ER + /HER 2 - Advanced Breast Cancer
Conditions
Brief summary
Study Lead-in: •Incidence of Grade 4 neutropenia AE (as graded by NCI CTCAE v5.0) with onset within the first 4 cycles. •Incidence of dose reduction or drug discontinuation within the first 4 cycles., Phase 3: •Progression-free survival (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
Study Lead-in: •Incidence of AEs and SAEs •Incidence of laboratory abnormalities. •Incidence of ECG abnormalities., Study Lead-in: •Objective Response, Clinical Benefit Response, Duration of response as determined by investigator assessment per RECIST v1.1, Study Lead-in: •Plasma concentrations of ARV-471 and ARV-473., Study Lead-in: •Plasma concentrations of palbociclib., Phase 3: •Overall Survival (OS), defined as the time from the date of randomization to the date of death due to any cause., Phase 3: •Objective Response, clinical Benefit Response, duration of response as determined by BICR assessment per RECIST v 1.1, Phase 3: •Incidence of AEs and SAEs • Incidence of laboratory abnormalities. •Incidence of ECG abnormalities., Phase 3: •Plasma concentrations of ARV-471 and its epimer ARV-473., Phase 3: •Plasma concentrations of palbociclib., Phase 3: • EuroQol EQ-5D-5L •EORTC QLQ-C30 •EORTC QLQ-BR23, Phase 3: •ctDNA plasma quantitative changes from pretreatment to evaluate potential predictability of their associations with clinical outcomes.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study Lead-in: •Incidence of Grade 4 neutropenia AE (as graded by NCI CTCAE v5.0) with onset within the first 4 cycles. •Incidence of dose reduction or drug discontinuation within the first 4 cycles., Phase 3: •Progression-free survival (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 |
|---|---|
| Study Lead-in: •Incidence of AEs and SAEs •Incidence of laboratory abnormalities. •Incidence of ECG abnormalities., Study Lead-in: •Objective Response, Clinical Benefit Response, Duration of response as determined by investigator assessment per RECIST v1.1, Study Lead-in: •Plasma concentrations of ARV-471 and ARV-473., Study Lead-in: •Plasma concentrations of palbociclib., Phase 3: •Overall Survival (OS), defined as the time from the date of randomization to the date of death due to any cause., Phase 3: •Objective Response, clinical Benefit Response, duration of response as determined by BICR assessment per RECIST v 1.1, Phase 3: •Incidence of AEs and SAEs • Incidence of laboratory abnormalities. •Incidence of ECG abnormalities., Phase 3: •Plasma concentrations of ARV-471 and its epimer ARV-473., Phase 3: •Plasma concentrations of palbociclib., Phase 3: • EuroQol EQ-5D-5L •EORTC QLQ-C30 •EORTC QLQ-BR23, Phase 3: •ctDNA plasma quantitative changes from pretreatment to evaluate potential | — |
Countries
Hungary, Italy, Slovakia, Spain