OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
NCT ID: NCT06016738
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
510 participants
INTERVENTIONAL
2023-11-16
2027-09-30
Brief Summary
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Detailed Description
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This trial is seeking adult participants with ER+, HER2- advanced or metastatic breast cancer whose disease has relapsed or progressed on 1 or 2 prior lines of standard-of-care endocrine therapy for metastatic breast cancer. Prior lines of therapy must include one line of endocrine therapy in combination with a CDK 4/6 inhibitor. In the dose-selection part of the trial, approximately 120 participants will be randomized to one of the two doses of palazestrant or to the standard-of-care endocrine therapy. Thereafter, approximately 390 participants will be randomized to palazestrant at the selected dose or to the standard-of-care endocrine therapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Palazestrant (OP-1250)
Participants will receive Palazestrant
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.
Standard of Care Endocrine Therapy
Participants will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.
* Evaluable disease (measurable disease or bone-only disease).
* Previously received a CDK4/6 inhibitor in combination with an endocrine therapy in the advanced setting. One additional line of ET as a monotherapy is allowed. Duration of the most recent prior ET must be at least 6 months.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate hematologic, hepatic, and renal functions.
* Female participants can be pre-, peri- or postmenopausal.
* Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.
Exclusion Criteria
* Previously received chemotherapy in the advanced/metastatic setting.
* Previously received treatment with elacestrant or an investigational estrogen receptor-directed therapy.
* History of allergic reactions to study treatment.
* Any contraindications to the selected standard-of-care endocrine therapy in the local prescribing information.
* Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.
* Clinically significant comorbidities such as significant cardiac or cerebrovascular disease, gastrointestinal disorders that could affect absorption of study treatment.
18 Years
ALL
No
Sponsors
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Olema Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director, MD
Role: STUDY_DIRECTOR
Olema Pharmaceuticals, Inc.
Locations
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Clinical Trial Site
Tucson, Arizona, United States
Clinical Trial Site
Fountain Valley, California, United States
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La Jolla, 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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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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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, 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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Edegem, 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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Belo Horizonte, Minas Gerais, 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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Itajaí, Santa Catarina, Brazil
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Sorocaba, São Paulo, 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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Bourg-en-Bresse, Ain, France
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Besançon, Doubs, 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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Montpellier, , 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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Central, 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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Alessandria, Piedmont, 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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Zapopan, Jalisco, 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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Skórzewo, Greater Poland Voivodeship, Poland
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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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Krakow, , 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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Matosinhos Municipality, Porto District, Portugal
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Porto, 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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Craiova, Dolj, Romania
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Iași, Iaşi, Romania
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Timișoara, Timiș County, 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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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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Valencia, Valencia, Spain
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Alicante, , Spain
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Madrid, , 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 City, , 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
Clinical Trial Site
Taunton, Somerset, United Kingdom
Clinical Trial Site
Bodelwyddan, , United Kingdom
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London, , United Kingdom
Countries
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Central Contacts
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Related Links
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Olema Publications
Other Identifiers
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OPERA-01
Identifier Type: OTHER
Identifier Source: secondary_id
OP-1250-301
Identifier Type: -
Identifier Source: org_study_id
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