Breast NeoplasmELEANORNCT04388384
Real-life Pan-HER-blockade With Neratinib
An observational study of Breast Neoplasm, run by Pierre Fabre Pharma GmbH at 97 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Neratinib
- How many people
- 304 participants
- Where
- 97 sitesin 3 countries
- Study dates
- 2 Jul 2020to 5 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
97 sites in 3 countries.
97 sites in 3 countries
Germany84 sites
Clinic
Ansbach, Bavaria, 91522
Medical Practice
Aschaffenburg, Bavaria, 63739
Practice
Augsburg, Bavaria, 86150
Medical Practice
Bad Liebenwerda, Brandenburg, 04924
Clinic
Baden-Baden, Baden-Wurttemberg, 76532
Clinic
Bamberg, Bavaria, 96049
Medical Practice
Berlin, State of Berlin, 10367
Clinical Practice
Berlin, State of Berlin, 13156
Medical Practice
Berlin, State of Berlin, 14169
Medical Practice
Bonn, North Rhine-Westphalia, 53123
Medical Practice
Bottrop, North Rhine-Westphalia, 46236
Medical Practice
Bremen, Free Hanseatic City of Bremen, 28209
Clinic
Bremen, Free Hanseatic City of Bremen, 28239
Medical Practice
Burg, Saxony-Anhalt, 39288
Clinic
Chemnitz, Saxony, 09116
Clinic
Cologne, North Rhine-Westphalia, 50931
Clinic
Cologne, North Rhine-Westphalia, 51067
Clinic
Darmstadt, Hesse, 64283
Clinic
Datteln, North Rhine-Westphalia, 45711
Clinic
Deggendorf, Bavaria, 94469
Oncology Center
Dresden, Saxony, 01127
Community Health Center
Eggenfelden, Bavaria, 84307
Medical Practice
Erfurt, Thuringia, 99084
Clininc
Essen, North Rhine-Westphalia, 45138
Clinic
Eutin, Schleswig-Holstein, 23701
Clinic
Frankfurt am Main, Hesse, 65929
Community Health Center
Freiburg im Breisgau, Baden-Wurttemberg, 79110
Medical Praxis
Freital, Saxony, 01705
Medical Care Center
Georgsmarienhütte, Lower Saxony, 49124
Community Health Center
Goslar, Lower Saxony, 38642
Practice
Göttingen, Lower Saxony, 37073
Medical Practice
Greifswald, Meckelnburg-Vorpommern, 17489
Medical Practice
Gütersloh, North Rhine-Westphalia, 33332
Medical Practice
Halle, Saxony-Anhalt, 06110
Oncology Center
Hamburg, Free and Hanseatic City of Hamburg, 22307
Clinic
Hamm, North Rhine-Westphalia, 45711
Clinic
Hanover, Lower Saxony, 30625
Clinic
Hansestadt Salzwedel, Saxony-Anhalt, 29410
Medical Practice
Heidelberg, Baden-Wurttemberg, 69115
Medical Practice
Heidenheim, Baden-Wurttemberg, 89522
Medical Practice
Hildburghausen, Thuringia, 98646
Medical Practice
Hildesheim, Lower Saxony, 31134
Clinic
Jena, Thuringia, 07747
Clinic
Landshut, Bavaria, 84034
Community Health Center
Landshut, Bavaria, 84036
Medical Practice
Leer, Lower Saxony, 26789
Clinic
Leipzig, Saxony, 04129
Clinic
Lüneburg, Lower Saxony, 21339
Clinic
Magdeburg, Saxony-Anhalt, 39108
Clinic
Marktredwitz, Bavaria, 95615
Medical Practice
Mayen, Rhineland-Palatinate, 56727
Medical Practice
Meiningen, Thuringia, 98617
Medical Practice
Moers, North Rhine-Westphalia, 47441
Medical Practice
Mülheim, North Rhine-Westphalia, 45468
Community Health Center
München, Bavaria, 80639
Clinic
München, Bavaria, 81377
Oncology Center
Neuhaus am Rennweg, Thuringia, 98724
Clinic
Neuruppin, Brandenburg, 16816
Community Health Center
Neuss, North Rhine-Westphalia, 41462
Clinic
Neustadt, Rhineland-Palatinate, 67434
Medical Care center
Neuwied, Theinland-Pfalz, 56564
Clinic
Nürtingen, Baden-Wurttemberg, 72622
Oncology Center
Offenburg, Baden-Wurttemberg, 77654
Clinic
Oldenburg, Lower Saxony, 26121
Medical Practice
Plauen, Saxony, 08525
Clinic
Potsdam, Brandenburg, 14467
Clinic
Quedlinburg, Saxony-Anhalt, 06484
Clinic
Rostock, Mecklenburg-Vorpommern, 18059
Medical Care Center
Saalfeld, Thuringia, 07318
Clinic
Schwäbisch Hall, Baden-Wurttemberg, 74523
Community Health Center
Soest, North Rhine-Westphalia, 59494
Clinic
Stendal, Saxony-Anhalt, 39576
Medical Practice
Stralsund, Mecklenburg-Vorpommern, 18435
Clinic
Suhl, Thuringia, 98527
Medical Practice
Suhl, Thuringia, 98527
Medical Practice
Troisdorf, North Rhine-Westphalia, 53840
Medical Practice
Uelzen, Lower Saxony, 29525
Medical Practice
Villingen-Schwenningen, Baden-Wurttemberg, 78052
Clinic
Weinheim, Baden-Wurttemberg, 69469
Medical Practice
Westerstede, Lower Saxony, 26655
Clinic
Wiesbaden, Hesse, 65189
Medical Practice
Wilhelmshaven, Lower Saxony, 26389
Clinic
Winnenden, Baden-Wurttemberg, 71364
Clinic
Witten, North Rhine-Westphalia, 58452
Austria7 sites
Clinic
Graz, Styria, 8036
Clinic
Klagenfurt, Carinthia, 9020
Clinic
Salzburg, State of Salzburg, 5020
Clinic
Schwarzach im Pongau, State of Salzburg, 5620
Clinic
Vienna, State of Vienna, 1090
Clinic
Vienna, State of Vienna, 1140
Clinic
Vöcklabruck, Upper Austria, 4840
Switzerland6 sites
Practice
Basel, Canton of Basel-City, 4051
Practice
Biel/Bienne, Canton of Bern, 2502
Clinic
Chur, Kanton Graubünden, 7000
Clinic
Lausanne, Canton of Vaud, 1003
Clinic
Olten, Canton of Solothurn, 4600
Clinic
Zurich, Canton of Zurich, 8008
About this study
Official title: 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.
