Breast Cancer Clinical Trial
A Study of Imlunestrant, Investigator’s Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer
Summary
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer
Have disease that has demonstrated progression on or after an aromatase inhibitor alone or in combination with a cyclin-dependent kinase (CDK)4/6 inhibitor
-- Participants are expected to have received prior treatment with a CDK4/6 inhibitor, if this treatment is approved and can be reimbursed
Must be deemed appropriate for treatment with endocrine therapy
If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
Have RECIST evaluable disease (measurable disease and/or nonmeasurable bone-only disease)
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
Have adequate renal, hematologic, and hepatic organ function
Must be able to swallow capsules/tablets
Exclusion Criteria:
Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, or any investigational-ER-directed therapy (including SERDs and non-SERDs), any PI3K-, mTOR- or AKT- inhibitor
Have visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease.
Have symptomatic or untreated brain metastasis.
Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study
Known allergic reaction against any of the components of the study treatment
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There are 233 Locations for this study
Chandler Arizona, 85224, United States More Info
Principal Investigator
Gilbert Arizona, 85234, United States More Info
Principal Investigator
Greenbrae California, 94904, United States More Info
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Sacramento California, 95817, United States More Info
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San Diego California, 92123, United States More Info
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Greeley Colorado, 80631, United States More Info
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Lone Tree Colorado, 80124, United States More Info
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Loveland Colorado, 80538, United States More Info
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Gainesville Florida, 32610, United States More Info
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Saint Petersburg Florida, 33705, United States More Info
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Sarasota Florida, 34232, United States More Info
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West Palm Beach Florida, 33401, United States More Info
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Honolulu Hawaii, 96819, United States More Info
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Chicago Illinois, 60612, United States More Info
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Chicago Illinois, 60612, United States More Info
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Chicago Illinois, 60637, United States More Info
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Muncie Indiana, 47303, United States More Info
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Louisville Kentucky, 40202, United States More Info
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Coon Rapids Minnesota, 55433, United States More Info
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Jackson Mississippi, 39202, United States More Info
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Clifton New Jersey, 07013, United States More Info
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Ridgewood New Jersey, 07450, United States More Info
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Binghamton New York, 13905, United States More Info
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New York New York, 10032, United States More Info
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New York New York, 10065, United States More Info
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Chapel Hill North Carolina, 27599, United States More Info
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Canton Ohio, 44710, United States More Info
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Columbus Ohio, 43219, United States More Info
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Eugene Oregon, 97401, United States More Info
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Sioux Falls South Dakota, 57105, United States More Info
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Nashville Tennessee, 37203, United States More Info
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Austin Texas, 78731, United States More Info
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Carrollton Texas, 75010, United States More Info
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Dallas Texas, 75203, United States More Info
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Dallas Texas, 75230, United States More Info
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Dallas Texas, 75231, United States More Info
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Dallas Texas, 75246, United States More Info
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Denison Texas, 75020, United States More Info
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Denton Texas, 76201, United States More Info
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Fort Worth Texas, 76104, United States More Info
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Houston Texas, 77070, United States More Info
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McKinney Texas, 75071, United States More Info
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Paris Texas, 75460, United States More Info
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San Antonio Texas, 78240, United States More Info
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The Woodlands Texas, 77380, United States More Info
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The Woodlands Texas, 77380, United States More Info
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Salt Lake City Utah, 84106, United States More Info
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Burlington Vermont, 05401, United States More Info
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Salem Virginia, 24153, United States More Info
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Caba BA, C1125, Argentina More Info
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Mar del Plata Buenos Aires, 7600, Argentina More Info
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Ciudad Autonoma de Buenos Aire Ciudad Autónoma De Buenos Aire, C1119, Argentina More Info
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Viedma RÃo Negro, R8500, Argentina More Info
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Buenos Aires , 1122, Argentina More Info
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Cordoba , X5008, Argentina More Info
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San Juan , 5400, Argentina More Info
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Santiago del Estero , 4200, Argentina More Info
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Darlinghurst New South Wales, 2010, Australia More Info
