Real-life Pan-HER-blockade With Neratinib

Active, not recruiting

• Conditions: Breast Neoplasm

• Registration Number: NCT04388384
• Lead Sponsor: Pierre Fabre Pharma GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-14
• Study Start: 2020-07-02
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-24
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 304

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Patient profile at baseline	Baseline	% of patients with different demographic characteristics
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	% of patients with different concomitant medications
Relapse of disease	through study completion; maximum follow-up 55 months	% of patients with relapse of disease
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.
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)
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)
Safety and tolerability of treatment with neratinib	12 months of treatment + 30 days of safety follow-up	% of patients with action taken against adverse events

Trial Locations

Locations (10)

Community Health Center; 🇩🇪 Neuss, North Rhine-Westphalia, Germany

Medical Praxis; 🇩🇪 Freital, Sachsen, Germany

Practice; 🇨🇭 Biel, Bern, Switzerland

Clinical Practice; 🇩🇪 Berlin, Germany

Medical Care Center; 🇩🇪 Saalfeld, Thüringen, Germany

Medical Practice; 🇩🇪 Bremen, Germany

Medical Care center; 🇩🇪 Neuwied, Theinland-Pfalz, Germany

Oncology Center; 🇩🇪 Hamburg, Germany

Clininc; 🇩🇪 Essen, Nordrhein-Westfalen, Germany

Clinic; 🇨🇭 Zürich, Switzerland