Non-interventional, real-world study of patients with early stage, human epidermal growth factor receptor 2 (HER2) positive breast cancer (BC) receiving Trazimera (VESTA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/32830
• EU PAS number:
  EUPAS32829
• Study ID:
  32830
• Official title and acronym:
  Non-interventional, real-world study of patients with early stage, human epidermal growth factor receptor 2 (HER2) positive breast cancer (BC) receiving Trazimera (VESTA)
• DARWIN EU® study:
  No
• Study countries:
  Netherlands

  Norway
• Study description:
  The purpose of this observational study is to collect and analyze data in adult patients with early stage (stage 0-3) HER2 positive BC initiating treatment with Trazimera (cohort 1) or trastuzumab and transitioning to Trazimera (cohort 2) in a real-world setting. This non-interventional study (NIS) post authorization safety study (PASS) is conducted voluntarily by the marketing authorization holder. There will be no imposed experimental intervention, required visits, or study related procedures and treatment with Trazimera is determined solely by the patient’s physicians separately and irrespective of the decision to participate in this study. The data captured and reported will reflect a real-world approach to the treatment of patients with BC administered Trazimera. This is an ambispective (retrospective and prospective) observational, multi-site, multi-country, study conducted in adult patients who are receiving Trazimera as neoadjuvant or adjuvant therapy for the treatment of BC, using 2 cohorts of patients. In cohort 1, the study plans to recruit up to 200 subjects with early stage BC, in which the participating physician has decided to treat with Trazimera as Brief description of the study The purpose of this observational study is to collect and analyze data in adult patients with early stage (stage 0-3) HER2 positive BC initiating treatment with Trazimera (cohort 1) or trastuzumab and transitioning to Trazimera (cohort 2) in a real-world setting. This non-interventional study (NIS) post authorization safety study (PASS) is conducted voluntarily by the marketing authorization holder. There will be no imposed experimental intervention, required visits, or study related procedures and treatment with Trazimera is determined solely by the patient’s physicians separately and irrespective of the decision to participate in this study. The data captured and reported will reflect a real-world approach to the treatment of patients with BC administered Trazimera
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned: 12/03/2018

Actual: 12/03/2018

Study start date

Planned: 20/12/2019

Data analysis start date

Planned: 02/01/2021

Date of interim report, if expected

Planned: 30/03/2021

Date of final study report

Planned: 30/03/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer, Inc

Study protocol

Initial protocol

Pfizer B3271014 Trazimera Real World Evidence Protocol v1 05Sep2019

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable