Neratinib in Patients With HER2+ Breast Cancer: a Multi-centric, Multi-national, Prospective, Longitudinal, Non-interventional Study in Germany, Austria and Switzerland
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pierre Fabre Pharma GmbH
- Enrollment
- 304
- Locations
- 10
- Primary Endpoint
- Patient Compliance
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Patient Compliance
Time Frame: 12 months of treatment
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
- Patient profile at baseline(Baseline)
- Disease profiles at baseline(Baseline)
- Pretreatment characteristics at baseline(Baseline)
- Reason for neratinib treatment(Baseline)
- Neratinib treatment characteristics(12 months of treatment)
- Relapse of disease(through study completion; maximum follow-up 55 months)
- Patient reported outcome - EQ-5D-5L(12 months of treatment)
- Patients' treatment satisfaction: 5 point scale(12 months of treatment)
- Safety and tolerability of treatment with neratinib(12 months of treatment + 30 days of safety follow-up)
- Patient reported outcome - STIDAT(12 months of treatment)
- Physicians' treatment satisfaction: 5 point scale(12 months of treatment)