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Brisbane Queensland, 4102, Australia More Info
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Adelaide South Australia, 5000, Australia More Info
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Melbourne Victoria, 3135, Australia More Info
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Graz Steiermark, 8036, Austria More Info
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Schwaz Tirol, 6130, Austria More Info
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Vienna Wien, 1090, Austria More Info
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Salzburg , 5020, Austria More Info
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Brussels Bruxelles-Capitale, Région De, 1090, Belgium More Info
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Kortrijk West-Vlaanderen, 8500, Belgium More Info
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Brussels-Capital , 1070, Belgium More Info
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Leuven , 3000, Belgium More Info
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Londrina Paraná, 86015, Brazil
Santo Andre SP, 09060, Brazil More Info
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São Paulo , 01246, Brazil More Info
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São Paulo , 01317, Brazil More Info
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São Paulo , 04014, Brazil More Info
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Bengbu Anhui, 23300, China More Info
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Beijing Beijing, 10007, China More Info
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Guangzhou Guangdong, 51140, China More Info
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Harbin Heilongjiang, 15008, China More Info
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Luoyang Henan, 47100, China More Info
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Zhengzhou Henan, 45000, China More Info
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Wuhan Hubei, 43006, China More Info
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Changde Hunan, 41500, China More Info
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ChangSha Hunan, 41000, China More Info
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Changsha Hunan, 41000, China More Info
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Nanchang Jiangxi, 33000, China More Info
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Changchun Jilin, 13000, China More Info
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Changchun Jilin, 13002, China More Info
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Nanjing Nanjing, 21002, China More Info
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Xi'an Shaanxi, 71006, China More Info
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Tianjin Tianjin, , China More Info
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Urumqi Xinjiang, 83000, China More Info
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Hangzhou Zhejiang, 31000, China More Info
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Hangzhou Zhejiang, 31001, China More Info
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Hangzhou Zhejiang, 31002, China More Info
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Ningbo Zhejiang, 31501, China More Info
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Jining , 27202, China More Info
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Praha Praha 4 - KrÄ, 14059, Czechia More Info
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Prague Praha 8, 180 8, Czechia More Info
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Praha 10 , 100 3, Czechia More Info
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Pribram , 261 0, Czechia More Info
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Strasbourg Alsace, 67033, France More Info
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Montpellier Languedoc-Roussillon, 34070, France More Info
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Vandoeuvre-lès-Nancy Lorraine, 54519, France More Info
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Bayonne Pyrénées-Atlantiques, 64109, France More Info
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La Chaussee Saint Victor , 41260, France More Info
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Le Mans , 72000, France More Info
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Saint-Cloud ÃŽle-de-France, 92210, France More Info
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Ludwigsburg Baden-Württemberg, 71640, Germany More Info
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Erlangen Bayern, 91054, Germany More Info
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München Bayern, 80336, Germany More Info
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Frankfurt Hessen, 60431, Germany More Info
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Hannover Niedersachsen, 30177, Germany More Info
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Essen Nordrhein-Westfalen, 45136, Germany More Info
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Mönchengladbach Nordrhein-Westfalen, 41061, Germany More Info
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Kiel Schleswig-Holstein, 24105, Germany More Info
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Athens AttikÃ, 115 2, Greece More Info
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Athens AttikÃ, 11528, Greece More Info
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Nea Kifissia AttikÃ, 14564, Greece More Info
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Heraklion IrakleÃo, 711 1, Greece More Info
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Thessaloniki ThessalonÃki, 546 4, Greece More Info
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Thessaloniki ThessalonÃki, 570 0, Greece More Info
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Larissa ThessalÃa, 41110, Greece More Info
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Thessaloniki , 56403, Greece More Info
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New Delhi Delhi, 11000, India More Info
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Bengaluru Karnataka, 56002, India More Info
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Thiruvananthapuram Kerala, 69501, India More Info
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Nagpur Maharashtra, 44000, India More Info
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Nashik Maharashtra, 42200, India More Info
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Pune Maharashtra, 41100, India More Info
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Pune Maharashtra, 41105, India More Info
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Hyderabad Telangana, 50008, India More Info
Principal Investigator
Naples Campania, 80100, Italy More Info
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Napoli Campania, 80131, Italy More Info
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Roma Lazio, 00168, Italy More Info
