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

OnkoZentrum Zürich AG

Status: Completed

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05234021

KEK 2021-D0051

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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