Status:
COMPLETED
HER2-directed Biosimilar in Breast Cancer: Real World ePRO
Lead Sponsor:
OnkoZentrum Zürich AG
Collaborating Sponsors:
University of Zurich
Palleos Healthcare GmbH
Conditions:
HER2-positive Breast Cancer
Biosimilar
Eligibility:
All Genders
18+ years
Brief Summary
This project will engage anti-HER2 directed Trastuzumab biosimilar with a novel quality of ePRO and enable comparison of reliable reference real world patient data, thereby creating a basis for analyt...
Detailed Description
Comprehensive data on patient history and follow-up modalities, AEs and outcome will be collected as ePRO to provide high-quality reports and quantitatively abundant data provided by patients. In part...
Eligibility Criteria
Inclusion
- Female patients
- Patients ≥ 18 years
- Patients with HER2-positive breast cancer (IHC-FISH/SISH)
- Undergoing Anti-HER2 treatment during the observational period containing OgivriTM (Trastuzumab) +/- Pertuzumab +/- Chemotherapy
- Personal smartphone with iOS or Android system. The operating system must be updated to one of the two newest main versions
Exclusion
- Patients, whose compliance to the studies' protocol, e.g. due to mental health problems, physical problems, or the private life situation, can be justifiably doubted
- Patients with insufficient knowledge about the use of a smartphone
Key Trial Info
Start Date :
December 14 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT05234021
Start Date
December 14 2021
End Date
June 30 2023
Last Update
April 4 2024
Active Locations (3)
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1
Andreas Trojan
Horgen, Canton of Zurich, Switzerland, 8010
2
ZeTup
Rapperswil-Jona, Switzerland, 8640
3
Onkologiepraxis Bellvue
Zurich, Switzerland, 8001