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 (TROPION-Breast05)
Start Date
11/23/2023
Completion Date
9/30/2030
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.
Detailed Description
The primary objective of the study is to demonstrate superiority of Dato-DXd + durvalumab relative to ICC + pembrolizumab by assessment of PFS as assessed by BICR in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC. The study will be stratified based on geographic location (US/Canada/Europe vs. Dato-DXd monotherapy enrolling countries vs. rest of world), disease-free interval (DFI) history (de novo vs. prior DFI 6 to 12 months vs. prior DFI \> 12 months), and prior PD-1/PD-L1 treatment for early stage TNBC (yes vs. no). This study aims to see if Dato-DXd with durvalumab allows patients to live longer without their breast cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy and pembrolizumab. This study is also looking to see how the treatment and the breast cancer affects patients' quality of life.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Dato-DXd
Durvalumab
Paclitaxel
Nab-paclitaxel
Gemcitabine
Carboplatin
Pembrolizumab
Conditions
Locations
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Daphne, Alabama 36526
United States
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Springdale, Arkansas 72762
United States
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Duarte, California 91010
United States
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Glendale, California 91204
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Sacramento, California 95817
United States
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Santa Rosa, California 95403
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Aurora, Colorado 80012
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New Haven, Connecticut 06510
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Jacksonville, Florida 32256
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Miami, Florida 33176
United States
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Palm Bay, Florida 32909
United States
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Plantation, Florida 33324
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Atlanta, Georgia 30318
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Honolulu, Hawaii 96819
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Chicago, Illinois 60637
United States
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Decatur, Illinois 62526
United States
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Elmhurst, Illinois 60126
United States
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Naperville, Illinois 60540
United States
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New Albany, Indiana 47150
United States
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Des Moines, Iowa 50309
United States
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Lexington, Kentucky 40503
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Louisville, Kentucky 40202
United States
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Louisville, Kentucky 40207
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Baton Rouge, Louisiana 70808
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Baton Rouge, Louisiana 70809
United States
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Baltimore, Maryland 21215
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Columbia, Maryland 21044
United States
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Boston, Massachusetts 02111
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Worcester, Massachusetts 01655
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Detroit, Michigan 48201
United States
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Grand Rapids, Michigan 49503
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Saint Paul, Minnesota 55109
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Hattiesburg, Mississippi 39401
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St Louis, Missouri 63129
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Albuquerque, New Mexico 87109
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Albany, New York 12206
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New York, New York 10065
United States
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Stony Brook, New York 11794-7263
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Cincinnati, Ohio 45219
United States
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Cincinnati, Ohio 45245
United States
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Cleveland, Ohio 44195
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York, Pennsylvania 17403
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Providence, Rhode Island 02903
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Chattanooga, Tennessee 37404
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Nashville, Tennessee 37203
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Dallas, Texas 75230
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Dallas, Texas 75246
United States
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Dallas, Texas 75246
United States
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El Paso, Texas 79902
United States
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Flower Mound, Texas 75028
United States
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Fort Worth, Texas 76104
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Houston, Texas 77054
United States
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Houston, Texas 77090
United States
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Houston, Texas 77098
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Kingwood, Texas 77339
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McKinney, Texas 75071
United States
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Sugar Land, Texas 77479
United States
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Charlottesville, Virginia 22903
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Fairfax, Virginia 22031
United States
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Midlothian, Virginia 23114
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Norfolk, Virginia 23502
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Roanoke, Virginia 24014
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Tacoma, Washington 98405
United States
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Madison, Wisconsin 53792
United States
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CABA, 1414
Argentina
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CABA, 1425
Argentina
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CABA, C1113AAE
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CABA, C1425
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Ciudad Autónoma Buenos Aires, C1430EFA
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Ciudad de Buenos Aires, C1015ABO
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Rosario, 2000
Argentina
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San Nicolás de los Arroyos, B2900
Argentina
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Camperdown, 2050
Australia
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Darlinghurst, 2010
Australia
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Heidelberg, 3084
Australia
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Melbourne, 3000
Australia
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Nedlands, 6009
Australia
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Waratah, 2298
Australia
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Barretos, 14784-400
Brazil
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Curitiba, 80730-150
Brazil
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Florianópolis, 88034-000
Brazil
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Goiânia, 74000-000
Brazil
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Itajaí, 88301-220
Brazil
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Porto Alegre, 90035-003
Brazil
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Recife, 52010-075
Brazil
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São Paulo, 01246-000
Brazil
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São Paulo, 01317-001
Brazil
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Teresina, 64049-200
Brazil
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Barrie, Ontario L4M 6M2
Canada
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Hamilton, Ontario L8V 5C2
Canada
