Real-life Pan-HER-blockade With Neratinib
ELEANOR
Neratinib in Patients With HER2+ Breast Cancer: a Multi-centric, Multi-national, Prospective, Longitudinal, Non-interventional Study in Germany, Austria and Switzerland
1 other identifier
observational
304
3 countries
97
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
Longer than P75 for all trials
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2020
CompletedFirst Posted
Study publicly available on registry
May 14, 2020
CompletedStudy Start
First participant enrolled
July 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 5, 2024
CompletedAugust 6, 2025
October 1, 2024
4.2 years
May 5, 2020
August 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (18)
Patient profile at baseline
Baseline
Disease profiles at baseline
Baseline
Pretreatment characteristics at baseline
Baseline
Reason for neratinib treatment
Baseline
Neratinib treatment characteristics
12 months of treatment
- +13 more secondary outcomes
Interventions
Eligibility Criteria
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.
You may qualify if:
- Written informed consent of the patient with regard to the pseudonymized documentation;
- Legally capable female patient ≥ 18 years of age (no upper limit);
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pierre Fabre Pharma GmbHlead
- iOMEDICO AGcollaborator
- Pierre Fabre Pharma Austriacollaborator
- Pierre Fabre Pharma AGcollaborator
Study Sites (97)
Clinic
Klagenfurt, Carinthia, 9020, Austria
Clinic
Salzburg, Salzburg, 5020, Austria
Clinic
Schwarzach im Pongau, Salzburg, 5620, Austria
Clinic
Graz, Styria, 8036, Austria
Clinic
Vöcklabruck, Upper Austria, 4840, Austria
Clinic
Vienna, Vienna, 1090, Austria
Clinic
Vienna, Vienna, 1140, Austria
Clinic
Baden-Baden, Baden-Wurttemberg, 76532, Germany
Community Health Center
Freiburg im Breisgau, Baden-Wurttemberg, 79110, Germany
Medical Practice
Heidelberg, Baden-Wurttemberg, 69115, Germany
Medical Practice
Heidenheim, Baden-Wurttemberg, 89522, Germany
Clinic
Nürtingen, Baden-Wurttemberg, 72622, Germany
Oncology Center
Offenburg, Baden-Wurttemberg, 77654, Germany
Clinic
Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany
Medical Practice
Villingen-Schwenningen, Baden-Wurttemberg, 78052, Germany
Clinic
Weinheim, Baden-Wurttemberg, 69469, Germany
Clinic
Winnenden, Baden-Wurttemberg, 71364, Germany
Clinic
Ansbach, Bavaria, 91522, Germany
Medical Practice
Aschaffenburg, Bavaria, 63739, Germany
Practice
Augsburg, Bavaria, 86150, Germany
Clinic
Bamberg, Bavaria, 96049, Germany
Clinic
Deggendorf, Bavaria, 94469, Germany
Community Health Center
Eggenfelden, Bavaria, 84307, Germany
Clinic
Landshut, Bavaria, 84034, Germany
Community Health Center
Landshut, Bavaria, 84036, Germany
Clinic
Marktredwitz, Bavaria, 95615, Germany
Community Health Center
München, Bavaria, 80639, Germany
Clinic
München, Bavaria, 81377, Germany
Medical Practice
Bad Liebenwerda, Brandenburg, 04924, Germany
Clinic
Neuruppin, Brandenburg, 16816, Germany
Clinic
Potsdam, Brandenburg, 14467, Germany
Medical Practice
Bremen, City state Bremen, 28209, Germany
Clinic
Bremen, City state Bremen, 28239, Germany
Oncology Center
Hamburg, Hamburg, 22307, Germany
Clinic
Darmstadt, Hesse, 64283, Germany
Clinic
Frankfurt am Main, Hesse, 65929, Germany
Clinic
Wiesbaden, Hesse, 65189, Germany
Medical Care Center
Georgsmarienhütte, Lower Saxony, 49124, Germany
Community Health Center
Goslar, Lower Saxony, 38642, Germany
Practice
