Advanced Breast Cancer
Conditions
Brief summary
PFS, defined as the time from the date of randomization to the date of first documented disease progression, as determined by BICR assessment per RECIST v1.1, or death due to any cause, whichever occurs first.
Detailed description
OS, defined as the time from the date of randomization to the date of death due to any cause., OR: confirmed CR or PR by BICR assessment • CBR defined as confirmed CR or PR at any time or SD or non-CR/non-PD ≥24 weeks by BICR assessment • DOR by BICR assessment, Type, incidence, severity (as graded by NCI CTCAE v5.0), seriousness and relationship to study medications of AEs and any laboratory and ECG abnormalities., QTc, EORTC QLQ-C30 • EORTC QLQ-BR23 • EuroQol; EQ-5D-5L • BPI-SF., Plasma concentrations of ARV-471 and its epimer ARV-473., ctDNA plasma quantitative changes from baseline to evaluate their associations with clinical outcomes.
Interventions
DRUGFulvestrant EVER Pharma
DRUG250 mg/ 5 ml
DRUGroztwór do wstrzykiwań w ampułko-strzykawce
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS, defined as the time from the date of randomization to the date of first documented disease progression, as determined by BICR assessment per RECIST v1.1, or death due to any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| OS, defined as the time from the date of randomization to the date of death due to any cause., OR: confirmed CR or PR by BICR assessment • CBR defined as confirmed CR or PR at any time or SD or non-CR/non-PD ≥24 weeks by BICR assessment • DOR by BICR assessment, Type, incidence, severity (as graded by NCI CTCAE v5.0), seriousness and relationship to study medications of AEs and any laboratory and ECG abnormalities., QTc, EORTC QLQ-C30 • EORTC QLQ-BR23 • EuroQol; EQ-5D-5L • BPI-SF., Plasma concentrations of ARV-471 and its epimer ARV-473., ctDNA plasma quantitative changes from baseline to evaluate their associations with clinical outcomes. | — |
Countries
Austria, Belgium, Bulgaria, Czechia, Finland, France, Germany, Greece, Hungary, Italy, Norway, Poland, Slovakia, Spain, Sweden
Outcome results
None listed