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Toronto, Ontario M5G 2M9
Canada
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Greenfield Park, Quebec J4V 2H1
Canada
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Montreal, Quebec H2X 0A9
Canada
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Montreal, Quebec H4A 3J1
Canada
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Québec, Quebec G1S 4L8
Canada
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Regina, Saskatchewan S4T 7T1
Canada
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Saskatoon, Saskatchewan S7N 4H4
Canada
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Anyang, 455000
China
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Beijing, 100044
China
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Beijing, 100142
China
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Bengbu, 233004
China
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Changchun, 130021
China
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Changsha, 410008
China
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Changsha, 410013
China
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Chengdu, 610000
China
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Chengdu, 610041
China
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Chongqing, 400030
China
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Fuzhou, 350014
China
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Guangzhou, 510060
China
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Guangzhou, 510120
China
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Guangzhou, 510700
China
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Hangzhou, 310009
China
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Hangzhou, 310016
China
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Hangzhou, 310022
China
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Harbin, 150081
China
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Hefei, 230031
China
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Jinan, 250021
China
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Meizhou, 514031
China
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Nanchang, 330009
China
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Nanjing, 2100008
China
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Nanjing, 210009
China
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Nanning, 530021
China
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Shandong,
China
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Shanghai, 200025
China
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Shanghai, 200080
China
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Shenyang, 110004
China
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Tianjin, 300000
China
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Wenzhou, 325000
China
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Wuhan, 430022
China
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Wuhan, 430079
China
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Xi'an, 710061
China
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Xiamen, 361003
China
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Xintai, 54031
China
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Xuzhou, 221009
China
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Zhanjiang, 524003
China
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Zhengzhou, 450008
China
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Zhengzhou, 450052
China
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Lille, 59000
France
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Lyon, 69373
France
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Montpellier, 34298
France
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Paris, 75020
France
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Saint-Herblain, 44805
France
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Toulouse, 31059
France
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Vandœuvre-lès-Nancy, 54511
France
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Villejuif, 94800
France
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Düsseldorf, 40479
Germany
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Essen, 45136
Germany
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Georgsmarienhütte, 49124
Germany
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Hamburg, 20357
Germany
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Hanover, 30625
Germany
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Heidelberg, 69120
Germany
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Heilbronn, 74078
Germany
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Leipzig, 04103
Germany
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Hong Kong, 999077
Hong Kong
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Hong Kong, 999077
Hong Kong
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Hong Kong,
Hong Kong
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Shatin, 00000
Hong Kong
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Calicut, 673601
India
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Chennai, 600031
India
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Jaipur, 302004
India
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Kochi, 682027
India
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Kolkata, 700160
India
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Kottayam, 686008
India
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Marg Jaipur, 302004
India
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Mohali, 160055
India
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Mysuru, 570017
India
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Nagpur, 440001
India
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Nashik, 422009
India
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New Delhi, 110075
India
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New Delhi, 11029
India
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Puducherry, 605006
India
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Surat, 395002
India
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Thiruvananthapuram, 695011
India
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Vadodara, 391760
India
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Visakhapatnam, 530053
India
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Bergamo, 24127
Italy
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Empoli, 50053
Italy
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Milan, 20132
Italy
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Milan, 20141
Italy
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Modena, 41124
Italy
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Naples, 80131
Italy
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Padova, 35128
Italy
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Reggio Emilia, 42123
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Roma, 00168
Italy
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Rozzano, 20089
Italy
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Akashi-shi, 673-8558
Japan
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Bunkyō City, 113-8431
Japan
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Bunkyō City, 113-8677
Japan
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Chiba, 260-8717
Japan
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Chūōku, 104-0045
Japan
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Fukuoka, 811-1395
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Fukushima, 960-1295
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Gifu, 501-1194
Japan
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Hidaka-shi, 350-1298
Japan
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Hiroshima, 730-8518
Japan
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Hiroshima, 734-8551
Japan
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Isehara-shi, 259-1193
Japan
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Kamogawa-shi, 296-8602
Japan
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Kashiwa, 277-8577
Japan
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Kitaadachi-gun, 362-0806
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Kōtoku, 135-8550
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Kumamoto, 860-8556
Japan
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Kurume-shi, 830-0011
Japan
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Matsuyama, 791-0280
