Overview
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.
Eligibility
Inclusion Criteria:
- Written informed consent of the patient with regard to the pseudonymized documentation;
- Legally capable female patient 18 years of age (no upper limit);
- Decision was taken to treat the patient with neratinib in accordance with the current SmPC and by prescription; this decision was taken prior to and independent from the inclusion into the study;
- Treatment with neratinib is planned to be started;
- Hormone receptor (HR) positive, Human epidermal growth factor receptor 2 (HER2) overexpressing/amplified breast cancer stage I-III;
- Completion of prior trastuzumab-based therapy less than 1 year ago;
- No signs of relapse before initiation of neratinib treatment.
Exclusion Criteria:
- Presence of any contraindication with regard to the neratinib treatment as specified in the corresponding Summary of Product Characteristics (SmPC);
- Current or upcoming participation in an interventional clinical trial;
- Prisoners or persons who are compulsorily detained (involuntarily incarcerated)