RecruitingPhase III🇵🇱 PolandEN original

OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

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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 safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Dorosłe kobiety lub mężczyźni
  • Rak piersi zaawansowany, który nie może być wyleczony operacyjnie lub lekami
  • Chorobę dającą się zmierzyć w badaniach obrazowych lub chorobę tylko w kościach
  • Wcześniejsze leczenie inhibitorem CDK4/6 w połączeniu z terapią hormonalną, ostatnie leczenie hormonalne trwało co najmniej 6 miesięcy
  • Dobry stan ogólny (ECOG 0 lub 1)
  • Prawidłowe wyniki badań krwi, wątroby i nerek
  • Kobiety mogą być w każdym okresie menopauzalnym
  • Mężczyźni i młodsze kobiety muszą zgodzić się na wstrzykiwanie hormonu GnRH

✗ Disqualifies

  • Przerzuty w narządach wewnętrznych zagrażające funkcji organizmu lub inne powody uniemożliwiające hormonalne leczenie
  • Wcześniejsza chemioterapia w zaawansowanym lub przerzutowym stadium choroby
  • Wcześniejsze leczenie elacestranem lub inną eksperymentalną terapią skierowaną na receptor estrogenowy
  • Alergia na leki stosowane w badaniu
  • Przeciwwskazania do wybranego standardowego leczenia hormonalnego
  • Przerzuty do mózgu, zapalenie opon mózgowych lub ucisk na rdzeń kręgowy wymagające natychmiastowego leczenia
  • Poważne choroby współistniejące serca, mózgu lub zaburzenia żołądkowo-jelitowe wpływające na wchłanianie leków

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
March 13, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (233)

Clinical Trial Site

Tucson, United States

Clinical Trial Site

Fountain Valley, United States

Clinical Trial Site

Glendale, United States

Clinical Trial Site

La Jolla, United States

Clinical Trial Site

Los Alamitos, United States

Clinical Trial Site

Los Angeles, United States

Clinical Trial Site

Whittier, United States

Clinical Trial Site

Aurora, United States

Clinical Trial Site

Denver, United States

Clinical Trial Site

Golden, United States

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Grand Junction, United States

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Danbury, United States

Clinical Trial Site

Newark, United States

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Jacksonville, United States

Clinical Trial Site

Margate, United States

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Orlando, United States

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Plantation, United States

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Tamarac, United States

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Atlanta, United States

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Chicago, United States

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Chicago, United States

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Urbana, United States

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Baton Rouge, United States

Clinical Trial Site

New Orleans, United States

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Baltimore, United States

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Boston, United States

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Detroit, United States

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Saint Louis Park, United States

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Woodbury, United States

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Lincoln, United States

Clinical Trial Site

Farmington, United States

Clinical Trial Site

New York, United States

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Port Jefferson Station, United States

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Dayton, United States

Clinical Trial Site

Toledo, United States

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Portland, United States

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Sayre, United States

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Nashville, United States

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Nashville, United States

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Nashville, United States

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Dallas, United States

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Dallas, United States

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Houston, United States

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Webster, United States

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Ogden, United States

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Spokane, United States

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Spokane, United States

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Bahía Blanca, Argentina

Clinical Trial Site

Mar del Plata, Argentina

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Mar del Plata, Argentina

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Córdoba, Argentina

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Córdoba, Argentina

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San Salvador de Jujuy, Argentina

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La Rioja, Argentina

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Viedma, Argentina

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Rosario, Argentina

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Rosario, Argentina

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San Miguel de Tucumán, Argentina

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Buenos Aires, Argentina

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Gosford, Australia

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Westmead, Australia

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Adelaide, Australia

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Ballarat Central, Australia

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Clayton, Australia

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Shepparton, Australia

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Nedlands, Australia

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Wels, Austria

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Wiener Neustadt, Austria

Clinical Trial Site

Edegem, Belgium

Clinical Trial Site

Wilrijk, Belgium

Clinical Trial Site

Woluwe-Saint-Lambert, Belgium

Clinical Trial Site

Charleroi, Belgium

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Leuven, Belgium

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Salvador, Brazil

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Brasília, Brazil

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São Luís, Brazil

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Belo Horizonte, Brazil

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Curitiba, Brazil

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Recife, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

