Real-life Pan-HER-blockade With Neratinib

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Breast Neoplasm

Intervention / Treatment
-----------------
* Drug: Neratinib


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Neratinib|Neratinib standard dose 240 mg once daily for 1 year|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Compliance | 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. | 12 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient profile at baseline | % of patients with different demographic characteristics | Baseline | 
| Disease profiles at baseline | % of patients with different disease characteristics | Baseline | 
| Pretreatment characteristics at baseline | % of patients with different pretreatments | Baseline | 
| Reason for neratinib treatment | % of patients with different reason for treatment selection (efficacy, safety profile, quality of life, patients preference, physician's preference, comorbidities, other) | Baseline | 
| Neratinib treatment characteristics | Absolute and relative dose intensity | 12 months of treatment | 
| Neratinib treatment characteristics | % of patients with dose modification | 12 months of treatment | 
| Neratinib treatment characteristics | % of patients with different reasons for dose modification (toxicity, concomitant disease, patient's wish, treatment holiday, other) | 12 months of treatment | 
| Neratinib treatment characteristics | % of patients with different concomitant medications | 12 months of treatment | 
| Relapse of disease | % of patients with relapse of disease | through study completion; maximum follow-up 55 months | 
| Patient reported outcome - EQ-5D-5L | The EQ-5D-5L is a standardized instrument for use as a measure of general health status preferences. It measures 5 dimensions of health including mobility, self-care, pain/discomfort, anxiety, and general health via a horizontal visual analog scale. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status. | 12 months of treatment | 
| Patient reported outcome - STIDAT | The Systemic Therapy Induced Diarrhea Assessment Tool (STIDAT) questionnaire is a validated, patient-reported assessment tool designed to accurately identify the presence of diarrhea and its severity using multiple bowel habit dimensions in patients with systemic therapy-induced diarrhea (STID) of multiple solid tumors who received systemic therapy with or without radiation. | 12 months of treatment | 
| Physicians' treatment satisfaction: 5 point scale | % of patients with different physician satisfaction scores (5 point scale from very dissatisfied to very satisfied) | 12 months of treatment | 
| Patients' treatment satisfaction: 5 point scale | % of patients with different patient satisfaction scores (5 point scale from very dissatisfied to very satisfied) | 12 months of treatment | 
| Safety and tolerability of treatment with neratinib | % of patients with adverse events overall | 12 months of treatment + 30 days of safety follow-up | 
| Safety and tolerability of treatment with neratinib | % of patients with adverse events by intensity | 12 months of treatment + 30 days of safety follow-up | 
| Safety and tolerability of treatment with neratinib | Time to onset of first adverse event | 12 months of treatment + 30 days of safety follow-up | 
| Safety and tolerability of treatment with neratinib | Duration of adverse events | 12 months of treatment + 30 days of safety follow-up | 
| Safety and tolerability of treatment with neratinib | % of patients with action taken against adverse events | 12 months of treatment + 30 days of safety follow-up |