Real-life Pan-HER-blockade With Neratinib

NCT ID: NCT04388384

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 304 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-02
• Study Completion Date: 2024-09-05

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.

Conditions

Breast Neoplasm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Neratinib

Neratinib standard dose 240 mg once daily for 1 year

Intervention Type: DRUG

Other Intervention Names

Nerlynx

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

iOMEDICO AG

INDUSTRY

Sponsor Role: collaborator

Pierre Fabre Pharma Austria

UNKNOWN

Sponsor Role: collaborator

Pierre Fabre Pharma AG

INDUSTRY

Sponsor Role: collaborator

Pierre Fabre Pharma GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Corinne Vannier, Dr

Role: STUDY_DIRECTOR

Pierre Fabre Pharma GmbH

Locations

Clinic

Klagenfurt, Carinthia, Austria

Clinic

Salzburg, Salzburg, Austria

Clinic

Schwarzach im Pongau, Salzburg, Austria

Clinic

Graz, Styria, Austria

Clinic

Vöcklabruck, Upper Austria, Austria

Clinic

Vienna, Vienna, Austria

Clinic

Vienna, Vienna, Austria

Clinic

Baden-Baden, Baden-Wurttemberg, Germany

Community Health Center

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Medical Practice

Heidelberg, Baden-Wurttemberg, Germany

Medical Practice

Heidenheim, Baden-Wurttemberg, Germany

Clinic

Nürtingen, Baden-Wurttemberg, Germany

Oncology Center

Offenburg, Baden-Wurttemberg, Germany

Clinic

Schwäbisch Hall, Baden-Wurttemberg, Germany

Medical Practice

Villingen-Schwenningen, Baden-Wurttemberg, Germany

Clinic

Weinheim, Baden-Wurttemberg, Germany

Clinic

Winnenden, Baden-Wurttemberg, Germany

Clinic

Ansbach, Bavaria, Germany

Medical Practice

Aschaffenburg, Bavaria, Germany

Practice

Augsburg, Bavaria, Germany

Clinic

Bamberg, Bavaria, Germany

Clinic

Deggendorf, Bavaria, Germany

Community Health Center

Eggenfelden, Bavaria, Germany

Clinic

Landshut, Bavaria, Germany

Community Health Center

Landshut, Bavaria, Germany

Clinic

Marktredwitz, Bavaria, Germany

Community Health Center

München, Bavaria, Germany

Clinic

München, Bavaria, Germany

Medical Practice

Bad Liebenwerda, Brandenburg, Germany

Clinic

Neuruppin, Brandenburg, Germany

Clinic

Potsdam, Brandenburg, Germany

Medical Practice

Bremen, City state Bremen, Germany

Clinic

Bremen, City state Bremen, Germany

Oncology Center

Hamburg, City state of Hamburg, Germany

Clinic

Darmstadt, Hesse, Germany

Clinic

Frankfurt am Main, Hesse, Germany

Clinic

Wiesbaden, Hesse, Germany

Medical Care Center

Georgsmarienhütte, Lower Saxony, Germany

Community Health Center

Goslar, Lower Saxony, Germany

Practice

Göttingen, Lower Saxony, Germany

Clinic

Hanover, Lower Saxony, Germany

Medical Practice

Hildesheim, Lower Saxony, Germany

Medical Practice

Leer, Lower Saxony, Germany

Clinic

Lüneburg, Lower Saxony, Germany

Clinic

Oldenburg, Lower Saxony, Germany

Medical Practice

Uelzen, Lower Saxony, Germany

Medical Practice

Westerstede, Lower Saxony, Germany

Medical Practice

Wilhelmshaven, Lower Saxony, Germany

Medical Practice

Greifswald, Meckelnburg-Vorpommern, Germany

Clinic

Rostock, Mecklenburg-Vorpommern, Germany

Medical Practice

Stralsund, Mecklenburg-Vorpommern, Germany

Medical Practice

Bonn, North Rhine-Westphalia, Germany

Medical Practice

Bottrop, North Rhine-Westphalia, Germany

Clinic

Cologne, North Rhine-Westphalia, Germany

Clinic

Cologne, North Rhine-Westphalia, Germany

Clinic

Datteln, North Rhine-Westphalia, Germany

Clininc

Essen, North Rhine-Westphalia, Germany

Medical Practice

Gütersloh, North Rhine-Westphalia, Germany

Clinic

Hamm, North Rhine-Westphalia, Germany

Medical Practice

Moers, North Rhine-Westphalia, Germany

Medical Practice

Mülheim, North Rhine-Westphalia, Germany

Community Health Center

Neuss, North Rhine-Westphalia, Germany

Community Health Center

Soest, North Rhine-Westphalia, Germany

Medical Practice

Troisdorf, North Rhine-Westphalia, Germany

Clinic

Witten, North Rhine-Westphalia, Germany

Medical Practice

Mayen, Rhineland-Palatinate, Germany

Clinic

Neustadt, Rhineland-Palatinate, Germany

Clinic

Chemnitz, Saxony, Germany

Oncology Center

Dresden, Saxony, Germany

Medical Praxis

Freital, Saxony, Germany

Clinic

Leipzig, Saxony, Germany

Medical Practice

Plauen, Saxony, Germany

Medical Practice

Burg, Saxony-Anhalt, Germany

Medical Practice

Halle, Saxony-Anhalt, Germany

Clinic

Magdeburg, Saxony-Anhalt, Germany

Clinic

Quedlinburg, Saxony-Anhalt, Germany

Clinic

Salzwedel, Saxony-Anhalt, Germany

Clinic

Stendal, Saxony-Anhalt, Germany

Clinic

Eutin, Schleswig-Holstein, Germany

Medical Practice

Berlin, State of Berlin, Germany

Clinical Practice

Berlin, State of Berlin, Germany

Medical Practice

Berlin, State of Berlin, Germany

Medical Care center

Neuwied, Theinland-Pfalz, Germany

Medical Practice

Erfurt, Thuringia, Germany

Medical Practice

Hildburghausen, Thuringia, Germany

Clinic

Jena, Thuringia, Germany

Medical Practice

Meiningen, Thuringia, Germany

Oncology Center

Neuhaus am Rennweg, Thuringia, Germany

Medical Care Center

Saalfeld, Thuringia, Germany

Clinic

Suhl, Thuringia, Germany

Medical Practice

Suhl, Thuringia, Germany

Practice

Basel, Canton of Basel-City, Switzerland

Practice

Biel/Bienne, Canton of Bern, Switzerland

Clinic

Olten, Canton of Solothurn, Switzerland

Clinic

Lausanne, Canton of Vaud, Switzerland

Clinic

Zurich, Canton of Zurich, Switzerland

Clinic

Chur, Kanton Graubünden, Switzerland

Countries

Austria; Germany; Switzerland

Other Identifiers

NIS07075

Identifier Type: -

Identifier Source: org_study_id