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.
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adult female or male participants. * ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy. * Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease). * De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4/6 inhibitors) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate hematologic, hepatic, and renal functions. * Female participants can be pre-, peri- or postmenopausal. * Male and pr…
Interventions
- DrugPalazestrant
Participants will be treated with palazestrant 90 mg once daily on a 4-week (28-day) cycle.
- DrugLetrozole-matching placebo
Participants will be treated with letrozole-matching placebo once daily on a 4-week (28 day) cycle
- DrugRibociclib
Participants will be treated with ribociclib 600 mg once daily on Days 1-21 of a 4-week (28 day) cycle.
- DrugLetrozole
Participants will be treated with letrozole 2.5 mg once daily on a 4-week (28-day) cycle
- DrugPalazestrant matching-placebo
Participants will be treated with palazestrant-matching placebo once daily on a 4-week (28-day) cycle
Locations (85)
- Clinical Trial SiteHot Springs, Arkansas
- Clinical Trial SiteSanta Barbara, California
- Clinical Trial SiteDenver, Colorado
- Clinical Trial SitePeoria, Illinois
- Clinical Trial SiteAmes, Iowa
- Clinical Trial SiteScarborough, Maine