Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
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)
Olema Pharmaceuticals, Inc.
1,000 participants
Nov 3, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Participants will be treated with palazestrant 90 mg once daily on a 4-week (28-day) cycle.
Participants will be treated with letrozole-matching placebo once daily on a 4-week (28 day) cycle
Participants will be treated with ribociclib 600 mg once daily on Days 1-21 of a 4-week (28 day) cycle.
Participants will be treated with letrozole 2.5 mg once daily on a 4-week (28-day) cycle
Participants will be treated with palazestrant-matching placebo once daily on a 4-week (28-day) cycle
Locations(85)
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NCT07085767