Clinical trial NCT05234021: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HER2-positive Breast Cancer
Biosimilar
Patient Reported Outcome
Keywords: ePRO
HER2
Breast Cancer
Biosimilar
Patient Reported Outcome
APP
Lead sponsor: OnkoZentrum Zürich AG
Sponsor class: OTHER
Collaborators: name: University of Zurich
name: Palleos Healthcare GmbH
First posted: 2022-02-10
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HER2 positive Breast cancer patients undergoing Anti-HER2 treatment with Ogivri

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of adverse events (AE) according to the Common Terminology Criteria for Adverse Events (CTCAE)
timeFrame: six weeks
measure: Severity of adverse events (AE) according to the Common Terminology Criteria for Adverse Events (CTCAE)
timeFrame: six weeks
Secondary outcomes:
measure: Wellbeing
timeFrame: six weeks
measure: 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.
timeFrame: six weeks
measure: Unplanned Consultations
timeFrame: nine weeks
Other outcomes:
Locations:
city: Horgen
country: Switzerland
facility: Andreas Trojan
state: Zurich
city: Rapperswil-Jona
country: Switzerland
facility: ZeTup
city: Zürich
country: Switzerland
facility: Onkologiepraxis Bellvue
Study officials:
affiliation: Seespital Horgen
name: Andreas Trojan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: