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RECRUITING
NCT04862663
PHASE3

Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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

DRUG

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

DRUG

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

DRUG

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.

DRUG

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.

DRUG

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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New Delhi, India

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Puducherry, India

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Vadodara, India

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Varanasi, India

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Aviano, Italy

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Bologna, Italy

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Catanzaro, Italy

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Florence, Italy

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Milan, Italy

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Milan, Italy

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Misterbianco, Italy

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Naples, Italy

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Padova, Italy

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Prato, Italy

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Reggio Emilia, Italy

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Roma, 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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Shimotsuke-shi, Japan

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Shinagawa-ku, Japan

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Shinjuku-ku, 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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Kuala Selangor, Malaysia

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Kuala Selangor, 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