A national, multi-centre, longitudinal observational study evaluating the efficacy and safety under real-life conditions of use of TALZENNA® (talazoparib) in patients with somatic or germline BRCA mutated HER2 negative, locally advanced or metastatic breast cancer (Vital Study)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33781
• EU PAS number:
  EUPAS30803
• Study ID:
  33781
• Official title and acronym:
  A national, multi-centre, longitudinal observational study evaluating the efficacy and safety under real-life conditions of use of TALZENNA® (talazoparib) in patients with somatic or germline BRCA mutated HER2 negative, locally advanced or metastatic breast cancer (Vital Study)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  According to estimates, locally advanced or metastatic HER2- breast cancer with the germline mutation of the gene for predisposition to breast cancer (BRCA) affected 1,160 female patients in France in 2018 and therefore is considered as a rare disorder. The benefit of treatment with talazoparib in locally advanced or metastatic breast cancer with the gBRCA mutation has been demonstrated in the phase 3 pivotal study (EMBRACA). Results obtained in this phase 3 study have also been confirmed by those obtained in the phase 2 study, ABRAZO, C3441008) and in the phase 1 study, PRP-001 (C3441007). ViTAL Study is a multi-centre, ambispective, observational study. Patients will be treated in both cohorts according to the indication of the MA or of the cohort ATU. The objective of this study is to evaluate the efficacy and safety under real-life conditions of use of talazoparib in patients treated for locally advanced or metastatic HER2- breast cancer with the BRCA mutation.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

Jean-Michel Vauthier

Multiple centres: 54 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 02/09/2019

Study start date

Planned: 08/01/2020

Actual: 18/12/2019

Data analysis start date

Planned: 31/10/2024

Date of final study report

Planned: 31/05/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

PFIZER

Regulatory

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