HER2-directed Biosimilar in Breast Cancer: Real World ePRO

HER2-positive Breast Cancer Clinical Trial

— OGIPRO  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05234021
• Other study ID #: KEK 2021-D0051
• Status: Completed
• Start date: December 14, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2024
• Source: OnkoZentrum Zürich AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer
• Patient Reported Outcome

Locations

Country	Name	City	State
Switzerland	Andreas Trojan	Horgen	Zurich
Switzerland	ZeTup	Rapperswil-Jona
Switzerland	Onkologiepraxis Bellvue	Zürich

Sponsors (3)

Lead Sponsor	Collaborator
OnkoZentrum Zürich AG	Palleos Healthcare GmbH, University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Unplanned Consultations	Unplanned consultations are defined as additional consultations outside of planned therapy or control visits	nine weeks