Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Drug utilisation
Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

TALZENNA

Study drug International non-proprietary name (INN) or common name

TALAZOPARIB
Population studied

Short description of the study population

Cohort 1 : “Patient treated in the setting of a cohort ATU" ; N = 75 Cohort 2 : "Patient treated in the setting of the MA" ; N = 75

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

150
Study design details

Main study objective

To evaluate the efficacy of treatment with talazoparib in patients treated for locally advanced or metastatic HER2- breast cancer with the BRCA mutation.

Outcomes

Efficacy of treatment evaluated by time to treatment discontinuation (TTD), all causes combined, defined as time between first and last dose of talazoparib or of death, Talazoparib Safety under real-life conditions of use/Time to treatment discontinuation of subsequent treatment/Overall survival/Best response to treatment with talazoparib/Time to treatment discontinuation of subsequent treatment/Duration of control of CNS metastases/Time before locoregional treatment in the central nervous system/Patient satisfaction concerning talazoparib treatment/Treatment

Data analysis plan

Analyses of demographic data will be performed in the eligible populations evaluable overall and for each cohort. No inference between groups will be presented at inclusion. If an imbalance is observed, a possible adjustment will be discussed. Analyses of efficacy will be performed in the evaluable population and the principal analysis in the 2 populations. Analyses of safety will be performed in the safety population.