ER+, HER2- Advanced Breast Cancer
Conditions
Brief summary
Local Investigator-assessed PFS (Progression-Free Survival)
Detailed description
1. OS, 2. BIRC-assessed PFS, ORR, DOR and CBR, 3. Local Investigator-assessed ORR, DOR, CBR, 4. Safety and tolerability, assessed by AEs, SAEs, dose modifications, clinical laboratory parameters, ECGs, performance status, and vital sign measurements, 5. Plasma levels of palazestrant and ribociclib (in investigational arm) and of ribociclib (in control arm) at predefined intervals to establish PK parameters., 6. PRO endpoints, assessed using the EORTC QLQ- C30, EORTC QLQ-BR42 and EQ-5D-5L questionnaires, 7. Time from randomization to disease progression on first subsequent systemic anti-cancer therapy or death
Interventions
DRUGPalazestrant
DRUG-
DRUGLETROZOLE
DRUGPalazestrant matching placebo tablets and Letrozole matching placebo capsules
DRUGRIBOCICLIB
Sponsors
Olema Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local Investigator-assessed PFS (Progression-Free Survival) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. OS, 2. BIRC-assessed PFS, ORR, DOR and CBR, 3. Local Investigator-assessed ORR, DOR, CBR, 4. Safety and tolerability, assessed by AEs, SAEs, dose modifications, clinical laboratory parameters, ECGs, performance status, and vital sign measurements, 5. Plasma levels of palazestrant and ribociclib (in investigational arm) and of ribociclib (in control arm) at predefined intervals to establish PK parameters., 6. PRO endpoints, assessed using the EORTC QLQ- C30, EORTC QLQ-BR42 and EQ-5D-5L questionnaires, 7. Time from randomization to disease progression on first subsequent systemic anti-cancer therapy or death | — |
Outcome results
None listed