Real-life Pan-HER-blockade With Neratinib (ELEANOR)

Pierre Fabre

Status: Completed

Conditions: Breast Neoplasm

Treatments: Drug: Neratinib

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT04388384

NIS07075

Details and patient eligibility

About

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.

Enrollment: 304 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)