A phase 3 randomized, double-blind, active-controlled study of palazestrant with ribociclib versus letrozole with ribociclib for the first-line treatment of ER+, HER2- advanced breast cancer (OPERA-02)

Trial status: Authorised 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 Local Investigator-assessed PFS (Progression-Free Survival)

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

Age group: 65+ years, 18-64 years Gender: Female, Male Target enrollment: 358 participants