Göttingen, Lower Saxony, 37073, Germany
Clinic
Hanover, Lower Saxony, 30625, Germany
Medical Practice
Hildesheim, Lower Saxony, 31134, Germany
Medical Practice
Leer, Lower Saxony, 26789, Germany
Clinic
Lüneburg, Lower Saxony, 21339, Germany
Clinic
Oldenburg, Lower Saxony, 26121, Germany
Medical Practice
Uelzen, Lower Saxony, 29525, Germany
Medical Practice
Westerstede, Lower Saxony, 26655, Germany
Medical Practice
Wilhelmshaven, Lower Saxony, 26389, Germany
Medical Practice
Greifswald, Meckelnburg-Vorpommern, 17489, Germany
Clinic
Rostock, Mecklenburg-Vorpommern, 18059, Germany
Medical Practice
Stralsund, Mecklenburg-Vorpommern, 18435, Germany
Medical Practice
Bonn, North Rhine-Westphalia, 53123, Germany
Medical Practice
Bottrop, North Rhine-Westphalia, 46236, Germany
Clinic
Cologne, North Rhine-Westphalia, 50931, Germany
Clinic
Cologne, North Rhine-Westphalia, 51067, Germany
Clinic
Datteln, North Rhine-Westphalia, 45711, Germany
Clininc
Essen, North Rhine-Westphalia, 45138, Germany
Medical Practice
Gütersloh, North Rhine-Westphalia, 33332, Germany
Clinic
Hamm, North Rhine-Westphalia, 45711, Germany
Medical Practice
Moers, North Rhine-Westphalia, 47441, Germany
Medical Practice
Mülheim, North Rhine-Westphalia, 45468, Germany
Community Health Center
Neuss, North Rhine-Westphalia, 41462, Germany
Community Health Center
Soest, North Rhine-Westphalia, 59494, Germany
Medical Practice
Troisdorf, North Rhine-Westphalia, 53840, Germany
Clinic
Witten, North Rhine-Westphalia, 58452, Germany
Medical Practice
Mayen, Rhineland-Palatinate, 56727, Germany
Clinic
Neustadt, Rhineland-Palatinate, 67434, Germany
Clinic
Chemnitz, Saxony, 09116, Germany
Oncology Center
Dresden, Saxony, 01127, Germany
Medical Praxis
Freital, Saxony, 01705, Germany
Clinic
Leipzig, Saxony, 04129, Germany
Medical Practice
Plauen, Saxony, 08525, Germany
Medical Practice
Burg, Saxony-Anhalt, 39288, Germany
Medical Practice
Halle, Saxony-Anhalt, 06110, Germany
Clinic
Magdeburg, Saxony-Anhalt, 39108, Germany
Clinic
Quedlinburg, Saxony-Anhalt, 06484, Germany
Clinic
Salzwedel, Saxony-Anhalt, 29410, Germany
Clinic
Stendal, Saxony-Anhalt, 39576, Germany
Clinic
Eutin, Schleswig-Holstein, 23701, Germany
Medical Practice
Berlin, State of Berlin, 10367, Germany
Clinical Practice
Berlin, State of Berlin, 13156, Germany
Medical Practice
Berlin, State of Berlin, 14169, Germany
Medical Care center
Neuwied, Theinland-Pfalz, 56564, Germany
Medical Practice
Erfurt, Thuringia, 99084, Germany
Medical Practice
Hildburghausen, Thuringia, 98646, Germany
Clinic
Jena, Thuringia, 07747, Germany
Medical Practice
Meiningen, Thuringia, 98617, Germany
Oncology Center
Neuhaus am Rennweg, Thuringia, 98724, Germany
Medical Care Center
Saalfeld, Thuringia, 07318, Germany
Clinic
Suhl, Thuringia, 98527, Germany
Medical Practice
Suhl, Thuringia, 98527, Germany
Practice
Basel, Canton of Basel-City, 4051, Switzerland
Practice
Biel/Bienne, Canton of Bern, 2502, Switzerland
Clinic
Olten, Canton of Solothurn, 4600, Switzerland
Clinic
Lausanne, Canton of Vaud, 1003, Switzerland
Clinic
Zurich, Canton of Zurich, 8008, Switzerland
Clinic
Chur, Kanton Graubünden, 7000, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Corinne Vannier, Dr
Pierre Fabre Pharma GmbH
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2020
First Posted
May 14, 2020
Study Start
July 2, 2020
Primary Completion
September 5, 2024
Study Completion
September 5, 2024
Last Updated
August 6, 2025
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share