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)
This is an international, multicenter, randomized, double-blind, active-controlled, phase 3 clinical trial. The purpose of this trial is to compare the efficacy and safety of palazestrant in combination with ribociclib +letrozole -matching placebo (Arm A: investigational arm) with letrozole in combination with ribociclib + palazestrant-matching placebo (Arm B: control arm). This trial is seeking adult participants with ER+, HER2- advanced breast cancer who have not received prior systemic anti-cancer treatment for advanced disease. Approximately 1,000 participants will be randomized in a 1:1 ratio to one of the two study arms.
Why this Research Matters
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.
Who can Participate
Inclusion Criteria Adult female or male participants. ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy. De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4/6 inhibitors) Detailed eligibility criteria is available on ClinicalTrials.gov. These requirements will be discussed with your doctor and/or study representative. ClinicalTrials.gov to learn more about this study.
Study ID
Protocol Number: 25-2524
More information available at ClinicalTrials.gov: NCT07085767
Meet the Team
Principal Investigator