HER2-directed Biosimilar in Breast Cancer: Real World ePRO (OGIPRO)

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

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

Study Overview

• Status: Completed
• Conditions: HER2-positive Breast Cancer; Biosimilar; Patient Reported Outcome

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.

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

• Study Contact: Name: Andreas Trojan, M.D.; Phone Number: +41433443333; Email: trojan@1st.ch

Study Locations

• Switzerland
  • Rapperswil-Jona, Switzerland, 8640
    • ZeTuP
  • Zürich, Switzerland, 8001
    • Onkologiepraxis Bellvue
  • Zurich
    • Horgen, Zurich, Switzerland, 8010
      • Andreas Trojan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

HER2 positive Breast cancer patients undergoing Anti-HER2 treatment with Ogivri

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: OnkoZentrum Zürich AG
• Collaborators: University of Zurich; Palleos Healthcare GmbH
• Investigators: Principal Investigator: Andreas Trojan, M.D., Seespital Horgen

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Breast Cancer; HER2; Biosimilar; ePRO; Patient Reported Outcome; APP
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: KEK 2021-D0051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No