Clinical trial NCT04388384: Real-life Pan-HER-blockade With Neratinib
Official title: Neratinib in Patients With HER2+ Breast Cancer: a Multi-centric, Multi-national, Prospective, Longitudinal, Non-interventional Study in Germany, Austria and Switzerland
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Neoplasm
Lead sponsor: Pierre Fabre Pharma GmbH
Sponsor class: INDUSTRY
Collaborators: name: iOMEDICO AG
name: Pierre Fabre Pharma Austria
name: Pierre Fabre Pharma AG
First posted: 2020-05-14
Enrollment: 304
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult female patients with HR-positive, HER2-overexpressing/amplified breast cancer stage I-III having completed adjuvant trastuzumab-based therapy less than one year ago and with a decision to receive extended adjuvant treatment with neratinib according to the current SmPC.

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.


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)

Primary outcomes:
measure: Patient Compliance
timeFrame: 12 months of treatment
Secondary outcomes:
measure: Patient profile at baseline
timeFrame: Baseline
measure: Disease profiles at baseline
timeFrame: Baseline
measure: Pretreatment characteristics at baseline
timeFrame: Baseline
measure: Reason for neratinib treatment
timeFrame: Baseline
measure: Neratinib treatment characteristics
timeFrame: 12 months of treatment
measure: Neratinib treatment characteristics
timeFrame: 12 months of treatment
measure: Neratinib treatment characteristics
timeFrame: 12 months of treatment
measure: Neratinib treatment characteristics
timeFrame: 12 months of treatment
measure: Relapse of disease
timeFrame: through study completion; maximum follow-up 55 months
measure: Patient reported outcome - EQ-5D-5L
timeFrame: 12 months of treatment
measure: Patient reported outcome - STIDAT
timeFrame: 12 months of treatment
measure: Physicians' treatment satisfaction: 5 point scale
timeFrame: 12 months of treatment
measure: Patients' treatment satisfaction: 5 point scale
timeFrame: 12 months of treatment
measure: Safety and tolerability of treatment with neratinib
timeFrame: 12 months of treatment + 30 days of safety follow-up
measure: Safety and tolerability of treatment with neratinib
timeFrame: 12 months of treatment + 30 days of safety follow-up
measure: Safety and tolerability of treatment with neratinib
timeFrame: 12 months of treatment + 30 days of safety follow-up
measure: Safety and tolerability of treatment with neratinib
timeFrame: 12 months of treatment + 30 days of safety follow-up
measure: Safety and tolerability of treatment with neratinib
timeFrame: 12 months of treatment + 30 days of safety follow-up
Other outcomes:
Locations:
city: Klagenfurt
country: Austria
facility: Clinic
state: Kärnten
city: Vöcklabruck
country: Austria
facility: Clinic
state: Oberösterreich
city: Schwarzach im Pongau
country: Austria
facility: Clinic
state: Salzburg
city: Graz
country: Austria
facility: Clinic
state: Steiermark
city: Salzburg
country: Austria
facility: Clinic
city: Vienna
country: Austria
facility: Clinic
city: Vienna
country: Austria
facility: Clinic
city: Wien
country: Austria
facility: Clinic
city: Heidelberg
country: Germany
facility: Medical Practice
state: Baden Wuerttemberg
city: Freiburg
country: Germany
facility: Community Health Center
state: Baden-Wuerttemberg
city: Heidenheim
country: Germany
facility: Medical Practice
state: Baden-Wuerttemberg
city: Schwäbisch Hall
country: Germany
facility: Clinic
state: Baden-Wuerttemberg
city: Villingen-Schwenningen
country: Germany
facility: Medical Practice
state: Baden-Wuerttemberg
city: Weinheim
country: Germany
facility: Clinic
state: Baden-Wuerttemberg
city: Baden-Baden
country: Germany
facility: Clinic
state: Baden-Württemberg
city: Nürtingen
country: Germany
facility: Clinic
state: Baden-Württemberg
city: Offenburg
country: Germany
facility: Oncology Center
state: Baden-Württemberg
city: Winnenden
country: Germany
facility: Clinic
state: Baden-Württemberg
city: Aschaffenburg
country: Germany
facility: Medical Practice
state: Bavaria
city: Augsburg
country: Germany
facility: Practice
state: Bavaria
city: Deggendorf
country: Germany
facility: Clinic
state: Bavaria
city: Landshut
country: Germany
facility: Clinic
state: Bavaria
city: München
country: Germany
facility: Community Health Center
state: Bavaria
city: München
country: Germany
facility: Clinic
state: Bavaria
city: Ansbach
country: Germany
facility: Clinic
state: Bayern
city: Bamberg
country: Germany
facility: Clinic
state: Bayern
city: Eggenfelden
country: Germany
facility: Community Health Center
state: Bayern
city: Landshut
country: Germany
facility: Community Health Center
state: Bayern
city: Marktredwitz
country: Germany
facility: Clinic
state: Bayern
city: Bad Liebenwerda
country: Germany
facility: Medical Practice
state: Brandenburg
city: Neuruppin
country: Germany
facility: Clinic
state: Brandenburg
city: Potsdam
country: Germany
