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HER2-directed Biosimilar in Breast Cancer: Real World ePRO — OGIPRO  

HER2-positive Breast Cancer Clinical Trial

Official title:
HER2-directed Biosimilar OgivriTM in Breast Cancer: Real World Observational Trial for the Description of Quality of Life and Outcome Using ePRO (OGIPRO- Trial)

Clinical Trial 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 analytic research in order to promote the quality and efficiency of treatment

Clinical Trial 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 particular, prospectively collected data shall be compared to previously collected ePRO from women treated for HER2-positive BC in a variety of indications and settings . Since a large number of data entries for wellbeing and symptom reporting (according to CTCAE) is available from these patients, the investigators will refer to this as a historic registry data warehouse. Accordingly, the ePRO from these patients treated for HER2 positive BC are available for planned comparative analysis and shall be applied to indicate differences in anti-HER2 directed medication between Ogivri and Herceptin. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05234021
Study type Observational
Source OnkoZentrum Zürich AG
Contact
Status Completed
Phase
Start date December 14, 2021
Completion date June 30, 2023
View Details
See also
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