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
2026-05-15
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 (124)
Clinical Trial Site
Hot Springs, Arkansas, United States
Clinical Trial Site
Beverly Hills, California, United States
Clinical Trial Site
Santa Barbara, California, United States
Clinical Trial Site
Aurora, Colorado, United States
Clinical Trial Site
Denver, Colorado, United States
Clinical Trial Site
Honolulu, Hawaii, United States
Clinical Trial Site
Peoria, 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
Minneapolis, Minnesota, United States
Clinical Trial Site
Kansas City, Missouri, United States
Clinical Trial Site
Santa Fe, New Mexico, United States
Clinical Trial Site
Cincinnati, Ohio, United States
Clinical Trial Site
Columbus, Ohio, United States
Clinical Trial Site
Horsham, Pennsylvania, United States
Clinical Trial Site
Sayre, Pennsylvania, United States
Clinical Trial Site
Knoxville, Tennessee, United States
Clinical Trial Site
Tennessee City, Tennessee, 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
Norfolk, Virginia, United States
Clinical Trial Site
Olympia, Washington, United States
Clinical Trial Site
Vancouver, Washington, 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
Linz, Upper Austria, Austria
Clinical Trial Site
Kortrijk, Flanders, Belgium
Clinical Trial Site
Charleroi, Wallonia, Belgium
Clinical Trial Site
Toronto, Ontario, Canada
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
Besançon, Doubs, France
Clinical Trial Site
Montpellier, Hérault, France
Clinical Trial Site
Toulouse, Occitanie, France
Clinical Trial Site
Bobigny, France
Clinical Trial Site
Torgau, Saxony, Germany
Clinical Trial Site
Athens, Pireas, Greece
Clinical Trial Site
Thessaloniki, Thessaloniki, Greece
Clinical Trial Site
Hong Kong, Hong Kong, Hong Kong
Clinical Trial Site
Hong Kong, Kowloon, Hong Kong
Clinical Trial Site
Hong Kong, Pok Fu Lam, Hong Kong
Clinical Trial Site
Kecskemét, Bács-Kiskun county, Hungary
Clinical Trial Site
Debrecen, Hajdú-Bihar, Hungary
Clinical Trial Site
Bologna, Emilia-Romagna, Italy
Clinical Trial Site
Genoa, Liguria, Italy
Clinical Trial Site
Milan, Milano, Italy
Clinical Trial Site
Prato, Tuscany, Italy
Clinical Trial Site
Milan, Varese, Italy
Clinical Trial Site
Ipoh, Ipoh Perak, Malaysia
Clinical Trial Site
Kuala Lumpur, Kuala Lumpur, Malaysia
Clinical Trial Site
Kuala Lumpur, Kuala Lumpur, Malaysia
Clinical Trial Site
George Town, Pulau Pinang, Malaysia
Clinical Trial Site
Kota Kinabalu, Sabah, Malaysia
Clinical Trial Site
Kuching, Sarawak, Malaysia
Clinical Trial Site
Petaling Jaya, Selangor, Malaysia
Clinical Trial Site
Putrajaya, Wilayah PE, Malaysia
Clinical Trial Site
Apeldoorn, Gelderland, Netherlands
Clinical Trial Site
Amsterdam, North Holland, Netherlands
Clinical Trial Site
Rzeszów, Podkarpackie Voivodeship, Poland
Clinical Trial Site
Rzeszów, Podkarpackie Voivodeship, Poland
Clinical Trial Site
Brzozów, Woj Podkarpackie, Poland
Clinical Trial Site
Lodz, Łódź Voivodeship, Poland
Clinical Trial Site
Porto, Porto District, Portugal
Clinical Trial Site
Bucharest, Bucharest, Romania
Clinical Trial Site
Cluj-Napoca, Cluj, Romania
Clinical Trial Site
Ovidiu, Constanța County, Romania
Clinical Trial Site
Craiova, Dolj, Romania
Clinical Trial Site
Iași, Iaşi, Romania
Clinical Trial Site
Timișoara, Timiș County, Romania
Clinical Trial Site
Busan, Busan Metropolitan City, South Korea
Clinical Trial Site
Daegu, Daegu Metropolitan City, South Korea
Clinical Trial Site
Goyang-si, Gyeonggi-do, South Korea
Clinical Trial Site
Seongnam-si, Gyeonggi-do, South Korea
Clinical Trial Site
Suwon, Gyeonggi-do, South Korea
Clinical Trial Site
Yongin-si, Gyeonggi-do, South Korea
Clinical Trial Site
Seoul, Seoul, South Korea
Clinical Trial Site 1
Seoul, Seoul, South Korea
Clinical Trial Site 2
Seoul, Seoul, South Korea
Clinical Trial Site
Seoul, Seoul, South Korea
Clinical Trial Site
Seoul, Seoul Special City, South Korea
Clinical Trial Site
Seoul, Seoul Special City, South Korea
Clinical Trial Site
Alicante, Alicante, Spain
Clinical Trial Site
Barcelona, Barcelona, Spain
Clinical Trial Site
Barcelona, Barcelona, Spain
Clinical Trial Site
Barcelona, Barcelona, Spain
Clinical Trial Site
Granada, Granada, Spain
Clinical Trial Site
Lleida, Lleida, Spain
Clinical Trial Site
Madrid, Madrid, Spain
Clinical Trial Site
Madrid, Madrid, Spain
Clinical Trial Site
Madrid, Madrid, Spain
Clinical Trial Site
Madrid, Madrid, Spain
Clinical Trial Site
Murcia, Murcia, Spain
Clinical Trial Site
Seville, Sevilla, Spain
Clinical Trial Site
Valencia, Valencia, Spain
Clinical Trial Site
Zaragoza, Zaragoza, Spain
Clinical Trial Site
Chang-hua, Chang Hua, Taiwan
Clinical Trial Site
Kaohsiung City, Sanmin, Taiwan
Clinical Trial Site
Taipei, Special Municipality, Taiwan
Clinical Trial Site
Taipei, Special Municipality, Taiwan
Clinical Trial Site
Taipei, Taipei City, Taiwan
Clinical Trial Site
Taipei, Taipei City, Taiwan
Clinical Trial Site
Bangkok, Bangkok, Thailand
Clinical Trial Site
Dusit, Bangkok, Thailand
Clinical Trial Site
Ban Phaeo, Changwat Samut Sakhon, Thailand
Clinical Trial Site
Hat Yai, Changwat Songkhla, Thailand
Clinical Trial Site
Chiang Mai, Chiang Mai, Thailand
Clinical Trial Site
Brighton, England, United Kingdom
Clinical Trial Site
London, England, United Kingdom
Clinical Trial Site
London, Greater London, United Kingdom
Clinical Trial Site
Taunton, Somerset, United Kingdom
Clinical Trial Site
Guildford, Surrey, United Kingdom