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)
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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 pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.
Locations
United States
Iowa
Clinical Trial Site
NOT_YET_RECRUITING
Ames
Maine
Clinical Trial Site
NOT_YET_RECRUITING
Scarborough
Missouri
Clinical Trial Site
NOT_YET_RECRUITING
Kansas City
New Mexico
Clinical Trial Site
RECRUITING
Santa Fe
Pennsylvania
Clinical Trial Site
RECRUITING
Sayre
Tennessee
Clinical Trial Site
NOT_YET_RECRUITING
Tennessee City
Utah
Clinical Trial Site
NOT_YET_RECRUITING
Salt Lake City
Other Locations
Australia
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Adelaide
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Clayton
Clinical Trial Site
NOT_YET_RECRUITING
Geelong
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Macquarie University
Clinical Trial Site
ACTIVE_NOT_RECRUITING
Nedlands
Contact Information
Primary
Olema Pharmaceuticals, Inc.
OPERA-02@olema.com
415-651-7206
Time Frame
Start Date:2025-11-03
Estimated Completion Date:2032-01
Participants
Target number of participants:1000
Treatments
Experimental: Palazestrant
Participants will receive palazestrant, ribociclib and letrozole-matching placebo
Active_comparator: Letrozole
Participants will receive letrozole, ribociclib and palazestrant-matching placebo