Clinical Research Directory
Browse clinical research sites, groups, and studies.
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
Sponsor: 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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2025-11-03
Completion Date
2032-01
Last Updated
2026-09-23
Healthy Volunteers
No
Conditions
Interventions
Palazestrant
Participants will be treated with palazestrant 90 mg once daily on a 4-week (28-day) cycle.
Letrozole-matching placebo
Participants will be treated with letrozole-matching placebo once daily on a 4-week (28 day) cycle
Ribociclib
Participants will be treated with ribociclib 600 mg once daily on Days 1-21 of a 4-week (28 day) cycle.
Letrozole
Participants will be treated with letrozole 2.5 mg once daily on a 4-week (28-day) cycle
Palazestrant matching-placebo
Participants will be treated with palazestrant-matching placebo once daily on a 4-week (28-day) cycle
Locations (200)
Clinical Trial Site
Hot Springs, Arkansas, United States
Clinical Trial Site
Beverly Hills, California, United States
Clinical Trial Site
La Jolla, California, United States
Clinical Trial Site
Los Alamitos, California, United States
Clinical Trial Site
Oakland, California, United States
Clinical Trial Site
Roseville, California, United States
Clinical Trial Site
San Francisco, California, United States
Clinical Trial Site
San Francisco, California, United States
Clinical Trial Site
Santa Barbara, California, United States
Clinical Trial Site
Santa Clara, California, United States
Clinical Trial Site
Vallejo, California, United States
Clinical Trial Site
Walnut Creek, California, United States
Clinical Trial Site
Aurora, Colorado, United States
Clinical Trial Site
Denver, Colorado, United States
Clinical Trial Site
New Haven, Connecticut, United States
Clinical Trial Site
Tampa, Florida, United States
Clinical Trial Site
Marietta, Georgia, United States
Clinical Trial Site
Honolulu, Hawaii, United States
Clinical Trial Site
Peoria, Illinois, United States
Clinical Trial Site
Urbana, Illinois, United States
Clinical Trial Site
Ames, Iowa, United States
Clinical Trial Site
Scarborough, Maine, United States
Clinical Trial Site
Annapolis, Maryland, United States
Clinical Trial Site
Baltimore, Maryland, United States
Clinical Trial Site
Baltimore, Maryland, United States
Clinical Trial Site
Catonsville, Maryland, United States
Clinical Trial Site
Burlington, Massachusetts, United States
Clinical Trial Site
Ann Arbor, Michigan, United States
Clinical Trial Site
Minneapolis, Minnesota, United States
Clinical Trial Site
Jackson, Mississippi, United States
Clinical Trial Site
Kansas City, Missouri, United States
Clinical Trial Site
Lebanon, New Hampshire, United States
Clinical Trial Site
Santa Fe, New Mexico, United States
Clinical Trial Site
New York, New York, United States
Clinical Trial Site
New York, New York, United States
Clinical Trial Site
Charlotte, North Carolina, United States
Clinical Trial Site
Durham, North Carolina, United States
Clinical Trial Site
Cincinnati, Ohio, United States
Clinical Trial Site
Columbus, Ohio, United States
Clinical Trial Site
Columbus, Ohio, United States
Clinical Trial Site
Portland, Oregon, United States
Clinical Trial Site
Horsham, Pennsylvania, United States
Clinical Trial Site
Sayre, Pennsylvania, United States
Clinical Trial Site
Bartlett, Tennessee, United States
Clinical Trial Site
Knoxville, Tennessee, United States
Clinical Trial Site
Mount Juliet, Tennessee, United States
Clinical Trial Site
Nashville, Tennessee, United States
Clinical Trial Site
Tennessee City, Tennessee, United States
Clinical Trial Site
Dallas, Texas, United States
Clinical Trial Site
Dallas, Texas, United States
Clinical Trial Site
Denton, Texas, United States
Clinical Trial Site
El Paso, Texas, United States
Clinical Trial Site
Houston, Texas, United States
Clinical Trial Site
San Antonio, Texas, United States
Clinical Trial Site
Salt Lake City, Utah, United States
Clinical Trial Site
Fort Belvoir, Virginia, United States
Clinical Trial Site
Midlothian, Virginia, United States
Clinical Trial Site
Norfolk, Virginia, United States
Clinical Trial Site
Olympia, Washington, United States
Clinical Trial Site
Seattle, Washington, United States
Clinical Trial Site
Vancouver, Washington, United States
Clinical Trial Site
Milwaukee, Wisconsin, United States
Clinical Trial Site
Sydney, New South Wales, Australia
Clinical Trial Site
Waratah, New South Wales, Australia
Clinical Trial Site
South Brisbane, Queensland, Australia
Clinical Trial Site
Adelaide, South Australia, Australia
Clinical Trial Site
Clayton, Victoria, Australia
Clinical Trial Site
Geelong, Victoria, Australia
Clinical Trial Site
Heidelberg, Victoria, Australia
Clinical Trial Site
Nedlands, Western Australia, Australia
Clinical Trial Site
Krems, Lower Austria, Austria
Clinical Trial Site
Salzburg, State of Salzburg, Austria
Clinical Trial Site
Linz, Upper Austria, Austria
Clinical Trial Site
Wels, Upper Austria, Austria
Clinical Trial Site
Brussels, Brussels Capital, Belgium
Clinical Trial Site
Woluwe-Saint-Lambert, Brussels Capital, Belgium
Clinical Trial Site
Kortrijk, Flanders, Belgium
Clinical Trial Site
Liège, Liège Province, Belgium
Clinical Trial Site
Charleroi, Wallonia, Belgium
Clinical Trial Site
Toronto, Ontario, Canada
Clinical Trial Site
Greenfield Park, Quebec, Canada
Clinical Trial Site
Hořovice, Central Bohemia, Czechia
Clinical Trial Site
Liberec, Liberec Region, Czechia
Clinical Trial Site
Olomouc, Olomouc Region, Czechia
Clinical Trial Site
Prague, Prague, Czechia
Clinical Trial Site
Zlín, Zlín, Czechia
Clinical Trial Site
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Clinical Trial Site
Brest, Brittany Region, France
Clinical Trial Site
Plérin, Brittany Region, France
Clinical Trial Site
Besançon, Doubs, France
Clinical Trial Site
Montpellier, Hérault, France
Clinical Trial Site
Toulouse, Occitanie, France
Clinical Trial Site
Marseille, Provence-Alpes-Côte d'Azur Region, France
Clinical Trial Site
Bobigny, France
Clinical Trial Site
Villejuif, Île-de-France Region, France
Clinical Trial Site
Frankfurt, Hassen, Germany
Clinical Trial Site
Düsseldorf, North Rhine-Westphalia, Germany
Clinical Trial Site
Witten, North Rhine-Westphalia, Germany
Clinical Trial Site
Torgau, Saxony, Germany
Clinical Trial Site
Pátrai, Achaia, Greece