Biosimilar, HER2-positive Breast Cancer, Patient Reported Outcome
Conditions
Keywords
ePRO, HER2, Breast Cancer, Biosimilar, Patient Reported Outcome, APP
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.
Interventions
None listed
Sponsors
University of Zurich
Palleos Healthcare GmbH
OnkoZentrum Zürich AG
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events (AE) according to the Common Terminology Criteria for Adverse Events (CTCAE) | six weeks | 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. |
| Severity of adverse events (AE) according to the Common Terminology Criteria for Adverse Events (CTCAE) | six weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wellbeing | six weeks | 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. |
| 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. | six weeks | Quality of Live questionnaire will be sent to patients q 3 weeks |
| Unplanned Consultations | nine weeks | Unplanned consultations are defined as additional consultations outside of planned therapy or control visits |
Countries
Switzerland
Outcome results
None listed