OP-1250 (Palazestrant) vs. Standard of Care for the 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 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
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Glendale, United States
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La Jolla, United States
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Los Alamitos, United States
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Los Angeles, United States
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Whittier, United States
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Aurora, United States
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Denver, United States
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Golden, United States
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Grand Junction, United States
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Danbury, United States
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Newark, United States
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Jacksonville, United States
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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
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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
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Farmington, United States
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New York, United States
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Port Jefferson Station, United States
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Dayton, United States
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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
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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
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Edegem, Belgium
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Wilrijk, Belgium
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Woluwe-Saint-Lambert, Belgium
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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
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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
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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
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León, Spain
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Lleida, Spain
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Madrid, Spain
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Pamplona, Spain
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Seville, Spain
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Reus, Spain
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Valencia, Spain
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Alicante, Spain
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Barcelona, Spain
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Fuenlabrada, Spain
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Madrid, Spain
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Murcia, Spain
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Santa Cruz de Tenerife, Spain
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Santiago de Compostela, Spain
Clinical Trial Site
Changhua, Taiwan
Clinical Trial Site
Kaohsiung City, Taiwan
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Taichung, Taiwan
Clinical Trial Site
Taichung, Taiwan
Clinical Trial Site
Tainan, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Bangkok, Thailand
Clinical Trial Site
Bangkok, Thailand
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Bangkok, Thailand
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Chiang Mai, Thailand
Clinical Trial Site
Samut Sakhon, Thailand
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Songkhla, Thailand
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Leicester, United Kingdom
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Nottingham, United Kingdom
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Taunton, United Kingdom
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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.