HER2-directed Biosimilar in Breast Cancer: Real World ePRO

NCT05234021 | Completed DMC

• 1 other identifier: KEK 2021-D0051
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 3

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

Conditions

HER2-positive Breast Cancer; Biosimilar; Patient Reported Outcome

Keywords

ePRO; HER2; Breast Cancer; Biosimilar; Patient Reported Outcome; APP

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Wellbeing

  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.

  six weeks

• Unplanned Consultations

  nine weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OnkoZentrum Zürich AG: lead
• University of Zurich: collaborator
• Palleos Healthcare GmbH: collaborator

Study Sites (3)

Andreas Trojan

Horgen, Canton of Zurich, 8010, Switzerland

Location

ZeTup

Rapperswil-Jona, 8640, Switzerland

Location

Onkologiepraxis Bellvue

Zurich, 8001, Switzerland

Location

Related Publications (1)

• Trojan A, Roth S, Atassi Z, Kiessling M, Zenhaeusern R, Kadvany Y, Schumacher J, Kullak-Ublick GA, Aapro M, Eniu A. Comparison of the Real-World Reporting of Symptoms and Well-Being for the HER2-Directed Trastuzumab Biosimilar Ogivri With Registry Data for Herceptin in the Treatment of Breast Cancer: Prospective Observational Study (OGIPRO) of Electronic Patient-Reported Outcomes. JMIR Cancer. 2024 Apr 4;10:e54178. doi: 10.2196/54178.

  PMID: 38573759 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Andreas Trojan, M.D.

  Seespital Horgen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: February 10, 2022
• Study Start: December 14, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

CH (3)