CompletedNot Applicable

Real-life Pan-HER-blockade With Neratinib

Austria304 participantsStarted 2020-07-02

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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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)

What they're measuring

Patient Compliance

Timeframe: 12 months of treatment

Trial details

NCT IDNCT04388384

SponsorPierre Fabre Pharma GmbH

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-09-05