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A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer
Sponsor: AstraZeneca
Summary
This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.
Official title: A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
625
Start Date
2023-11-23
Completion Date
2030-09-30
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
Dato-DXd
Provided in 100mg vials. IV infusion. Experimental drug.
Durvalumab
Provided in 500mg vials. IV infusion. Experimental drug.
Paclitaxel
IV infusion. Active comparator.
Nab-paclitaxel
IV infusion. Active comparator.
Gemcitabine
IV infusion. Active comparator.
Carboplatin
IV infusion. Active comparator.
Pembrolizumab
IV infusion. Active comparator.
Locations (316)
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Daphne, Alabama, United States
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Springdale, Arkansas, United States
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Duarte, California, United States
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Glendale, California, United States
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Sacramento, California, United States
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Santa Rosa, California, United States
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Aurora, Colorado, United States
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New Haven, Connecticut, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Palm Bay, Florida, United States
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Plantation, Florida, United States
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Atlanta, Georgia, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Decatur, Illinois, United States
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Elmhurst, Illinois, United States
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Naperville, Illinois, United States
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New Albany, Indiana, United States
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Des Moines, Iowa, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Baton Rouge, Louisiana, United States
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Baltimore, Maryland, United States
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Columbia, Maryland, United States
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Boston, Massachusetts, United States
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Worcester, Massachusetts, United States
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Detroit, Michigan, United States
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Grand Rapids, Michigan, United States
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Saint Paul, Minnesota, United States
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Hattiesburg, Mississippi, United States
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St Louis, Missouri, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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New York, New York, United States
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Stony Brook, New York, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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York, Pennsylvania, United States
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Providence, Rhode Island, United States
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Chattanooga, 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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Dallas, Texas, United States
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El Paso, Texas, United States
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Flower Mound, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Kingwood, Texas, United States
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McKinney, Texas, United States
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Sugar Land, Texas, United States
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Charlottesville, Virginia, United States
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Fairfax, Virginia, United States
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Midlothian, Virginia, United States
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Norfolk, Virginia, United States
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Roanoke, Virginia, United States
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Tacoma, Washington, United States
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Madison, Wisconsin, United States
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CABA, Argentina
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CABA, Argentina
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CABA, Argentina
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CABA, Argentina
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Ciudad Autónoma Buenos Aires, Argentina
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Ciudad de Buenos Aires, Argentina
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Rosario, Argentina
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San Nicolás de los Arroyos, Argentina
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Camperdown, Australia
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Darlinghurst, Australia
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Heidelberg, Australia
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Melbourne, Australia
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Nedlands, Australia
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Waratah, Australia
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Barretos, Brazil
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Curitiba, Brazil
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Florianópolis, Brazil
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Goiânia, Brazil
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Itajaí, Brazil
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Porto Alegre, Brazil
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Recife, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Teresina, Brazil
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Barrie, Ontario, Canada
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Hamilton, Ontario, Canada
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Toronto, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Regina, Saskatchewan, Canada
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Saskatoon, Saskatchewan, Canada
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Anyang, China
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Beijing, China
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Beijing, China
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Bengbu, China
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Changchun, China
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Changsha, China
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Changsha, China
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Chengdu, China
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Chengdu, China
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Chongqing, China
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Fuzhou, China
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Guangzhou, China
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Guangzhou, China
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Guangzhou, China
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Hangzhou, China
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Hangzhou, China
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Hangzhou, China
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Harbin, China
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Hefei, China
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Jinan, China
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Meizhou, China
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Nanchang, China
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Nanjing, China
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Nanjing, China
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Nanning, China
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Shandong, China
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Shanghai, China
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Shanghai, China
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Shenyang, China
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Tianjin, China
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Wenzhou, China
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Wuhan, China
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Wuhan, China
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Xi'an, China
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Xiamen, China
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Xintai, China
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Xuzhou, China
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Zhanjiang, China
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Zhengzhou, China
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Zhengzhou, China
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Lille, France
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Lyon, France
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Montpellier, France
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Paris, France
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Saint-Herblain, France
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Toulouse, France
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Vandœuvre-lès-Nancy, France
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Villejuif, France
