Status:
COMPLETED
Real-life Pan-HER-blockade With Neratinib
Lead Sponsor:
Pierre Fabre Pharma GmbH
Collaborating Sponsors:
iOMEDICO AG
Pierre Fabre Pharma Austria
Conditions:
Breast Neoplasm
Eligibility:
FEMALE
18+ years
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 2 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 5 2024
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT04388384
Start Date
July 2 2020
End Date
September 5 2024
Last Update
August 6 2025
Active Locations (97)
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1
Clinic
Klagenfurt, Carinthia, Austria, 9020
2
Clinic
Salzburg, Salzburg, Austria, 5020
3
Clinic
Schwarzach im Pongau, Salzburg, Austria, 5620
4
Clinic
Graz, Styria, Austria, 8036