An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)
NCT ID: NCT05952557
Last Updated: 2025-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
5500 participants
INTERVENTIONAL
2023-10-05
2037-05-06
Brief Summary
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Detailed Description
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Patients will be followed for 10 years from randomization of the last patient.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: standard endocrine therapy of investigator´s choice ± abemaciclib
standard endocrine therapy of investigator's choice (aromatase inhibitors \[AI; exemestane, letrozole, anastrozole\] or tamoxifen) ± abemaciclib
Tamoxifen
Tamoxifen. Comparator. Administered orally
Anastrozole
Anastrozole. Comparator. Administered orally
Letrozole
Letrozole. Comparator. Administered orally
Exemestane
Exemestane. Comparator. Administered orally
Abemaciclib
Abemaciclib adjuvant treatment Administered orally
Arm B: camizestrant ± abemaciclib
camizestrant ± abemaciclib
Camizestrant
Camizestrant. Experimental. Administered orally
Abemaciclib
Abemaciclib adjuvant treatment Administered orally
Interventions
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Camizestrant
Camizestrant. Experimental. Administered orally
Tamoxifen
Tamoxifen. Comparator. Administered orally
Anastrozole
Anastrozole. Comparator. Administered orally
Letrozole
Letrozole. Comparator. Administered orally
Exemestane
Exemestane. Comparator. Administered orally
Abemaciclib
Abemaciclib adjuvant treatment Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with absence of any evidence of metastatic disease as defined in the protocol.
* Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy.
* Patients must be randomised within 12 months of definitive breast surgery.
* Patients may have received up to 12 weeks of endocrine therapy prior to randomisation.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
* Adequate organ and bone marrow function
Exclusion Criteria
* Pathological complete response following treatment with neoadjuvant therapy
* History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered a very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation
* Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance "
* Known LVEF \<50% with heart failure NYHA Grade ≥2.
* Mean resting QTcF interval \> 480 ms at screening
* Concurrent exogenous reproductive hormone therapy or non topical hormonal therapy for non-cancer-related conditions
* Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors ( eg, denosumab)
* Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant
* Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding.
* Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-/peri-menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists that would preclude the patient from receiving any LHRH agonist.
18 Years
130 Years
ALL
No
Sponsors
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Austrian Breast and Colorectal Cancer Study Group (ABCSG)
UNKNOWN
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Dothan, Alabama, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Fayetteville, Arkansas, United States
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Duarte, California, United States
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Fountain Valley, California, United States
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Greenbrae, California, United States
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Irvine, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Monterey, California, United States
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Walnut Creek, California, United States
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West Hollywood, California, United States
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Aurora, Colorado, United States
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Littleton, Colorado, United States
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Littleton, Colorado, United States
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New Haven, Connecticut, United States
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Newark, Delaware, United States
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Washington D.C., District of Columbia, United States
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Clearwater, Florida, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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Plantation, Florida, United States
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St. Petersburg, Florida, United States
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Tallahassee, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Marietta, Georgia, United States
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Savannah, Georgia, United States
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Thomasville, Georgia, United States
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Chicago, Illinois, United States
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Elmhurst, Illinois, United States
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Naperville, Illinois, United States
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Park Ridge, Illinois, United States
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Plainfield, Illinois, United States
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Urbana, Illinois, United States
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Fort Wayne, Indiana, United States
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Des Moines, Iowa, United States
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Fairway, Kansas, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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Scarborough, Maine, United States
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Annapolis, Maryland, United States
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Detroit, Michigan, United States
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Charlottesville, Virginia, United States
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Norfolk, Virginia, United States
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Roanoke, Virginia, United States
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Puyallup, Washington, United States
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Spokane, Washington, United States
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Vancouver, Washington, United States
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Morgantown, West Virginia, United States
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Appleton, Wisconsin, United States
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Buenos Aires, , Argentina
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Natal, , Brazil
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Kelowna, British Columbia, Canada
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North Vancouver, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Barrie, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Kingston, Ontario, Canada
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Sault Ste. Marie, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Windsor, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Lévis, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Concepción, , Chile
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La Serena, , Chile
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Port Montt, , Chile
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Providencia, , Chile
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Temuco, , Chile
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Viña del Mar, , Chile
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Baoding, , China
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Dalian, , China
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Foshan, , China
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Hefei, , China
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Hefei, , China
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Hohhot, , China
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Huizhou, , China
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Jinzhou, , China
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Lanzhou, , China
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Linyi, , China
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Liuzhou, , China
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Liuzhou, , 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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Nantong, , China
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Neijiang, , China
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Shandong, , China
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Shangqiu, , China
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Shantou, , China
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Shaoguan Shi, , China
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Shenyang, , China
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Shenyang, , China
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Shenzhen, , China
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Shenzhen, , China
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Shijiazhuang, , China
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Suining Shi, , China
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Suzhou, , China
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Taizhou, , China
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Tianjin, , China
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Weifang, , China
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Wuhan, , China
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Xi'an, , China
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Xiangyang, , China
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Xinxiang, , China
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Xuzhou, , China
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Zunyi, , China
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Barranquilla, , Colombia
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Bogotá, , Colombia
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Cali, , Colombia
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Medellín, , Colombia
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Montería, , Colombia
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Valledupar, , Colombia
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Osijek, , Croatia
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Rijeka, , Croatia
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Split, , Croatia
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Zadar, , Croatia
