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OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
Sponsor: Olema Pharmaceuticals, Inc.
Summary
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.
Official title: A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
510
Start Date
2023-11-16
Completion Date
2027-09-30
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Palazestrant
Participants will be treated with palazestrant once daily on a 4 week (28 day) cycle. Doses evaluated in the dose-selection part will be 120 mg once daily and 90 mg once daily.
Fulvestrant
Participants will be treated with fulvestrant on C1D1, C1D15, and then on Day 1 of every subsequent 4 week (28 day) cycle
Anastrozole
Participants will be treated with anastrozole once daily on a 4 week (28 day) cycle
Letrozole
Participants will be treated with letrozole once daily on a 4 week (28 day) cycle
Exemestane
Participants will be treated with exemestane once daily on a 4 week (28 day) cycle
Locations (233)
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Tucson, Arizona, United States
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Fountain Valley, California, United States
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Glendale, California, United States
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La Jolla, California, United States
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Los Alamitos, California, United States
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Los Angeles, California, United States
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Whittier, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Golden, Colorado, United States
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Grand Junction, Colorado, United States
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Danbury, Connecticut, United States
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Newark, Delaware, United States
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Jacksonville, Florida, United States
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Margate, Florida, United States
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Orlando, Florida, United States
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Plantation, Florida, United States
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Tamarac, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Urbana, Illinois, United States
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Baton Rouge, Louisiana, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Saint Louis Park, Minnesota, United States
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Woodbury, Minnesota, United States
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Lincoln, Nebraska, United States
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Farmington, New Mexico, United States
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New York, New York, United States
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Port Jefferson Station, New York, United States
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Dayton, Ohio, United States
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Toledo, Ohio, United States
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Portland, Oregon, United States
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Sayre, Pennsylvania, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Webster, Texas, United States
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Ogden, Utah, United States
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Spokane, Washington, United States
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Spokane, Washington, United States
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Bahía Blanca, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Córdoba, Córdoba Province, Argentina
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San Salvador de Jujuy, Jujuy Province, Argentina
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La Rioja, La Rioja Province, Argentina
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Viedma, Río Negro Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Rosario, Santa Fe Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Buenos Aires, Argentina
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Gosford, New South Wales, Australia
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Westmead, New South Wales, Australia
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Adelaide, South Australia, Australia
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Ballarat Central, Victoria, Australia
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Clayton, Victoria, Australia
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Shepparton, Victoria, Australia
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Nedlands, Western Australia, Australia
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Wels, Austria
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Wiener Neustadt, Austria
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Edegem, Antwerpen, Belgium
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Wilrijk, Antwerpen, Belgium
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Woluwe-Saint-Lambert, Brussels Capital, Belgium
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Charleroi, Hainaut, Belgium
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Leuven, Vlaams Brabant, Belgium
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Salvador, Estado de Bahia, Brazil
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Brasília, Federal District, Brazil
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São Luís, Maranhão, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Curitiba, Paraná, Brazil
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Recife, Pernambuco, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Itajaí, Santa Catarina, Brazil
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Jaú, São Paulo, Brazil
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Sorocaba, São Paulo, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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Panagyurishte, Pazardzhik, Bulgaria
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Sofia, Sofia-Grad, Bulgaria
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Vratsa, Vratsa, Bulgaria
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Calgary, Alberta, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Hradec Králové, Královéhradecký kraj, Czechia
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Nový Jičín, Moravskoslezský kraj, Czechia
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Olomouc, Olomoucký kraj, Czechia
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Brno, Czechia
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Prague, Czechia
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Bourg-en-Bresse, Ain, France
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Besançon, Doubs, France
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Nantes, Loire-Atlantique, France
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Nantes, Loire-Atlantique, France
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Compiègne, Oise, France
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Clermont-Ferrand, Puy-de-Dôme, France
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Le Mans, Sarthe, France
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Villejuif, Val-de-Marne, France
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Caen, France
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Montpellier, France
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Paris, France
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Karlsruhe, Baden-Wurttemberg, Germany
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Krefeld, North Rhine-Westphalia, Germany
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Velbert, North Rhine-Westphalia, Germany
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Dresden, Saxony, Germany
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Kiel, Schleswig-Holstein, Germany
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Central, Hong Kong, Hong Kong
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Hong Kong, Hong Kong, Hong Kong
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Kowloon, Hong Kong, Hong Kong
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Hong Kong, Hong Kong
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Hong Kong, Hong Kong
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Pécs, Baranya, Hungary
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Kecskemét, Bács-Kiskun county, Hungary
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Debrecen, Hajdú-Bihar, Hungary
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Avellino, Campania, Italy
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Bologna, Emilia-Romagna, Italy
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Meldola, Emilia-Romagna, Italy
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Modena, Emilia-Romagna, Italy
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Reggio Emilia, Emilia-Romagna, Italy
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Udine, Friuli Venezia Giulia, Italy
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Rome, Lazio, Italy
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Rome, Lazio, Italy
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Milan, Lombardy, Italy
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Rozzano, Lombardy, Italy
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Piacenza, Piacenza, Italy
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Alessandria, Piedmont, Italy
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Aviano, Pordenone, 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, Kedah, Malaysia
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Kota Bharu, Kelantan, Malaysia
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Ipoh, Perak, Malaysia
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George Town, Pulau Pinang, Malaysia
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Putrajaya, Putramya, Malaysia
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Kuching, Sarawak, Malaysia
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Petaling Jaya, Selangor, Malaysia
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Kuala Lumpur, WP, Malaysia
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Puebla City, Puebla, Mexico
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San Luis Potosí City, San Luis Potosí, 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, North Holland, Netherlands
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Rotterdam, South Holland, Netherlands
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Lublin, Lublin Voivodeship, Poland
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Lodz, Lódzkie, Poland
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Otwock, Masovian Voivodeship, Poland
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Brzozów, Podkarpackie Voivodeship, Poland
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Rzeszów, Podkarpackie Voivodeship, Poland
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Gdynia, Pomeranian Voivodeship, 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, Coimbra District, Portugal
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Lisbon, Lisbon District, Portugal
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Lisbon, Lisbon District, Portugal
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Porto, Porto District, Portugal
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Senhora da Hora, Porto District, Portugal
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Mayagüez, Puerto Rico, Puerto Rico
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Oradea, Bihor County, Romania
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Brasov, Brașov County, Romania
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Bucharest, București, Romania
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Cluj-Napoca, Cluj, Romania
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Cluj-Napoca, Cluj, Romania
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Craiova, Dolj, Romania
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Iași, Iaşi, Romania
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Timișoara, Timiș County, Romania
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Bucharest, Romania
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Iași, Romania
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Suwon, Gyeonggi-do, 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, Badajoz, Spain
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Badalona, Barcelona, Spain
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Manresa, Barcelona, Spain
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Girona, Girona, Spain
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León, León, Spain
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Lleida, Lleida, Spain
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Madrid, Madrid, Spain
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Pamplona, Navarre, Spain
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Seville, Sevilla, Spain
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Reus, Tarragona, Spain
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Valencia, 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
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Changhua, Taiwan
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Taichung, Taiwan
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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
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Bangkok, Thailand
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Bangkok, Thailand
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Chiang Mai, Thailand
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Samut Sakhon, Thailand
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Songkhla, Thailand
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Leicester, Leicestershire, United Kingdom
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Nottingham, Nottingham, United Kingdom
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Taunton, Somerset, United Kingdom
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Bodelwyddan, United Kingdom
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London, United Kingdom