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Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)
Sponsor: AstraZeneca
Summary
A Phase Ib/III Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)
Official title: A Phase Ib/III, Open-label, Randomised Study of Capivasertib Plus CDK4/6 Inhibitors and Fulvestrant Versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
895
Start Date
2021-05-10
Completion Date
2029-08-14
Last Updated
2026-03-12
Healthy Volunteers
No
Interventions
Capivasertib
Phase Ib: Capivasertib 320 mg/ 400 mg administered PO BD 4 days on /3 days off per week for 4 weeks (28 days cycle) Phase III: : Capivasertib, administered PO BD 4 days on / 3 days off per week for 4 weeks (28 days cycle) at the dose confirmed in the phase Ib portion
Fulvestrant
Phase Ib and Phase III: 500 mg (2 injections of 250 mg) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter
Palbociclib
Phase Ib: 100 mg/ 125 mg. Once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete 28-day cycle Phase III: Administered once daily for 21 days of 28-day cycle, at the dose of 125 mg.
Ribociclib
Phase Ib: 200 mg/ 400 mg/ 600 mg. Once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete 28-day cycle Phase III: Administered once daily for 21 days of 28-day cycle, at the dose confirmed in the phase 1b portion.
Abemaciclib
Phase Ib: 50 mg/ 100 mg/ 150 mg. Twice daily for 28 consecutive days to comprise a complete 28-day cycle
Locations (283)
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Tucson, Arizona, United States
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Fountain Valley, California, United States
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Glendale, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Napa, California, United States
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Newport Beach, California, United States
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San Francisco, California, United States
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Santa Barbara, 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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Newark, Delaware, United States
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Quincy, Illinois, United States
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Fort Wayne, Indiana, 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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Covington, Louisiana, United States
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Annapolis, Maryland, United States
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Baltimore, Maryland, 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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Grand Rapids, Michigan, United States
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Hannibal, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Camden, New Jersey, United States
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Brooklyn, New York, United States
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Mineola, New York, United States
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New York, New York, United States
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New York, New York, United States
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Durham, North Carolina, United States
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Gresham, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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York, Pennsylvania, United States
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Providence, Rhode Island, United States
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Greenville, South Carolina, 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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Fort Worth, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Fairfax, Virginia, United States
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Falls Church, Virginia, United States
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Midlothian, Virginia, United States
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Norfolk, Virginia, United States
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Tacoma, Washington, United States
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Buenos Aires, Argentina
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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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Chivilcoy, Argentina
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Rosario, Argentina
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Santa Fe, Argentina
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Darlinghurst, Australia
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Miranda, Australia
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Nedlands, Australia
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Nedlands, Australia
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Wahroonga, Australia
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Waratah, Australia
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Brasschaat, Belgium
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Brussels, Belgium
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Edegem, Belgium
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Haine-Saint-Paul, Belgium
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Leuven, Belgium
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Alfenas, Brazil
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Blumenau, Brazil
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Natal, Brazil
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Porto Alegre, Brazil
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Porto Velho, Brazil
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São Paulo, Brazil
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Taubaté, Brazil
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Teresina, Brazil
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Vitória, Brazil
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Abbotsford British Columbia, British Columbia, Canada
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Kelowna, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Moncton, New Brunswick, Canada
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Halifax, Nova Scotia, Canada
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Brampton, Ontario, Canada
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Ottawa, Ontario, Canada
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Sault Ste. Marie, Ontario, Canada
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Toronto, Ontario, Canada
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Sherbrooke, Quebec, Canada
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Chicoutimi, Canada
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Montreal, Canada
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Beijing, China
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Beijing, 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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Chengdu, China
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Chongqing, 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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Hefei, China
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Jinan, China
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Nanchang, China
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Nanchang, 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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Shenyang, China
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Ürümqi, China
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Ürümqi, China
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Wuhan, China
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Xi'an, China
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Xi'an, China
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Xiangyang, China
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Xuzhou, China
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Zhengzhou, China
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Aalborg, Denmark
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Aarhus N, Denmark
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Hillerød, Denmark
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Odense, Denmark
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Bobigny, France
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Clermont-Ferrand, France
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Limoges, France
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Lyon, France
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Plérin, France
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Rouen, France
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Saint-Herblain, France
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Villejuif, France
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Augsburg, Germany
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Berlin, Germany
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Berlin, Germany
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Bottrop, Germany
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Dresden, Germany
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Erlangen, Germany
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Essen, Germany
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Frankfurt am Main, Germany
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Freiburg im Breisgau, Germany
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Georgsmarienhütte, Germany
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Hamburg, Germany
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Hanover, Germany
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Heilbronn, Germany
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Kiel, Germany
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Leipzig, Germany
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Mannheim, Germany
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Mönchengladbach, Germany
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Münster, Germany
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Regensburg, Germany
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Stade, Germany
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Trier, Germany
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Ulm, Germany
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Bangalore, India
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Jaipur, India
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Jaipur, India
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Mohali, India
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Mysuru, India
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Nagpur, India
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New Delhi, India
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Puducherry, India
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Varanasi, India
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Aviano, Italy
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Prato, Italy
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Rozzano, Italy
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Chiba, Japan
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Chūōku, Japan
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Chūōku, Japan
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Hidaka-shi, Japan
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Hirakata-shi, Japan
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Hiroshima, Japan
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Isehara-shi, Japan
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Kagoshima, Japan
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Kōtoku, Japan
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Kyoto, Japan
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Matsuyama, Japan
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Nagoya, Japan
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Naha, Japan
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Okayama, Japan
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Osaka, Japan
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Ota-shi, Japan
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Sapporo, Japan
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Sendai, Japan
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Suita-shi, Japan
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Takasaki-shi, Japan
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Tsu, Japan
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Yokohama, Japan
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George Town, Malaysia
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Kuala Lumpur, Malaysia
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Kuala Lumpur, Malaysia
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Kuching, Malaysia
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Pulau Pinang, Malaysia
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Bialystok, Poland
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Bydgoszcz, Poland
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Gdansk, Poland
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Koszalin, Poland
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Krakow, Poland
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Lodz, Poland
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Lodz, Poland
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Lublin, Poland
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Rzeszów, Poland
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Warsaw, Poland
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Warsaw, Poland
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Goyang-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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Barcelona, Spain
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Granada, Spain
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Lleida, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Málaga, Spain
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Pamplona, Spain
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Santiago de Compostela, Spain
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Lund, Sweden
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Solna, Sweden
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Vaxjo, Sweden
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Kaohsiung City, 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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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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Bangkok, Thailand
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Chiang Mai, Thailand
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Dusit, Thailand
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Hat Yai, Thailand
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Khon Kaen, Thailand
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Lampang, Thailand
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Ratchathewi, Thailand
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Ankara, Turkey (Türkiye)
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Antalya, Turkey (Türkiye)
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Cordaleo, Turkey (Türkiye)
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Goztepe Istanbul, Turkey (Türkiye)
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Kayseri, Turkey (Türkiye)
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Malatya, Turkey (Türkiye)
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Samsun, Turkey (Türkiye)
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Guildford, United Kingdom
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London, United Kingdom
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Londonderry, United Kingdom
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Taunton, United Kingdom
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York, United Kingdom
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Can Tho, Vietnam
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Hanoi, Vietnam
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Ho Chi Minh City, Vietnam
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Ho Chi Minh City, Vietnam
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Hồ Chí Minh, Vietnam
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Vinh, Vietnam