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ACTIVE NOT RECRUITING
NCT03997123
PHASE3

Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

Phase III Study of Capivasertib + Paclitaxel versus Placebo + Paclitaxel as First line Treatment for Patients with Locally Advanced or Metastatic Triple-negative Breast Cancer (TNBC)

Official title: A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib/+Paclitaxel vs Placebo+Paclitaxel as First-line Treatment for Patients With Locally Advanced (Inoperable) or Metastatic TNBC.

Key Details

Gender

All

Age Range

18 Years - 130 Years

Study Type

INTERVENTIONAL

Enrollment

923

Start Date

2019-06-25

Completion Date

2026-03-16

Last Updated

2025-12-22

Healthy Volunteers

No

Interventions

DRUG

Capivasertib

400 mg (2 oral tablets) given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle. Study treatment will be continued until disease progression unless there is evidence of unacceptable toxicity, or if the patient requests to stop the study treatment.

DRUG

Paclitaxel

80 mg/m2 concentrate for solution for infusion, 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle. Paclitaxel treatment will be continued for at least 6 cycles unless the patient experiences unacceptable toxicity that is attributed directly to treatment with paclitaxel.

DRUG

Placebo

Placebo: Oral tablets. 400 mg of Placebo (2 tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week offtreatment within each 28-day treatment cycle

Locations (260)

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Whittier, California, United States

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Whittier, California, United States

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Fort Myers, Florida, United States

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Miami, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Chicago, Illinois, United States

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Westwood, Kansas, United States

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Silver Spring, Maryland, United States

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Detroit, Michigan, United States

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Nyack, New York, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Harrisburg, Pennsylvania, United States

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Philadelphia, Pennsylvania, 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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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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Fairfax, Virginia, 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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Ciudad Autonomade Buenos Aires, 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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Barretos, Brazil

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Florianópolis, Brazil

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Goiânia, Brazil

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Londrina, 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 José do Rio Preto, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Victoria, British Columbia, Canada

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Kitchener, Ontario, Canada

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North York, Ontario, Canada

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Toronto, Ontario, Canada

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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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Chengdu, China

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Chengdu, China

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Foshan, China

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Guangzhou, China

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Guiyang, China

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Haikou, 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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Nanjing, China

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Nanyang, 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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Wenzhou, China

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Wuhan, China

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Wuhan, China

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Xi'an, China

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Zhengzhou, China

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Floridablanca, Colombia

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Ibagué, Colombia

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Medellín, Colombia

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Montería, Colombia

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Valledupar, Colombia

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Hradec Králové, Czechia

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Olomouc, Czechia

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Prague, Czechia

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Prague, Czechia

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Brest, France

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Lyon, 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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Saint-Herblain, France

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Villejuif, France

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Athens, Greece

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Athens, Greece

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Athens, Greece

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Heraklion, Greece

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Thessaloniki, Greece

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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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Nyíregyháza, Hungary

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Szekszárd, Hungary

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Bangalore, India

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Bangalore, India

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Gūrgaon, India

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Kolkata, India

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Kolkata, India

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Mumbai, India

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Mysuru, India

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Nagpur, India

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Nagpur, India

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Nashik, India

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New Delhi, India

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New Delhi, India

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Bunkyō City, Japan

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Fukuoka, Japan

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Hidaka-shi, Japan

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Hiroshima, Japan

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Kagoshima, Japan

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Kitaadachi-gun, Japan

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Kōtoku, Japan

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Kumamoto, Japan

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Matsuyama, Japan

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Nagoya, Japan

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Niigata, Japan

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Osaka, 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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Shinagawa-ku, Japan

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Shinjuku-ku, Japan

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Sunto-gun, Japan

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Takasaki-shi, Japan

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Tsu, Japan

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Tsukuba, Japan

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Yokohama, Japan

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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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Kuching, Malaysia

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Aguascalientes, Mexico

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Estado de México, Mexico

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Guadalajara, Mexico

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México, Mexico

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Monterrey, Mexico

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Tuxtla Gutiérrez, Mexico

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Tuxtla Gutiérrez, Mexico

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Arequipa, Peru

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Callao, Peru

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Lima, Peru

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Lima, Peru

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Lima, Peru

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Lima, Peru

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Bacolod, Philippines

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Baguio City, Philippines

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Cagayan de Oro, Philippines

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Cebu City, Philippines

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Davao City, Philippines

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Iloilo City, Philippines

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Iloilo City, Philippines

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Las Piñas, Philippines

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Legaspi, Philippines

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Manila, Philippines

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Quezon City, Philippines

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San Juan City, Philippines

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Bydgoszcz, Poland

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Konin, Poland

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Poznan, Poland

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Racibórz, Poland

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Radom, Poland

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Tomaszów Mazowiecki, 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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Porto, Portugal

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Arkhangelsk, 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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Volgograd, 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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Mecca, 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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Riyadh, Saudi Arabia

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Bratislava, Slovakia

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Johannesburg, South Africa

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Johannesburg, South Africa

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Pretoria, South Africa

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Pretoria, South Africa

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Busan, South Korea

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Cheonan-si, South Korea

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Cheongju-si, South Korea

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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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Seoul, South Korea

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Badalona, Spain

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Barcelona, Spain

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Barcelona, Spain

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Hospitalet deLlobregat, Spain

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Jaén, Spain

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Madrid, Spain

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Málaga, Spain

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Seville, Spain

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Valencia, Spain

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Zaragoza, Spain

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Gothenburg, Sweden

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Lund, Sweden

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Stockholm, Sweden

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Hsinchu, Taiwan

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Hualien City, Taiwan

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Kaohsiung City, Taiwan

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Kaohsiung City, 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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Bangkok, Thailand

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Bangkok, Thailand

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Bangkok, Thailand

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Bangkok, Thailand

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Hat Yai, Thailand

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Mueang, Thailand

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Ankara, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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Malatya, Turkey (Türkiye)

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Mersin, Turkey (Türkiye)

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Edinburgh, United Kingdom

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London, United Kingdom

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London, United Kingdom

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London, United Kingdom

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Sheffield, United Kingdom

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Surrey, United Kingdom

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York, United Kingdom

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Hanoi, Vietnam

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Ho Chi Minh City, Vietnam

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Ho Chi Minh City, Vietnam