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ACTIVE NOT RECRUITING
NCT04494425
PHASE3

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.

Official title: A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)

Key Details

Gender

All

Age Range

18 Years - 105 Years

Study Type

INTERVENTIONAL

Enrollment

866

Start Date

2020-07-24

Completion Date

2026-06-19

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

DRUG

Trastuzumab deruxtecan

Trastuzumab deruxtecan by intravenous infusion

DRUG

Capecitabine

Investigator's choice standard of care single agent chemotherapy; capecitabine tablets will be given orally.

DRUG

Paclitaxel

Investigator's choice standard of care single agent chemotherapy; paclitaxel by intravenous infusion.

DRUG

Nab-Paclitaxel

Investigator's choice standard of care single agent chemotherapy; nab-paclitaxel by intravenous infusion

Locations (293)

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Scottsdale, Arizona, United States

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Springdale, Arkansas, United States

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Duarte, California, United States

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Los Angeles, California, United States

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Aurora, Colorado, United States

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Lakewood, Colorado, United States

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Washington D.C., District of Columbia, United States

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Jacksonville, Florida, United States

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Kansas City, Kansas, United States

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Louisville, Kentucky, United States

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Bethesda, Maryland, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Rochester, Minnesota, United States

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St Louis, Missouri, United States

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Summit, New Jersey, United States

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Westbury, New York, United States

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Columbus, Ohio, United States

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Pittsburgh, Pennsylvania, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Norfolk, Virginia, United States

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Seattle, Washington, United States

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Madison, Wisconsin, 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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Ciudad de Buenos Aires, Argentina

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Córdoba, Argentina

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La Plata, Argentina

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Mar del Plata, Argentina

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Rosario, Argentina

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Rosario, Argentina

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Adelaide, Australia

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Birtinya, Australia

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Darlinghurst, Australia

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Murdoch, Australia

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South Brisbane, Australia

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St Leonards, Australia

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Waratah, Australia

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Graz, Austria

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Innsbruck, Austria

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Anderlecht, Belgium

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Brussels, Belgium

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Charleroi, Belgium

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Edegem, Belgium

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Ghent, Belgium

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Leuven, Belgium

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Liège, Belgium

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Namur, Belgium

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Roeselare, Belgium

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Sint-Niklaas, Belgium

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Barretos, Brazil

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Belo Horizonte, Brazil

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Natal, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Rio de Janeiro, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Sorocaba, Brazil

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Toronto, CA, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Baoding, China

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Beijing, China

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Beijing, China

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Changchun, China

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Changsha, China

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Changsha, China

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Dalian, China

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Foshan, 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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Linyi, China

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Nanchang, 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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Shanghai, China

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Shenyang, China

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Tianjin, 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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Zhengzhou, China

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Aalborg, Denmark

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Copenhagen Ø, Denmark

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Odense, Denmark

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Vejle, Denmark

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Avignon, France

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Besançon, France

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Bordeaux, France

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Brest, France

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Caen, France

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Dijon, France

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Le Mans, France

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Marseille, France

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Montpellier, France

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Nice, France

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Paris, France

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Pierre-Bénite, France

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Plerin SUR MER, France

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Rennes, France

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Saint-Cloud, France

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Saint-Herblain, France

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Tours, France

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Villejuif, France

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Berlin, Germany

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Dresden, Germany

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Freiburg im Breisgau, Germany

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Hanover, Germany

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München, Germany

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München, Germany

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Münster, Germany

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Velbert, Germany

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Budapest, Hungary

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Budapest, Hungary

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Budapest, Hungary

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Győr, Hungary

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Kecskemét, Hungary

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Nyíregyháza, Hungary

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Szolnok, Hungary

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Tatabánya, Hungary

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Bengaluru, India

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Calicut, India

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Kolkata, India

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Marg Jaipur, India

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New Delhi, India

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New Delhi, India

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New Delhi, India

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New Delhi, India

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Surat, India

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Thiruvananthapuram, India

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Haifa, Israel

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Jerusalem, Israel

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Jerusalem, Israel

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Kfar Saba, Israel

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Petah Tikva, Israel

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Ramat Gan, Israel

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Tel Aviv, Israel

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Aviano, Italy

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Bergamo, Italy

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Candiolo, Italy

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Cona, Italy

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Genova, Italy

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Livorno, Italy

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Messina, Italy

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Milan, Italy

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Milan, Italy

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Naples, Italy

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Padova, Italy

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Parma, Italy

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Prato, Italy

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Tricase, Lecce, Italy

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Udine, 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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Gifu, Japan

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Hidaka-shi, Japan

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Hiroshima, Japan

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Isehara, Japan

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Kagoshima, Japan

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Kashiwa, Japan

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Kawasaki-shi, Japan

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Kitaadachi-gun, Japan

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Kōtoku, Japan

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Matsuyama, Japan

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Nagoya, Japan

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Naha, 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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Sagamihara-shi, Japan

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Sapporo, Japan

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Shinagawa-ku, Japan

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Shinjuku-ku, Japan

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Shizuoka, Japan

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Tsu, Japan

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Yokohama, Japan

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Alc. Cuauhtémoc, Mexico

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Guadalajara Jalisco, Mexico

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Guadalajra, Mexico

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Mexico City, Mexico

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Mexico City, Mexico

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Mexico City, Mexico

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México, Mexico

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Monterrey, Mexico

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Nuevo León, Mexico

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Amsterdam, Netherlands

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Breda, Netherlands

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Hengelo, Netherlands

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Leeuwarden, Netherlands

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Rotterdam, Netherlands

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Sittard-Geleen, Netherlands

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Bydgoszcz, Poland

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Koszalin, Poland

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Krakow, Poland

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Lodz, Poland

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Rzeszów, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Lisbon, Portugal

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Lisbon, Portugal

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Lisbon, Portugal

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Krasnodar, Russia

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Moscow, Russia

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Moscow, Russia

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Moscow, Russia

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Moscow, Russia

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Saint Petersburg, Russia

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Saint Petersburg, Russia

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Saint Petersburg, Russia

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Yaroslavl, Russia

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Dammam, Saudi Arabia

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Jeddah, Saudi Arabia

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Jeddah, Saudi Arabia

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Riyadh, Saudi Arabia

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Riyadh, Saudi Arabia

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Riyadh, Saudi Arabia

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Bukit Merah, Singapore

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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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Daegu, South Korea

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Goyang-si, South Korea

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Incheon, 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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A Coruña, Spain

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Barcelona, Spain

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Barcelona, Spain

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Barcelona, Spain

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Córdoba, Spain

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El Palmar, Spain

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

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San Sebastián, Spain

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Seville, Spain

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Valencia, Spain

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Gothenburg, Sweden

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Örebro, Sweden

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Stockholm, Sweden

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Uppsala, Sweden

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Vaxjo, Sweden

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Taichung, Taiwan

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Tainan, 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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Cambridge, United Kingdom

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Cardiff, United Kingdom

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Edinburgh, United Kingdom

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Guildford, United Kingdom

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Leeds, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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Northwood, United Kingdom