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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Neoplasm
• Intervention / Treatment: Drug: Neratinib

• Study Type: Observational
• Enrollment (Actual): 304

Contacts and Locations

• Study Contact: Name: Anna Resch; Phone Number: +49 761 45261; Email: eleanor_de@pierre-fabre.com
• Study Contact Backup: Name: Marion Schmoll; Phone Number: +49 761 15242; Email: eleanor@iomedico.com

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Clinic
  • Vienna, Austria, 1090
    • Clinic
  • Vienna, Austria, 1140
    • Clinic
  • Wien, Austria, 1090
    • Clinic
  • Kärnten
    • Klagenfurt, Kärnten, Austria, 9020
      • Clinic
  • Oberösterreich
    • Vöcklabruck, Oberösterreich, Austria, 4840
      • Clinic
  • Salzburg
    • Schwarzach im Pongau, Salzburg, Austria, 5620
      • Clinic
  • Steiermark
    • Graz, Steiermark, Austria, 8036
      • Clinic
• Germany
  • Berlin, Germany, 10367
    • Medical Practice
  • Berlin, Germany, 13156
    • Clinical Practice
  • Berlin, Germany, 14169
    • Medical Practice
  • Bremen, Germany, 28209
    • Medical Practice
  • Bremen, Germany, 28239
    • Clinic
  • Hamburg, Germany, 22307
    • Oncology Center
  • Baden Wuerttemberg
    • Heidelberg, Baden Wuerttemberg, Germany, 69115
      • Medical Practice
  • Baden-Wuerttemberg
    • Freiburg, Baden-Wuerttemberg, Germany, 79110
      • Community Health Center
    • Heidenheim, Baden-Wuerttemberg, Germany, 89522
      • Medical Practice
    • Schwäbisch Hall, Baden-Wuerttemberg, Germany, 74523
      • Clinic
    • Villingen-Schwenningen, Baden-Wuerttemberg, Germany, 78052
      • Medical Practice
    • Weinheim, Baden-Wuerttemberg, Germany, 69469
      • Clinic
  • Baden-Württemberg
    • Baden-Baden, Baden-Württemberg, Germany, 76532
      • Clinic
    • Nürtingen, Baden-Württemberg, Germany, 72622
      • Clinic
    • Offenburg, Baden-Württemberg, Germany, 77654
      • Oncology Center
    • Winnenden, Baden-Württemberg, Germany, 71364
      • Clinic
  • Bavaria
    • Aschaffenburg, Bavaria, Germany, 63739
      • Medical Practice
    • Augsburg, Bavaria, Germany, 86150
      • Practice
    • Deggendorf, Bavaria, Germany, 94469
      • Clinic
    • Landshut, Bavaria, Germany, 84034
      • Clinic
    • München, Bavaria, Germany, 80639
      • Community Health Center
    • München, Bavaria, Germany, 81377
      • Clinic
  • Bayern
    • Ansbach, Bayern, Germany, 91522
      • Clinic
    • Bamberg, Bayern, Germany, 96049
      • Clinic
    • Eggenfelden, Bayern, Germany, 84307
      • Community Health Center
    • Landshut, Bayern, Germany, 84036
      • Community Health Center
    • Marktredwitz, Bayern, Germany, 95615
      • Clinic
  • Brandenburg
    • Bad Liebenwerda, Brandenburg, Germany, 04924
      • Medical Practice
    • Neuruppin, Brandenburg, Germany, 16816
      • Clinic
    • Potsdam, Brandenburg, Germany, 14467
      • Clinic
  • Hessen
    • Darmstadt, Hessen, Germany, 64283
      • Clinic
    • Frankfurt, Hessen, Germany, 65929
      • Clinic
    • Wiesbaden, Hessen, Germany, 65189
      • Clinic
  • Lower Saxony
    • Goslar, Lower Saxony, Germany, 38642
      • Community Health Center
    • Göttingen, Lower Saxony, Germany, 37073
      • Practice
    • Hildesheim, Lower Saxony, Germany, 31134
      • Medical Practice
    • Leer, Lower Saxony, Germany, 26789
      • Medical Practice
    • Lüneburg, Lower Saxony, Germany, 21339
      • Clinic
    • Westerstede, Lower Saxony, Germany, 26655
      • Medical Practice
    • Wilhelmshaven, Lower Saxony, Germany, 26389
      • Medical Practice
  • Meckelnburg-Vorpommern
    • Greifswald, Meckelnburg-Vorpommern, Germany, 17489
      • Medical Practice
  • Mecklenburg-Western Pomerania
    • Rostock, Mecklenburg-Western Pomerania, Germany, 18059
      • Clinic
    • Stralsund, Mecklenburg-Western Pomerania, Germany, 18435
