Breast Neoplasm
Conditions
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.
Interventions
DRUGNeratinib
Neratinib standard dose 240 mg once daily for 1 year
Sponsors
iOMEDICO AG
Pierre Fabre Pharma Austria
Pierre Fabre Pharma AG
Pierre Fabre Pharma GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Compliance | 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
| Measure | Time frame | Description |
|---|---|---|
| Disease profiles at baseline | Baseline | % of patients with different disease characteristics |
| Pretreatment characteristics at baseline | Baseline | % of patients with different pretreatments |
| Reason for neratinib treatment | Baseline | % of patients with different reason for treatment selection (efficacy, safety profile, quality of life, patients preference, physician's preference, comorbidities, other) |
| Neratinib treatment characteristics | 12 months of treatment | Absolute and relative dose intensity |
| Relapse of disease | through study completion; maximum follow-up 55 months | % of patients with relapse of disease |
| Patient profile at baseline | Baseline | % of patients with different demographic characteristics |
| Patient reported outcome - STIDAT | 12 months of treatment | 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. |
| Physicians' treatment satisfaction: 5 point scale | 12 months of treatment | % of patients with different physician satisfaction scores (5 point scale from very dissatisfied to very satisfied) |
| Patients' treatment satisfaction: 5 point scale | 12 months of treatment | % of patients with different patient satisfaction scores (5 point scale from very dissatisfied to very satisfied) |
| Safety and tolerability of treatment with neratinib | 12 months of treatment + 30 days of safety follow-up | % of patients with adverse events overall |
| Patient reported outcome - EQ-5D-5L | 12 months of treatment | 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. |
Countries
Austria, Germany, Switzerland
Outcome results
None listed