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Milan Lombardia, 20133, Italy More Info
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Firenze Toscana, 50134, Italy More Info
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Milano , 20141, Italy More Info
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Modena , 41125, Italy More Info
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Padova , 35128, Italy More Info
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Nagoya Aichi, 466-8, Japan More Info
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Matsuyama Ehime, 791-0, Japan More Info
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Kurume Fukuoka, 830-0, Japan More Info
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Ota Gunma, 373-0, Japan More Info
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Sapporo Hokkaido, 003-0, Japan More Info
Principal Investigator
Tsukuba-shi Ibaragi, 305-8, Japan More Info
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Kawasaki Kanagawa, 216-8, Japan More Info
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Yokohama Kanagawa, 241-8, Japan More Info
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Niigata-shi Niigata, 951-8, Japan More Info
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Bunkyo-ku Tokyo, 113-8, Japan More Info
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Chuo-ku Tokyo, 104-0, Japan More Info
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Shinagawa Tokyo, 142-8, Japan More Info
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Fukuoka , 811-1, Japan More Info
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Kumamoto , 862-8, Japan More Info
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Osaka , 541-8, Japan More Info
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Shizuoka , 420-0, Japan More Info
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Cheonan-si Chungcheongnam-do [Chungnam], 31151, Korea, Republic of More Info
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Namdong-gu Incheon-gwangyeoksi [Incheon], 21565, Korea, Republic of More Info
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Seoul Korea, 03722, Korea, Republic of More Info
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Suwon-si KyÇ’nggi-do, 16499, Korea, Republic of More Info
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Gyeongsan-si KyÇ’ngsangbuk-do, 42415, Korea, Republic of More Info
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Busan Pusan-KwangyÇ’kshi, 49201, Korea, Republic of More Info
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Seoul Seoul-teukbyeolsi [Seoul], 03080, Korea, Republic of More Info
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Seoul Seoul-teukbyeolsi [Seoul], 03181, Korea, Republic of More Info
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Seoul Seoul-teukbyeolsi [Seoul], 05505, Korea, Republic of More Info
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Seoul Seoul-teukbyeolsi [Seoul], 06273, Korea, Republic of More Info
Principal Investigator
Seoul Seoul-teukbyeolsi [Seoul], 06351, Korea, Republic of More Info
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Torreón Coahuila, 27010, Mexico More Info
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Mexico City Distrito Federal, 03310, Mexico More Info
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Monterrey Nuevo León, C.P. Monterrey, 64570, Mexico More Info
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Paso De Las Lomas MX, 01330, Mexico More Info
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Monterrey Nuevo León, 64320, Mexico More Info
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San Pedro Garza Garcia Nuevo León, 66278, Mexico More Info
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Chihuahua , 31203, Mexico More Info
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Oaxaca , 68000, Mexico More Info
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Puebla , 72424, Mexico More Info
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Leeuwarden Fryslân, 8934 , Netherlands More Info
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Maastricht Limburg, 6229 , Netherlands More Info
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Den Haag Zuid-Holland, 2545 , Netherlands More Info
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St. Petersburg Peterburg, 19775, Russian Federation More Info
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Volgograd Volgogradskaya Oblast', 40013, Russian Federation More Info
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Kaluga , 24800, Russian Federation More Info
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Barcelona Catalunya [Cataluña], 08041, Spain More Info
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Madrid Madrid, Comunidad De, 28034, Spain More Info
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La Laguna Santa Cruz De Tenerife, 38320, Spain
Madrid , 28040, Spain More Info
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Sevilla , 41009, Spain More Info
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Sevilla , 41013, Spain More Info
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Valencia , 46010, Spain More Info
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Valencia , 46010, Spain More Info
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Tainan City Tainan, 73657, Taiwan More Info
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Taichung , 40705, Taiwan More Info
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Taipei , 10002, Taiwan More Info
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Üsküdar / Stanbul , , Turkey More Info
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Bornova Ä°zmir, 35100, Turkey More Info
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Adana , 01250, Turkey More Info
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Ankara , 06010, Turkey More Info
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Ankara , 06800, Turkey More Info
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Ankara , , Turkey More Info
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Antalya , 07059, Turkey More Info
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Istanbul , 34214, Turkey More Info
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Istanbul , 34722, Turkey More Info
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Malatya , 44280, Turkey More Info
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Kryvyi Rih Dnipropetrovska Oblast, 50048, Ukraine More Info
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Kharkiv Kharkivska Oblast, 61070, Ukraine More Info
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Odesa Odeska Oblast, 65025, Ukraine More Info
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Vinnytsia Vinnytska Oblast, 21029, Ukraine More Info
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Lutsk Volynska Oblast, 43018, Ukraine More Info
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Uzhhorod Zakarpatska Oblast, 88000, Ukraine More Info
Principal Investigator
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