      • Medical Practice
  • Niedersachsen
    • Georgsmarienhütte, Niedersachsen, Germany, 49124
      • Medical Care Center
    • Hannover, Niedersachsen, Germany, 30625
      • Clinic
    • Oldenburg, Niedersachsen, Germany, 26121
      • Clinic
    • Uelzen, Niedersachsen, Germany, 29525
      • Medical Practice
  • Nordrhein-Westfalen
    • Bonn, Nordrhein-Westfalen, Germany, 53123
      • Medical Practice
    • Bottrop, Nordrhein-Westfalen, Germany, 46236
      • Medical Practice
    • Datteln, Nordrhein-Westfalen, Germany, 45711
      • Clinic
    • Essen, Nordrhein-Westfalen, Germany, 45138
      • Clininc
    • Gütersloh, Nordrhein-Westfalen, Germany, 33332
      • Medical Practice
    • Hamm, Nordrhein-Westfalen, Germany, 45711
      • Clinic
    • Köln, Nordrhein-Westfalen, Germany, 50931
      • Clinic
    • Moers, Nordrhein-Westfalen, Germany, 47441
      • Medical Practice
    • Mülheim/Ruhr, Nordrhein-Westfalen, Germany, 45468
      • Medical Practice
    • Soest, Nordrhein-Westfalen, Germany, 59494
      • Community Health Center
  • Nordrhein-westfalen
    • Köln, Nordrhein-westfalen, Germany, 51067
      • Clinic
  • North Rhine-Westphalia
    • Neuss, North Rhine-Westphalia, Germany, 41462
      • Community Health Center
    • Troisdorf, North Rhine-Westphalia, Germany, 53840
      • Medical Practice
    • Witten, North Rhine-Westphalia, Germany, 58452
      • Clinic
  • Rheinland-Pfalz
    • Mayen, Rheinland-Pfalz, Germany, 56727
      • Medical Practice
    • Neustadt, Rheinland-Pfalz, Germany, 67434
      • Clinic
  • Sachsen
    • Chemnitz, Sachsen, Germany, 09116
      • Clinic
    • Dresden, Sachsen, Germany, 01127
      • Oncology Center
    • Freital, Sachsen, Germany, 01705
      • Medical Praxis
    • Leipzig, Sachsen, Germany, 04129
      • Clinic
    • Plauen, Sachsen, Germany, 08525
      • Medical Practice
  • Sachsen-Anhalt
    • Burg, Sachsen-Anhalt, Germany, 39288
      • Medical Practice
    • Magdeburg, Sachsen-Anhalt, Germany, 39108
      • Clinic
    • Quedlinburg, Sachsen-Anhalt, Germany, 06484
      • Clinic
    • Salzwedel, Sachsen-Anhalt, Germany, 29410
      • Clinic
    • Stendal, Sachsen-Anhalt, Germany, 39576
      • Clinic
  • Saxony-Anhalt
    • Halle Saale, Saxony-Anhalt, Germany, 06110
      • Medical Practice
  • Schleswig-Holstein
    • Eutin, Schleswig-Holstein, Germany, 23701
      • Clinic
  • Theinland-Pfalz
    • Neuwied, Theinland-Pfalz, Germany, 56564
      • Medical Care Center
  • Thuringia
    • Hildburghausen, Thuringia, Germany, 98646
      • Medical Practice
  • Thüringen
    • Erfurt, Thüringen, Germany, 99084
      • Medical Practice
    • Jena, Thüringen, Germany, 07747
      • Clinic
    • Meiningen, Thüringen, Germany, 98617
      • Medical Practice
    • Neuhaus Am Rennweg, Thüringen, Germany, 98724
      • Oncology Center
    • Saalfeld, Thüringen, Germany, 07318
      • Medical Care Center
    • Suhl, Thüringen, Germany, 98527
      • Clinic
    • Suhl, Thüringen, Germany, 98527
      • Medical Practice
• Switzerland
  • Zürich, Switzerland, 8008
    • Clinic
  • Basel Stadt
    • Basel, Basel Stadt, Switzerland, 4051
      • Practice
  • Bern
    • Biel, Bern, Switzerland, 2502
      • Practice
  • Graubünden
    • Chur, Graubünden, Switzerland, 7000
      • Clinic
  • Solothurn
    • Olten, Solothurn, Switzerland, 4600
      • Clinic
  • Vaud
    • Lausanne, Vaud, Switzerland, 1003
      • Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pierre Fabre Pharma GmbH
• Collaborators: iOMEDICO AG; Pierre Fabre Pharma Austria; Pierre Fabre Pharma AG
• Investigators: Study Director: Corinne Vannier, Dr, Pierre Fabre Pharma GmbH

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2020
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: NIS07075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No