facility: Clinic
state: Brandenburg
city: Darmstadt
country: Germany
facility: Clinic
state: Hessen
city: Frankfurt
country: Germany
facility: Clinic
state: Hessen
city: Wiesbaden
country: Germany
facility: Clinic
state: Hessen
city: Goslar
country: Germany
facility: Community Health Center
state: Lower Saxony
city: Göttingen
country: Germany
facility: Practice
state: Lower Saxony
city: Hildesheim
country: Germany
facility: Medical Practice
state: Lower Saxony
city: Leer
country: Germany
facility: Medical Practice
state: Lower Saxony
city: Lüneburg
country: Germany
facility: Clinic
state: Lower Saxony
city: Westerstede
country: Germany
facility: Medical Practice
state: Lower Saxony
city: Wilhelmshaven
country: Germany
facility: Medical Practice
state: Lower Saxony
city: Greifswald
country: Germany
facility: Medical Practice
state: Meckelnburg-Vorpommern
city: Rostock
country: Germany
facility: Clinic
state: Mecklenburg-Western Pomerania
city: Stralsund
country: Germany
facility: Medical Practice
state: Mecklenburg-Western Pomerania
city: Georgsmarienhütte
country: Germany
facility: Medical Care Center
state: Niedersachsen
city: Hannover
country: Germany
facility: Clinic
state: Niedersachsen
city: Oldenburg
country: Germany
facility: Clinic
state: Niedersachsen
city: Uelzen
country: Germany
facility: Medical Practice
state: Niedersachsen
city: Bonn
country: Germany
facility: Medical Practice
state: Nordrhein-Westfalen
city: Bottrop
country: Germany
facility: Medical Practice
state: Nordrhein-Westfalen
city: Datteln
country: Germany
facility: Clinic
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Clininc
state: Nordrhein-Westfalen
city: Gütersloh
country: Germany
facility: Medical Practice
state: Nordrhein-Westfalen
city: Hamm
country: Germany
facility: Clinic
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Clinic
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Clinic
state: Nordrhein-westfalen
city: Moers
country: Germany
facility: Medical Practice
state: Nordrhein-Westfalen
city: Mülheim/Ruhr
country: Germany
facility: Medical Practice
state: Nordrhein-Westfalen
city: Soest
country: Germany
facility: Community Health Center
state: Nordrhein-Westfalen
city: Neuss
country: Germany
facility: Community Health Center
state: North Rhine-Westphalia
city: Troisdorf
country: Germany
facility: Medical Practice
state: North Rhine-Westphalia
city: Witten
country: Germany
facility: Clinic
state: North Rhine-Westphalia
city: Mayen
country: Germany
facility: Medical Practice
state: Rheinland-Pfalz
city: Neustadt
country: Germany
facility: Clinic
state: Rheinland-Pfalz
city: Burg
country: Germany
facility: Medical Practice
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: Clinic
state: Sachsen-Anhalt
city: Quedlinburg
country: Germany
facility: Clinic
state: Sachsen-Anhalt
city: Salzwedel
country: Germany
facility: Clinic
state: Sachsen-Anhalt
city: Stendal
country: Germany
facility: Clinic
state: Sachsen-Anhalt
city: Chemnitz
country: Germany
facility: Clinic
state: Sachsen
city: Dresden
country: Germany
facility: Oncology Center
state: Sachsen
city: Freital
country: Germany
facility: Medical Praxis
state: Sachsen
city: Leipzig
country: Germany
facility: Clinic
state: Sachsen
city: Plauen
country: Germany
facility: Medical Practice
state: Sachsen
city: Halle Saale
country: Germany
facility: Medical Practice
state: Saxony-Anhalt
city: Eutin
country: Germany
facility: Clinic
state: Schleswig-Holstein
city: Neuwied
country: Germany
facility: Medical Care center
state: Theinland-Pfalz
city: Hildburghausen
country: Germany
facility: Medical Practice
state: Thuringia
city: Erfurt
country: Germany
facility: Medical Practice
state: Thüringen
city: Jena
country: Germany
facility: Clinic
state: Thüringen
city: Meiningen
country: Germany
facility: Medical Practice
state: Thüringen
city: Neuhaus Am Rennweg
country: Germany
facility: Oncology Center
state: Thüringen
city: Saalfeld
country: Germany
facility: Medical Care Center
state: Thüringen
city: Suhl
country: Germany
facility: Clinic
state: Thüringen
city: Suhl
country: Germany
facility: Medical Practice
state: Thüringen
city: Berlin
country: Germany
facility: Medical Practice
city: Berlin
country: Germany
facility: Clinical Practice
city: Berlin
country: Germany
facility: Medical Practice
city: Bremen
country: Germany
facility: Medical Practice
city: Bremen
country: Germany
facility: Clinic
city: Hamburg
country: Germany
facility: Oncology Center
city: Basel
country: Switzerland
facility: Practice
state: Basel Stadt
city: Biel
country: Switzerland
facility: Practice
state: Bern
city: Chur
country: Switzerland
facility: Clinic
state: Graubünden
city: Olten
country: Switzerland
facility: Clinic
state: Solothurn
city: Lausanne
country: Switzerland
facility: Clinic
state: Vaud
city: Zürich
country: Switzerland
facility: Clinic
Study officials:
affiliation: Pierre Fabre Pharma GmbH
name: Corinne Vannier, Dr
role: STUDY_DIRECTOR
References: