Spots Global Cancer Trial Database for HER2-directed Biosimilar in Breast Cancer: Real World ePRO

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Trial Identification

Brief Title: HER2-directed Biosimilar in Breast Cancer: Real World ePRO

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)

Study ID: NCT05234021

Conditions

HER2-positive Breast Cancer

Biosimilar

Patient Reported Outcome

Interventions

Study Description

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 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.