- Conditions
- Breast Neoplasm
- Being tested
- Neratinib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeratinibDrug
Also called Nerlynx
Neratinib standard dose 240 mg once daily for 1 year
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months of treatment
Secondary outcomes (18)
Patient profile at baseline
% of patients with different demographic characteristics
Measured: Baseline
Disease profiles at baseline
% of patients with different disease characteristics
Measured: Baseline
Pretreatment characteristics at baseline
% of patients with different pretreatments
Measured: 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)
Measured: Baseline
Neratinib treatment characteristics
Absolute and relative dose intensity
Measured: 12 months of treatment
Neratinib treatment characteristics
% of patients with dose modification
Measured: 12 months of treatment
Neratinib treatment characteristics
% of patients with different reasons for dose modification (toxicity, concomitant disease, patient's wish, treatment holiday, other)
Measured: 12 months of treatment
Neratinib treatment characteristics
% of patients with different concomitant medications
Measured: 12 months of treatment
Relapse of disease
% of patients with relapse of disease
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 12 months of treatment
Safety and tolerability of treatment with neratinib
% of patients with adverse events overall
Measured: 12 months of treatment + 30 days of safety follow-up
Safety and tolerability of treatment with neratinib
% of patients with adverse events by intensity
Measured: 12 months of treatment + 30 days of safety follow-up
Safety and tolerability of treatment with neratinib
Time to onset of first adverse event
Measured: 12 months of treatment + 30 days of safety follow-up
Safety and tolerability of treatment with neratinib
Duration of adverse events
Measured: 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
Measured: 12 months of treatment + 30 days of safety follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start2 Jul 2020
- Primary completion5 Sep 2024
- Study completion5 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- iOMEDICO AG, Pierre Fabre Pharma Austria, Pierre Fabre Pharma AG
- Responsible party
- Sponsor
- Investigators
- Corinne Vannier, Dr, Study director, Pierre Fabre Pharma GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388384
- Sponsor's protocol ID
- NIS07075
- Acronym
- ELEANOR
- Status last verified
- Oct 2024
- First submitted
- 5 May 2020
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neratinib in Patients With HER2+ Breast Cancer: a Multi-centric, Multi-national, Prospective, Longitudinal, Non-interventional Study in Germany, Austria and Switzerland
- ClinicalTrials.gov ID
- NCT04388384
- Acronym / sponsor ID
- ELEANOR / NIS07075
- Conditions
- Breast Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Pierre Fabre Pharma GmbHIndustry (pharma, biotech, devices)
- Collaborators
- iOMEDICO AG, Pierre Fabre Pharma Austria, Pierre Fabre Pharma AG
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 14 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeratinibAlso: NerlynxNeratinib standard dose 240 mg once daily for 1 year | Drug | – |
Primary outcome
Patient Compliance
Time frame: 12 months of treatment
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.
18 secondary outcomes
Patient profile at baseline
Time frame: Baseline
Disease profiles at baseline
Time frame: Baseline
Pretreatment characteristics at baseline
Time frame: Baseline
Reason for neratinib treatment
Time frame: Baseline
Neratinib treatment characteristics
Time frame: 12 months of treatment
Neratinib treatment characteristics
Time frame: 12 months of treatment
Neratinib treatment characteristics
Time frame: 12 months of treatment
Neratinib treatment characteristics
Time frame: 12 months of treatment
Relapse of disease
Time frame: through study completion; maximum follow-up 55 months
Patient reported outcome - EQ-5D-5L
Time frame: 12 months of treatment
Patient reported outcome - STIDAT
Time frame: 12 months of treatment
Physicians' treatment satisfaction: 5 point scale
Time frame: 12 months of treatment
Patients' treatment satisfaction: 5 point scale
Time frame: 12 months of treatment
Safety and tolerability of treatment with neratinib
Time frame: 12 months of treatment + 30 days of safety follow-up
Safety and tolerability of treatment with neratinib
Time frame: 12 months of treatment + 30 days of safety follow-up
Safety and tolerability of treatment with neratinib
Time frame: 12 months of treatment + 30 days of safety follow-up
Safety and tolerability of treatment with neratinib
Time frame: 12 months of treatment + 30 days of safety follow-up
Safety and tolerability of treatment with neratinib
Time frame: 12 months of treatment + 30 days of safety follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne Vannier, Dr study director
Pierre Fabre Pharma GmbH
97 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasm, run by Pierre Fabre Pharma GmbH at 97 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 97 sites in Germany, Austria, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Compliance (time frame: 12 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.