Real-life Pan-HER-blockade With Neratinib

  • STATUS
    Recruiting
  • End date
    Jan 5, 2025
  • participants needed
    200
  • sponsor
    Pierre Fabre Pharma GmbH
Updated on 19 February 2024
cancer
breast cancer
epidermal growth factor receptor
growth factor
breast cancer stage
human epidermal growth factor
trastuzumab
epidermal growth factor
erbb2
breast cancer staging
immunostimulant
neratinib
adjuvant
blockade
HER2
breast neoplasm
stage i breast cancer
erbb1

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.

Details
Condition Breast Cancer, Breast Cancer
Age 18-100 years
Treatment Neratinib
Clinical Study IdentifierNCT04388384
SponsorPierre Fabre Pharma GmbH
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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