Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neratinib | Drug | Neratinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Patient Compliance
- timeFrame
- 12 months of treatment
- description
- Rate of patients being compliant to therapy with neratinib. A patient is defined as being compliant, if she has taken the prescribed neratinib dose for at least 75% of the treatment days.
Secondary outcomes (18)
- measure
- Patient profile at baseline
- timeFrame
- Baseline
- description
- % of patients with different demographic characteristics
- measure
- Disease profiles at baseline
- timeFrame
- Baseline
- description
- % of patients with different disease characteristics
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available