Real-life Pan-HER-blockade With Neratinib

NCT04388384 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 304

Last updated 2025-08-06

No results posted yet for this study

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

Interventions

DRUG

Neratinib

Neratinib standard dose 240 mg once daily for 1 year

Sponsors & Collaborators

  • iOMEDICO AG

    collaborator INDUSTRY
  • Pierre Fabre Pharma Austria

    collaborator UNKNOWN
  • Pierre Fabre Pharma AG

    collaborator INDUSTRY
  • Pierre Fabre Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Corinne Vannier, Dr · Pierre Fabre Pharma GmbH

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-02
Primary Completion
2024-09-05
Completion
2024-09-05

Countries

  • Austria
  • Germany
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04388384 on ClinicalTrials.gov