NCT05234021

HER2-directed Biosimilar in Breast Cancer: Real World ePRO

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 52 (actual)
• Sponsor: OnkoZentrum Zürich AG · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

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 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.

Conditions

• HER2-positive Breast Cancer
• Biosimilar
• Patient Reported Outcome

Timeline

• Start date: 2021-12-14
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2022-02-10
• Last updated: 2024-04-04

Locations

3 sites across 1 country: Switzerland