Real-life Pan-HER-blockade With Neratinib

Breast Neoplasm Clinical Trial

— ELEANOR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04388384
• Other study ID #: NIS07075
• Status: Active, not recruiting
• Start date: July 2, 2020
• Est. completion date: January 2025

Study information

• Verified date: October 2023
• Source: Pierre Fabre Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 304
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

Drug:
• Neratinib
Neratinib standard dose 240 mg once daily for 1 year

Locations

Country	Name	City	State
Austria	Clinic	Graz	Steiermark
Austria	Clinic	Klagenfurt	Kärnten
Austria	Clinic	Salzburg
Austria	Clinic	Schwarzach im Pongau	Salzburg
Austria	Clinic	Vienna
Austria	Clinic	Vienna
Austria	Clinic	Vöcklabruck	Oberösterreich
Austria	Clinic	Wien
Germany	Clinic	Ansbach	Bayern
Germany	Medical Practice	Aschaffenburg	Bavaria
Germany	Practice	Augsburg	Bavaria
Germany	Medical Practice	Bad Liebenwerda	Brandenburg
Germany	Clinic	Baden-Baden	Baden-Württemberg
Germany	Clinic	Bamberg	Bayern
Germany	Clinical Practice	Berlin
Germany	Medical Practice	Berlin
Germany	Medical Practice	Berlin
Germany	Medical Practice	Bonn	Nordrhein-Westfalen
Germany	Medical Practice	Bottrop	Nordrhein-Westfalen
Germany	Clinic	Bremen
Germany	Medical Practice	Bremen
Germany	Medical Practice	Burg	Sachsen-Anhalt
Germany	Clinic	Chemnitz	Sachsen
Germany	Clinic	Darmstadt	Hessen
Germany	Clinic	Datteln	Nordrhein-Westfalen
Germany	Clinic	Deggendorf	Bavaria
Germany	Oncology Center	Dresden	Sachsen
Germany	Community Health Center	Eggenfelden	Bayern
Germany	Medical Practice	Erfurt	Thüringen
Germany	Clininc	Essen	Nordrhein-Westfalen
Germany	Clinic	Eutin	Schleswig-Holstein
Germany	Clinic	Frankfurt	Hessen
Germany	Community Health Center	Freiburg	Baden-Wuerttemberg
Germany	Medical Praxis	Freital	Sachsen
Germany	Medical Care Center	Georgsmarienhütte	Niedersachsen
Germany	Community Health Center	Goslar	Lower Saxony
Germany	Practice	Göttingen	Lower Saxony
Germany	Medical Practice	Greifswald	Meckelnburg-Vorpommern
Germany	Medical Practice	Gütersloh	Nordrhein-Westfalen
Germany	Medical Practice	Halle Saale	Saxony-Anhalt
Germany	Oncology Center	Hamburg
Germany	Clinic	Hamm	Nordrhein-Westfalen
Germany	Clinic	Hannover	Niedersachsen
Germany	Medical Practice	Heidelberg	Baden Wuerttemberg
Germany	Medical Practice	Heidenheim	Baden-Wuerttemberg
Germany	Medical Practice	Hildburghausen	Thuringia
Germany	Medical Practice	Hildesheim	Lower Saxony
Germany	Clinic	Jena	Thüringen
Germany	Clinic	Köln	Nordrhein-Westfalen
Germany	Clinic	Köln	Nordrhein-westfalen
Germany	Clinic	Landshut	Bavaria
Germany	Community Health Center	Landshut	Bayern
Germany	Medical Practice	Leer	Lower Saxony
Germany	Clinic	Leipzig	Sachsen
Germany	Clinic	Lüneburg	Lower Saxony
Germany	Clinic	Magdeburg	Sachsen-Anhalt
Germany	Clinic	Marktredwitz	Bayern
Germany	Medical Practice	Mayen	Rheinland-Pfalz
Germany	Medical Practice	Meiningen	Thüringen
Germany	Medical Practice	Moers	Nordrhein-Westfalen
Germany	Medical Practice	Mülheim/Ruhr	Nordrhein-Westfalen
Germany	Clinic	München	Bavaria
Germany	Community Health Center	München	Bavaria
Germany	Oncology Center	Neuhaus Am Rennweg	Thüringen
Germany	Clinic	Neuruppin	Brandenburg
Germany	Community Health Center	Neuss	North Rhine-Westphalia
Germany	Clinic	Neustadt	Rheinland-Pfalz
Germany	Medical Care center	Neuwied	Theinland-Pfalz
Germany	Clinic	Nürtingen	Baden-Württemberg
Germany	Oncology Center	Offenburg	Baden-Württemberg
Germany	Clinic	Oldenburg	Niedersachsen
Germany	Medical Practice	Plauen	Sachsen
Germany	Clinic	Potsdam	Brandenburg
Germany	Clinic	Quedlinburg	Sachsen-Anhalt
Germany	Clinic	Rostock	Mecklenburg-Western Pomerania
Germany	Medical Care Center	Saalfeld	Thüringen
Germany	Clinic	Salzwedel	Sachsen-Anhalt
Germany	Clinic	Schwäbisch Hall	Baden-Wuerttemberg
Germany	Community Health Center	Soest	Nordrhein-Westfalen
Germany	Clinic	Stendal	Sachsen-Anhalt
Germany	Medical Practice	Stralsund	Mecklenburg-Western Pomerania
Germany	Clinic	Suhl	Thüringen
Germany	Medical Practice	Suhl	Thüringen
Germany	Medical Practice	Troisdorf	North Rhine-Westphalia
Germany	Medical Practice	Uelzen	Niedersachsen
Germany	Medical Practice	Villingen-Schwenningen	Baden-Wuerttemberg
Germany	Clinic	Weinheim	Baden-Wuerttemberg
Germany	Medical Practice	Westerstede	Lower Saxony
Germany	Clinic	Wiesbaden	Hessen
Germany	Medical Practice	Wilhelmshaven	Lower Saxony
Germany	Clinic	Winnenden	Baden-Württemberg
Germany	Clinic	Witten	North Rhine-Westphalia
Switzerland	Practice	Basel	Basel Stadt
Switzerland	Practice	Biel	Bern
Switzerland	Clinic	Chur	Graubünden
Switzerland	Clinic	Lausanne	Vaud
Switzerland	Clinic	Olten	Solothurn
Switzerland	Clinic	Zürich

