HER2-directed Biosimilar in Breast Cancer: Real World ePRO

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HER2-positive Breast Cancer, Biosimilar, Patient Reported Outcome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events (AE) according to the Common Terminology Criteria for Adverse Events (CTCAE) | AEs according to the Common Terminology Criteria for Adverse Events (CTCAE) after six weeks as documented by the patients as ePRO via Consilium CareTM app. | six weeks | 
| Severity of adverse events (AE) according to the Common Terminology Criteria for Adverse Events (CTCAE) | AEs according to the Common Terminology Criteria for Adverse Events (CTCAE) after six weeks as documented by the patients as ePRO via Consilium CareTM app. | six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wellbeing | According to grades 0-4 (avoiding grade 5 = death) of an ECOG (Eastern Cooperative Oncology Group) Performance Status Scale, here the values are: min 0.1; max 10: higher scores in the particular utility arrangement on this app mean a better outcome. | six weeks | 
| EQ-5D-5L (European Quality of Life 5 Dimensions 5 Level Version); descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain and anxiety. Each dimension has 5 levels: (min 1; max 5); higher scores mean a worse outcome. | Quality of Live questionnaire will be sent to patients q 3 weeks | six weeks | 
| Unplanned Consultations | Unplanned consultations are defined as additional consultations outside of planned therapy or control visits | nine weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ePRO, HER2, Breast Cancer, Biosimilar, Patient Reported Outcome, APP