HR+, HER2- breast cancer at high risk of recurrence
Conditions
Brief summary
The probability of severe diarrhoea (grades 2, 3 and 4 according to CTCAE v5.0) occurring as a result of exposure to abemaciclib and its metabolites will be characterised by a mixed-effects joint model, combining longitudinal, pharmacokinetic (continuous) and toxicity (survival) data.
Detailed description
The probability of severe neutropenia (grades 3 and 4 according to the current CTCAE) occurring as a result of exposure to abemaciclib and its metabolites will be characterised by a mixed-effects joint model, combining longitudinal pharmacokinetic data pharmacokinetic (continuous type) and pharmacodynamic (neutrophil concentration, continuous type) data., Validation of the mixed-effects PK/PD model using standard diagnostic tools (diagnostic plots of data fit, visual predictive checks, estimation precision, shrinkage)., The ‘fu’ of abemaciclib concentrations will be modelled within the mixed-effects PK/PD model, and any correlation with clinical and biological covariates will be evaluated.
Interventions
DRUGVerzenios 50 mg film-coated tablets
Sponsors
Centre Hospitalier Universitaire De Poitiers
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The probability of severe diarrhoea (grades 2, 3 and 4 according to CTCAE v5.0) occurring as a result of exposure to abemaciclib and its metabolites will be characterised by a mixed-effects joint model, combining longitudinal, pharmacokinetic (continuous) and toxicity (survival) data. | — |
Secondary
| Measure | Time frame |
|---|---|
| The probability of severe neutropenia (grades 3 and 4 according to the current CTCAE) occurring as a result of exposure to abemaciclib and its metabolites will be characterised by a mixed-effects joint model, combining longitudinal pharmacokinetic data pharmacokinetic (continuous type) and pharmacodynamic (neutrophil concentration, continuous type) data., Validation of the mixed-effects PK/PD model using standard diagnostic tools (diagnostic plots of data fit, visual predictive checks, estimation precision, shrinkage)., The ‘fu’ of abemaciclib concentrations will be modelled within the mixed-effects PK/PD model, and any correlation with clinical and biological covariates will be evaluated. | — |
Countries
France
Outcome results
None listed