Sponsors (4)

Lead Sponsor	Collaborator
Pierre Fabre Pharma GmbH	iOMEDICO AG, Pierre Fabre Pharma AG, Pierre Fabre Pharma Austria

Countries where clinical trial is conducted

Austria,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient profile at baseline	% of patients with different demographic characteristics	Baseline
Secondary	Disease profiles at baseline	% of patients with different disease characteristics	Baseline
Secondary	Pretreatment characteristics at baseline	% of patients with different pretreatments	Baseline
Secondary	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
Secondary	Neratinib treatment characteristics	Absolute and relative dose intensity	12 months of treatment
Secondary	Neratinib treatment characteristics	% of patients with dose modification	12 months of treatment
Secondary	Neratinib treatment characteristics	% of patients with different reasons for dose modification (toxicity, concomitant disease, patient's wish, treatment holiday, other)	12 months of treatment
Secondary	Neratinib treatment characteristics	% of patients with different concomitant medications	12 months of treatment
Secondary	Relapse of disease	% of patients with relapse of disease	through study completion; maximum follow-up 55 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Safety and tolerability of treatment with neratinib	% of patients with adverse events overall	12 months of treatment + 30 days of safety follow-up
Secondary	Safety and tolerability of treatment with neratinib	% of patients with adverse events by intensity	12 months of treatment + 30 days of safety follow-up
Secondary	Safety and tolerability of treatment with neratinib	Time to onset of first adverse event	12 months of treatment + 30 days of safety follow-up
Secondary	Safety and tolerability of treatment with neratinib	Duration of adverse events	12 months of treatment + 30 days of safety follow-up
Secondary	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