Japan
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Nagoya, 466-8560
Japan
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Nagoya, 467-8602
Japan
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Niigata, 951-8566
Japan
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Nishinomiya-shi, 663-8501
Japan
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Okayama, 700-8558
Japan
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Osaka, 541-8567
Japan
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Osakasayama-shi, 589-8511
Japan
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Ota-shi, 373-8550
Japan
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Sapporo, 003-0804
Japan
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Sendai, 980-8574
Japan
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Shinagawa-ku, 142-8666
Japan
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Shinjuku-ku, 160-0023
Japan
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Shinjuku-ku, 162-8655
Japan
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Tsu, 514-8507
Japan
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Tsukuba, 305-8577
Japan
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Yokohama, 241-8515
Japan
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CD Mexico, 04980
Mexico
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Guadalajara, 44638
Mexico
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Guadalajara, 44670
Mexico
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Mexico City, 0 3100
Mexico
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Mexico City, 06760
Mexico
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México, 04700
Mexico
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Tuxtla Gutiérrez, 29090
Mexico
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Bacolod, 6100
Philippines
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Cebu City, 6000
Philippines
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City of Muntinlupa, 1780
Philippines
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Manila, 1000
Philippines
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Quezon City, 1112
Philippines
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San Juan City, 1502
Philippines
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Bialystok, 15-027
Poland
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Bydgoszcz, 85-796
Poland
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Gdansk, 80-952
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Gdynia, 81-519
Poland
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Konin, 62-500
Poland
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Krakow, 31-115
Poland
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Krakow, 31-501
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Legnica, 59-220
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Lodz, 90-302
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Lublin, 20-090
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Przemyśl, 37-700
Poland
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Warsaw, 02-781
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Wroclaw, 53-413
Poland
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Singapore, 119228
Singapore
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Singapore, 169610
Singapore
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Singapore, 217562
Singapore
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Singapore, 308433
Singapore
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Cape Town, 7570
South Africa
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Johannesburg, 2013
South Africa
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Johannesburg, 2193
South Africa
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Johannesburg, 2196
South Africa
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Paarl, 7646
South Africa
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Pretoria, 0081
South Africa
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Pretoria, 0081
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Busan, 49241
South Korea
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Daegu, 41404
South Korea
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Goyang-si, 10408
South Korea
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Seongnam-si, 13620
South Korea
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Seoul, 02841
South Korea
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Seoul, 03080
South Korea
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Seoul, 03722
South Korea
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Seoul, 05505
South Korea
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Seoul, 06273
South Korea
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Seoul, 06351
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Seoul, 06591
South Korea
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Barcelona, 08028
Spain
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Barcelona, 8035
Spain
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Granada, 18016
Spain
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Hospitalet deLlobregat, 08907
Spain
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Madrid, 28007
Spain
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Madrid, 28034
Spain
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Pamplona, 31008
Spain
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Santander, 39008
Spain
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Hsinchu, 300
Taiwan
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Kaohsiung City, 80756
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Taichung, 40447
Taiwan
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Tainan, 704
Taiwan
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Taipei, 100
Taiwan
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Taipei, 10449
Taiwan
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Taipei, 11259
Taiwan
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Taipei, 112
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Taoyuan, 333
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Bangkok, 10210
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Bangkok, 10330
Thailand
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Bangkok, 10400
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Bangkok, 10700
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Chiang Mai, 50200
Thailand
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Dusit, 10300
Thailand
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Khon Kaen, 40002
Thailand
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Songkhla, 90110
Thailand
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Ankara, 06520
Turkey (Türkiye)
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Ankara, 6200
Turkey (Türkiye)
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Besevler Ankara,
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Istanbul, 34010
Turkey (Türkiye)
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Izmir, 35575
Turkey (Türkiye)
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Küçükçekmece, 34295
Turkey (Türkiye)
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Samsun, 55200
Turkey (Türkiye)
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Cardiff, CF14 2TL
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Chelsea, SW3 6JJ
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Leicester, Le5 4PW
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Liverpool, L7 8YA
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London, EC1A 7BE
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London, SW17 0QT
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Oxford, OX3 7LE
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Surrey, GU2 7XX
United Kingdom
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Sutton, SM2 5PT
United Kingdom
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Taunton, TA1 5DA
United Kingdom
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Da Nang, 550000
Vietnam
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Hanoi, 100000
Vietnam
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Ho Chi Minh City, 700000
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Hồ Chí Minh, 700000
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Huế, 530000
Vietnam
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Viet Tri, 35000
Vietnam
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Vinh, 460000
Vietnam