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
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 Type
OBSERVATIONAL
Enrollment
52
Andreas Trojan
Horgen, Canton of Zurich, Switzerland
ZeTup
Rapperswil-Jona, Switzerland
Onkologiepraxis Bellvue
Zurich, Switzerland
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.
Time frame: 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.
Time frame: six weeks
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.
Time frame: 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
Time frame: six weeks
Unplanned Consultations
Unplanned consultations are defined as additional consultations outside of planned therapy or control visits
Time frame: nine weeks
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