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Completed

NCT Number: NCT05234021

HER2-directed Biosimilar in Breast Cancer: Real World ePRO

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

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Key information

Conditions

HER2-positive Breast Cancer Biosimilar Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Patient Reported Outcome Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Andreas Trojan, Horgen, Canton of Zurich, Switzerland

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of adverse events (AE) according to the Common Terminology Criteria for Adverse Events (CTCAE)

    Time frame: 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.

  2. Severity of adverse events (AE) according to the Common Terminology Criteria for Adverse Events (CTCAE)

    Time frame: 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 outcomes

  1. Wellbeing

    Time frame: 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.

  2. 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.

    Time frame: six weeks

    Quality of Live questionnaire will be sent to patients q 3 weeks

  3. Unplanned Consultations

    Time frame: nine weeks

    Unplanned consultations are defined as additional consultations outside of planned therapy or control visits

Sponsors and collaborators

Lead sponsor

OnkoZentrum Zürich AG

Other

Collaborators

  • Palleos Healthcare GmbH
  • University of Zurich

Registry information

Official study 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)

Acronym: OGIPRO

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2022
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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