Clinical Trial Site

Itajaí, Brazil

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Jaú, Brazil

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Sorocaba, Brazil

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Porto Alegre, Brazil

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Rio de Janeiro, Brazil

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Panagyurishte, Bulgaria

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Sofia, Bulgaria

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Vratsa, Bulgaria

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Calgary, Canada

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London, Canada

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Toronto, Canada

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Montreal, Canada

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Hradec Králové, Czechia

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Nový Jičín, Czechia

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Olomouc, Czechia

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Brno, Czechia

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Prague, Czechia

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Bourg-en-Bresse, France

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Besançon, France

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Nantes, France

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Nantes, France

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Compiègne, France

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Clermont-Ferrand, France

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Le Mans, France

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Villejuif, France

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Caen, France

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Montpellier, France

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Paris, France

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Karlsruhe, Germany

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Krefeld, Germany

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Velbert, Germany

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Dresden, Germany

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Kiel, Germany

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Central, Hong Kong

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Hong Kong, Hong Kong

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Kowloon, Hong Kong

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Hong Kong, Hong Kong

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Hong Kong, Hong Kong

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Pécs, Hungary

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Kecskemét, Hungary

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Debrecen, Hungary

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Avellino, Italy

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Bologna, Italy

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Meldola, Italy

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Modena, Italy

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Reggio Emilia, Italy

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Udine, Italy

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Rome, Italy

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Rome, Italy

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Milan, Italy

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Rozzano, Italy

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Piacenza, Italy

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Alessandria, Italy

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Aviano, Italy

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Ancona, Italy

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Genova, Italy

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Naples, Italy

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Padova, Italy

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Pavia, Italy

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Sungai Petani, Malaysia

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Kota Bharu, Malaysia

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Ipoh, Malaysia

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George Town, Malaysia

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Putrajaya, Malaysia

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Kuching, Malaysia

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Petaling Jaya, Malaysia

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Kuala Lumpur, Malaysia

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Guadalajara, Mexico

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Mexico City, Mexico

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Puebla City, Mexico

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San Luis Potosí City, Mexico

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Monterrey, Mexico

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Oaxaca City, Mexico

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Sinaloa, Mexico

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Amsterdam, Netherlands

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Rotterdam, Netherlands

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Lublin, Poland

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Lodz, Poland

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Otwock, Poland

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Brzozów, Poland

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Rzeszów, Poland

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Gdynia, Poland

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Gdansk, Poland

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Krakow, Poland

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Krakow, Poland

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Poznan, Poland

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Wroclaw, Poland

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Coimbra, Portugal

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Lisbon, Portugal

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Lisbon, Portugal

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Porto, Portugal

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Senhora da Hora, Portugal

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Mayagüez, Puerto Rico

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Oradea, Romania

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Brasov, Romania

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Bucharest, Romania

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Cluj-Napoca, Romania

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Cluj-Napoca, Romania

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Craiova, Romania

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Iași, Romania

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Timișoara, Romania

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Bucharest, Romania

Clinical Trial Site

Iași, Romania

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Suwon, South Korea

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Busan, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Suwon, South Korea

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Badajoz, Spain

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Badalona, Spain

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Manresa, Spain

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Girona, Spain

Clinical Trial Site

León, Spain

Clinical Trial Site

Lleida, Spain

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Madrid, Spain

Clinical Trial Site

Pamplona, Spain

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Seville, Spain

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Reus, Spain

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Valencia, Spain

Clinical Trial Site

Alicante, Spain

Clinical Trial Site

Barcelona, Spain

Clinical Trial Site

Fuenlabrada, Spain

Clinical Trial Site

Madrid, Spain

Clinical Trial Site

Murcia, Spain

Clinical Trial site

Santa Cruz de Tenerife, Spain

Clinical Trial Site

Santiago de Compostela, Spain

Clinical Trial Site

Changhua, Taiwan

Clinical Trial Site

Kaohsiung City, Taiwan

Clinical Trial Site

Taichung, Taiwan

Clinical Trial Site

Taichung, Taiwan

Clinical Trial Site

Tainan, 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

Bangkok, Thailand

Clinical Trial Site

Bangkok, Thailand

Clinical Trial Site

Chiang Mai, Thailand

Clinical Trial Site

Samut Sakhon, Thailand

Clinical Trial Site

Songkhla, Thailand

Clinical Trial Site

Leicester, United Kingdom

Clinical Trial Site

Nottingham, United Kingdom

Clinical Trial Site

Taunton, United Kingdom

Clinical Trial Site

Bodelwyddan, United Kingdom

Clinical Trial Site

London, 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.