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Completed

NCT Number: NCT04388384

Real-life Pan-HER-blockade With Neratinib

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.

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Key information

Conditions

Breast Neoplasm Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Clinic, Klagenfurt, Carinthia, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Neratinib

Drug

Neratinib standard dose 240 mg once daily for 1 year

Other names: Nerlynx

Primary outcomes

  1. 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.

Secondary outcomes

  1. Patient profile at baseline

    Time frame: Baseline

    % of patients with different demographic characteristics

  2. Disease profiles at baseline

    Time frame: Baseline

    % of patients with different disease characteristics

  3. Pretreatment characteristics at baseline

    Time frame: Baseline

    % of patients with different pretreatments

  4. Reason for neratinib treatment

    Time frame: Baseline

    % of patients with different reason for treatment selection (efficacy, safety profile, quality of life, patients preference, physician's preference, comorbidities, other)

  5. Neratinib treatment characteristics

    Time frame: 12 months of treatment

    Absolute and relative dose intensity

  6. Neratinib treatment characteristics

    Time frame: 12 months of treatment

    % of patients with dose modification

  7. Neratinib treatment characteristics

    Time frame: 12 months of treatment

    % of patients with different reasons for dose modification (toxicity, concomitant disease, patient's wish, treatment holiday, other)

  8. Neratinib treatment characteristics

    Time frame: 12 months of treatment

    % of patients with different concomitant medications

  9. Relapse of disease

    Time frame: through study completion; maximum follow-up 55 months

    % of patients with relapse of disease

  10. Patient reported outcome - EQ-5D-5L

    Time frame: 12 months of treatment

    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.

  11. Patient reported outcome - STIDAT

    Time frame: 12 months of treatment

    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. Physicians' treatment satisfaction: 5 point scale

    Time frame: 12 months of treatment

    % of patients with different physician satisfaction scores (5 point scale from very dissatisfied to very satisfied)

  13. Patients' treatment satisfaction: 5 point scale

    Time frame: 12 months of treatment

    % of patients with different patient satisfaction scores (5 point scale from very dissatisfied to very satisfied)

  14. Safety and tolerability of treatment with neratinib

    Time frame: 12 months of treatment + 30 days of safety follow-up

    % of patients with adverse events overall

  15. Safety and tolerability of treatment with neratinib

    Time frame: 12 months of treatment + 30 days of safety follow-up

    % of patients with adverse events by intensity

  16. Safety and tolerability of treatment with neratinib

    Time frame: 12 months of treatment + 30 days of safety follow-up

    Time to onset of first adverse event

  17. Safety and tolerability of treatment with neratinib

    Time frame: 12 months of treatment + 30 days of safety follow-up

    Duration of adverse events

  18. Safety and tolerability of treatment with neratinib

    Time frame: 12 months of treatment + 30 days of safety follow-up

    % of patients with action taken against adverse events

Sponsors and collaborators

Lead sponsor

Pierre Fabre Pharma GmbH

Industry

Collaborators

  • Pierre Fabre Pharma AG
  • Pierre Fabre Pharma Austria
  • iOMEDICO AG

Registry information

Official study title

Neratinib in Patients With HER2+ Breast Cancer: a Multi-centric, Multi-national, Prospective, Longitudinal, Non-interventional Study in Germany, Austria and Switzerland

Acronym: ELEANOR

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
May 14, 2020
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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