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Düsseldorf, Germany
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Essen, Germany
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Georgsmarienhütte, Germany
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Hamburg, Germany
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Hanover, Germany
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Heidelberg, Germany
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Heilbronn, Germany
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Leipzig, Germany
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Hong Kong, Hong Kong
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Hong Kong, Hong Kong
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Hong Kong, Hong Kong
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Shatin, Hong Kong
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Calicut, India
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Chennai, India
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Jaipur, India
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Kochi, India
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Kolkata, India
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Marg Jaipur, India
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Mohali, India
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Mysuru, India
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Nagpur, India
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Nashik, India
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New Delhi, India
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New Delhi, India
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Puducherry, India
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Surat, India
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Thiruvananthapuram, India
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Vadodara, India
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Visakhapatnam, India
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Bergamo, Italy
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Empoli, Italy
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Modena, Italy
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Padova, Italy
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Rozzano, Italy
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Akashi-shi, Japan
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Bunkyō City, Japan
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Chiba, Japan
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Chūōku, Japan
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Fukuoka, Japan
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Fukushima, Japan
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Gifu, Japan
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Hidaka-shi, Japan
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Hiroshima, Japan
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Hiroshima, Japan
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Isehara-shi, Japan
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Kamogawa-shi, Japan
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Kashiwa, Japan
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Kitaadachi-gun, Japan
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Kōtoku, Japan
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Kumamoto, Japan
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Kurume-shi, Japan
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Matsuyama, Japan
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Nagoya, Japan
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Nagoya, Japan
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Niigata, Japan
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Nishinomiya-shi, Japan
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Okayama, Japan
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Osaka, Japan
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Osakasayama-shi, Japan
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Ota-shi, Japan
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Sapporo, Japan
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Sendai, Japan
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Shinagawa-ku, Japan
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Shinjuku-ku, Japan
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Shinjuku-ku, Japan
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Tsu, Japan
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Tsukuba, Japan
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Yokohama, Japan
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Guadalajara, Mexico
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Guadalajara, Mexico
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Mexico City, Mexico
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México, Mexico
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Tuxtla Gutiérrez, Mexico
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Bacolod, Philippines
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Cebu City, Philippines
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City of Muntinlupa, Philippines
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Manila, Philippines
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Quezon City, Philippines
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San Juan City, Philippines
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Bialystok, Poland
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Bydgoszcz, Poland
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Gdansk, Poland
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Gdynia, Poland
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Konin, Poland
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Krakow, Poland
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Krakow, Poland
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Legnica, Poland
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Lodz, Poland
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Lublin, Poland
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Przemyśl, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Singapore, Singapore
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Singapore, Singapore
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Singapore, Singapore
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Singapore, Singapore
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Cape Town, South Africa
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Johannesburg, South Africa
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Johannesburg, South Africa
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Johannesburg, South Africa
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Paarl, South Africa
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Pretoria, South Africa
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Pretoria, South Africa
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Busan, South Korea
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Daegu, South Korea
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Goyang-si, South Korea
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Seongnam-si, 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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Barcelona, Spain
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Barcelona, Spain
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Granada, Spain
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Hospitalet deLlobregat, Spain
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Madrid, Spain
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Madrid, Spain
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Pamplona, Spain
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Santander, Spain
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Hsinchu, Taiwan
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Kaohsiung City, 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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Taoyuan District, Taiwan
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Bangkok, Thailand
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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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Dusit, Thailand
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Khon Kaen, Thailand
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Songkhla, Thailand
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Ankara, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Besevler Ankara, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Küçükçekmece, Turkey (Türkiye)
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Samsun, Turkey (Türkiye)
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Cardiff, United Kingdom
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Chelsea, United Kingdom
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Leicester, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Oxford, United Kingdom
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Surrey, United Kingdom
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Sutton, United Kingdom
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Taunton, United Kingdom
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Da Nang, Vietnam
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Hanoi, Vietnam
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Ho Chi Minh City, Vietnam
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Hồ Chí Minh, Vietnam
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Huế, Vietnam
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Việt Trì, Vietnam
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Vinh, Vietnam