ER+/HER2- Early Breast Cancer
Conditions
Brief summary
Primary efficacy IBCFS (invasive breast cancer free-survival) as defined by STEEP 2.0 criteria
Detailed description
Secondary efficacy IDFS(invasive disease-free survival) as defined by STEEP 2.0 criteria DRFS(distant relapse-free survival) as defined by STEEP 2.0 criteria OS(overall survival), Secondary safety Safety endpoints including: • TEAEs(treatment-emergent adverse event), SAEs(serious adverse event) • Clinical laboratory tests and vital signs, Secondary COAs(clinical outcome assessment): Proportion of time on study treatment with high side-effect burden as measured by the PGI-TT, Secondary COAs (clinical outcome assessment) Change from baseline and TTD(time to deterioration ) of health-related QoL(quality of life) as measured by the 2 global QoL (quality of life) items from the EORTC IL-311 (European Organisation for Research and Treatment of Cancer), Secondary PK(pharmacokinetic(s) Plasma concentrations of camizestrant pre-dose (Ctrough)( trough concentration)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy IBCFS (invasive breast cancer free-survival) as defined by STEEP 2.0 criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy IDFS(invasive disease-free survival) as defined by STEEP 2.0 criteria DRFS(distant relapse-free survival) as defined by STEEP 2.0 criteria OS(overall survival), Secondary safety Safety endpoints including: • TEAEs(treatment-emergent adverse event), SAEs(serious adverse event) • Clinical laboratory tests and vital signs, Secondary COAs(clinical outcome assessment): Proportion of time on study treatment with high side-effect burden as measured by the PGI-TT, Secondary COAs (clinical outcome assessment) Change from baseline and TTD(time to deterioration ) of health-related QoL(quality of life) as measured by the 2 global QoL (quality of life) items from the EORTC IL-311 (European Organisation for Research and Treatment of Cancer), Secondary PK(pharmacokinetic(s) Plasma concentrations of camizestrant pre-dose (Ctrough)( trough concentration) | — |
Countries
Austria, Belgium, Bulgaria, Croatia, Czechia, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Poland, Portugal, Romania, Spain