Clinical Trial

Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer

Study acronym: OPERA-02
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.
Protocol Amendment History 4 changes
notable Trial sites expanded: 150 -> 167 locations 2026-07-19
notable Trial sites expanded: 124 -> 150 locations 2026-06-17
notable Trial sites expanded: 85 -> 124 locations 2026-05-16
notable Trial sites expanded: 35 -> 85 locations 2026-04-17
Trial Details
NCT Number NCT07085767
Lead Sponsor Olema Pharmaceuticals, Inc.
Collaborators: Novartis Pharmaceuticals
Conditions Breast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer, HER2 Negative Breast Carcinoma
Enrollment 1,000 participants
Start Date 2025-11-03
Primary Completion 2028-12 (estimated)
Study Completion 2032-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-17