• Primary completion: 2024-09-05
• Completion: 2024-09-05
• First posted: 2020-05-14
• Last updated: 2025-08-06

Locations

97 sites across 3 countries: Austria, Germany, Switzerland