RecruitingPhase III🇵🇱 PolandEN original

Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Pacjenci dorośli (kobiety i mężczyźni).
  • Zaawansowany rak piersi (ER+/HER2-) nieuleczalny.
  • Choroba możliwa do oceny (widoczna na badaniach lub tylko zmiany w kościach).
  • Rak piersi zdiagnozowany jako zaawansowany od razu lub nawrót po co najmniej 12 miesiącach od leczenia hormonalnego.
  • Pacjenci w dobrym ogólnym stanie zdrowia (wg skali ECOG 0-1).
  • Wystarczająca ilość komórek krwi i prawidłowe wyniki badań wątroby i nerek.
  • Kobiety w każdym wieku (przed, w trakcie lub po menopauzie).
  • Mężczyźni i kobiety przed menopauzą muszą zgodzić się na dodatkowe leczenie hormonalne.

✗ Disqualifies

  • Nawrót choroby podczas leczenia hormonalnego.
  • Wcześniejsze leczenie systemowe zaawansowanego raka piersi (ER+/HER2-).
  • Wcześniejsze leczenie lekami: fulvestrant, elacestrant lub innymi eksperymentalnymi lekami hormonalnymi.
  • Uczulenie na leki badane w tym badaniu.
  • Przeciwwskazania do stosowania leków letrozol i rybociclib.
  • Aktywne przerzuty do mózgu lub rdzenia kręgowego wymagające natychmiastowego leczenia.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
June 16, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (150)

Clinical Trial Site

Hot Springs, United States

Clinical Trial Site

Beverly Hills, United States

Clinical Trial Site

San Francisco, United States

Clinical Trial Site

Santa Barbara, United States

Clinical Trial Site

Aurora, United States

Clinical Trial Site

Denver, United States

Clinical Trial Site

New Haven, United States

Clinical Trial Site

Tampa, United States

Clinical Trial Site

Marietta, United States

Clinical Trial Site

Honolulu, United States

Clinical Trial Site

Peoria, United States

Clinical Trial Site

Urbana, United States

Clinical Trial Site

Ames, United States

Clinical Trial Site

Scarborough, United States

Clinical Trial Site

Annapolis, United States

Clinical Trial Site

Minneapolis, United States

Clinical Trial Site

Kansas City, United States

Clinical Trial Site

Santa Fe, United States

Clinical Trial Site

New York, United States

Clinical Trial Site

Charlotte, United States

Clinical Trial Site

Cincinnati, United States

Clinical Trial Site

Columbus, United States

Clinical Trial Site

Horsham, United States

Clinical Trial Site

Sayre, United States

Clinical Trial Site

Bartlett, United States

Clinical Trial Site

Knoxville, United States

Clinical Trial Site

Mount Juliet, United States

Clinical Trial Site

Tennessee City, United States

Clinical Trial Site

Denton, United States

Clinical Trial Site

El Paso, United States

Clinical Trial Site

Houston, United States

Clinical Trial Site

San Antonio, United States

Clinical Trial Site

Salt Lake City, United States

Clinical Trial Site

Fort Belvoir, United States

Clinical Trial Site

Norfolk, United States

Clinical Trial Site

Olympia, United States

Clinical Trial Site

Vancouver, United States

Clinical Trial Site

Sydney, Australia

Clinical Trial Site

Waratah, Australia

Clinical Trial Site

South Brisbane, Australia

Clinical Trial Site

Adelaide, Australia

Clinical Trial Site

Clayton, Australia

Clinical Trial Site

Geelong, Australia

Clinical Trial Site

Heidelberg, Australia

Clinical Trial Site

Nedlands, Australia

Clinical Trial Site

Linz, Austria

Clinical Trial Site

Brussels, Belgium

Clinical Trial Site

Woluwe-Saint-Lambert, Belgium

Clinical Trial Site

Kortrijk, Belgium

Clinical Trial Site

Liège, Belgium

Clinical Trial Site

Charleroi, Belgium

Clinical Trial Site

Toronto, Canada

Clinical Trial Site

Hořovice, Czechia

Clinical Trial Site

Liberec, Czechia

Clinical Trial Site

Olomouc, Czechia

Clinical Trial Site

Prague, Czechia

Clinical Trial Site

Zlín, Czechia

Clinical Trial Site

Pierre-Bénite, France

Clinical Trial Site

Brest, France

Clinical Trial Site

Plérin, France

Clinical Trial Site

Besançon, France

Clinical Trial Site

Montpellier, France

Clinical Trial Site

Toulouse, France

Clinical Trial Site

Bobigny, France

Clinical Trial Site

Villejuif, France

Clinical Trial Site

Torgau, Germany

Clinical Trial Site

Pátrai, Greece

Clinical Trial Site

Athens, Greece

Clinical Trial Site

Athens, Greece

Clinical Trial Site

Thessaloniki, Greece

Clinical Trial Site

Hong Kong, Hong Kong

Clinical Trial Site

Hong Kong, Hong Kong

Clinical Trial Site

Hong Kong, Hong Kong

Clinical Trial Site

Kecskemét, Hungary

Clinical Trial Site

Debrecen, Hungary

Clinical Trial Site

Bologna, Italy

Clinical Trial Site

Rome, Italy

Clinical Trial Site

Genoa, Italy

Clinical Trial Site

Bergamo, Italy

Clinical Trial Site

Milan, Italy

Clinical Trial Site

Milan, Italy

Clinical Trial Site

Prato, Italy

Clinical Trial Site

Milan, Italy

Clinical Trial Site

Ipoh, Malaysia

Clinical Trial Site

Kuala Lumpur, Malaysia

Clinical Trial Site

Kuala Lumpur, Malaysia

Clinical Trial Site

George Town, Malaysia

Clinical Trial Site

Kota Kinabalu, Malaysia

Clinical Trial Site

Kuching, Malaysia

Clinical Trial Site

Petaling Jaya, Malaysia

Clinical Trial Site

Putrajaya, Malaysia

Clinical Trial Site

Apeldoorn, Netherlands

Clinical Trial Site

Maastricht, Netherlands

Clinical Trial Site

Amsterdam, Netherlands

Clinical Trial Site

Krakow, Poland

Clinical Trial Site

Rzeszów, Poland

Clinical Trial Site

Rzeszów, Poland

Clinical Trial Site

Brzozów, Poland

Clinical Trial Site

Lodz, Poland

Clinical Trial Site

Lisbon, Portugal

Clinical Trial Site

Porto, Portugal

Clinical Trial Site

Bucharest, Romania

Clinical Trial Site

Cluj-Napoca, Romania

Clinical Trial Site

Ovidiu, Romania

Clinical Trial Site

Craiova, Romania

Clinical Trial Site

Iași, Romania

Clinical Trial Site

Timișoara, Romania

Clinical Trial Site

Busan, South Korea

Clinical Trial Site

Daegu, South Korea

Clinical Trial Site

Goyang-si, South Korea

Clinical Trial Site

Seongnam-si, South Korea

Clinical Trial Site

Suwon, South Korea

Clinical Trial Site

Yongin-si, South Korea

Clinical Trial Site

Seoul, South Korea

Clinical Trial Site 1

Seoul, South Korea

Clinical Trial Site 2

Seoul, South Korea

Clinical Trial Site

Seoul, South Korea

Clinical Trial Site

Seoul, South Korea

Clinical Trial Site

Seoul, South Korea

Clinical Trial Site

Alicante, Spain

Clinical Trial Site

Barcelona, Spain

Clinical Trial Site

Barcelona, Spain

Clinical Trial Site

Barcelona, Spain

Clinical Trial Site

Granada, Spain

Clinical Trial Site

León, Spain

Clinical Trial Site

Lleida, Spain

Clinical Trial Site

Madrid, Spain

Clinical Trial Site

Madrid, Spain

Clinical Trial Site

Madrid, Spain

Clinical Trial Site

Madrid, Spain

Clinical Trial Site

Murcia, Spain

Clinical Trial Site

Seville, Spain

Clinical Trial Site

Valencia, Spain

Clinical Trial Site

Zaragoza, Spain

Clinical Trial Site

Chang-hua, Taiwan

Clinical Trial Site

Kaohsiung City, Taiwan

Clinical Trial Site

Taipei, Taiwan

Clinical Trial Site

Taipei, Taiwan

Clinical Trial Site

Taipei, Taiwan

Clinical Trial Site

Taipei, Taiwan

Clinical Trial Site

Bangkok, Thailand

Clinical Trial Site

Dusit, Thailand

Clinical Trial Site

Ban Phaeo, Thailand

Clinical Trial Site

Hat Yai, Thailand

Clinical Trial Site

Chiang Mai, Thailand

Clinical Trial Site

Brighton, United Kingdom

Clinical Trial Site

London, United Kingdom

Clinical Trial Site

London, United Kingdom

Clinical Trial Site

Taunton, United Kingdom

Clinical Trial Site

Guildford, United Kingdom

Trial contact

Olema Pharmaceuticals, Inc.

Contact information from ClinicalTrials.gov. Contact in English.

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.