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Zagreb, , Croatia
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Brno, , Czechia
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Hořovice, , Czechia
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Liberec, , Czechia
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Pardubice, , Czechia
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Prague, , Czechia
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Tallinn, , Estonia
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Angers, , France
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Bordeaux, , France
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Caen, , France
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Budapest, , Hungary
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Iruma-Gun, , Japan
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Isehara-shi, , Japan
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Kagoshima, , Japan
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Kashiwa, , Japan
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Kōtoku, , Japan
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Kumamoto, , Japan
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Kurume-shi, , Japan
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Kyoto, , Japan
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Matsuyama, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Niigata, , Japan
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Osaka, , Japan
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Ota-shi, , Japan
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Sapporo, , Japan
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Sapporo, , Japan
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Sendai, , Japan
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Shinagawa-ku, , Japan
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Suita-shi, , 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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Yokohama, , Japan
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Yokohama, , Japan
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Johor Bahru, , Malaysia
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Kota Bharu, , 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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Malacca, , Malaysia
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Pulau Pinang, , Malaysia
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Alc. Cuauhtémoc, , Mexico
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Alc. Cuauhtémoc, , Mexico
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Cancún, , Mexico
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Colonia Lindavista, , Mexico
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Estado de México, , Mexico
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Mérida, , Mexico
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Mérida, , Mexico
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México, , Mexico
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Monterrey, , Mexico
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Monterrey, , Mexico
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San Luis Potosí City, , Mexico
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Tuxtla Gutiérrez, , Mexico
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Veracruz, , Mexico
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Auckland, , New Zealand
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Hamilton, , New Zealand
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Palmerston North, , New Zealand
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Arequipa, , Peru
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La Libertad, , 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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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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San Isidro, , Peru
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Trujillo, , Peru
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Bacolod, , Philippines
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Cebu City, , Philippines
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Iloilo City, , Philippines
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Manila, , Philippines
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Quezon, , Philippines
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Bialystok, , Poland
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Biała Podlaska, , Poland
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Gdynia, , Poland
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Grudziądz, , Poland
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Koszalin, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Lublin, , Poland
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Opole, , Poland
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Poznan, , Poland
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Racibórz, , Poland
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Rzeszów, , Poland
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Rzeszów, , Poland
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Szczecin, , Poland
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Tomaszów Mazowiecki, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Amadora, , Portugal
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Braga, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Matosinhos Municipality, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Viana do Castelo, , Portugal
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Vila Nova de Gaia, , Portugal
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Vila Real, , Portugal
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Rio Piedras, , Puerto Rico
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Bucharest, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Cluj-Napoca, , Romania
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Craiova, , Romania
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Craiova, , Romania
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Craiova, , Romania
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Floreşti, , Romania
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Iași, , Romania
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Oradea, , Romania
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Otopeni, , Romania
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Ovidiu, , Romania
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Piteşti, , Romania
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Sibiu, , Romania
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Timișoara, , Romania
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Timișoara, , Romania
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Riyadh, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Riyadh/MENA, , Saudi Arabia
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Belgrade, , Serbia
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Belgrade, , Serbia
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Belgrade, , Serbia
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Kragujevac, , Serbia
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Niš, , Serbia
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Novi Sad, , Serbia
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Valjevo, , Serbia
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Zrenjanin, , Serbia
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Bloemfontein, , South Africa
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eManzimtoti, , South Africa
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George, , South Africa
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Johannesburg, , South Africa
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Johannesburg, , South Africa
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Pietermaritzburg, , South Africa
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Port Elizabeth, , South Africa
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Pretoria, , South Africa
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Cheonan-si, , South Korea
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Daegu, , South Korea
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Goyang-si, , 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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Seoul, , South Korea
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A Coruña, , Spain
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A Coruña, , Spain
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Albacete, , Spain
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Alicante, , Spain
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Badalona, , Spain
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Barakaldo, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Burgos, , Spain
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Castellon, , Spain
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Cáceres, , Spain
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Córdoba, , Spain
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Donostia / San Sebastian, , Spain
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El Palmar, , Spain
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Elche(Alicante), , Spain
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Fuenlabrada, , Spain
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Girona, , Spain
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Granada, , Spain
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Granada, , Spain
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Jerez de la Frontera, , Spain
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La Laguna (Tenerife), , Spain
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León, , 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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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Manresa, , Spain
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Málaga, , Spain
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Málaga, , Spain
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Murcia, , Spain
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Palma de Mallorca, , Spain
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Reus,Tarragona, , Spain
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Sabadell, , Spain
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Salamanca, , Spain
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Sant Joan Despí, , Spain
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Seville, , Spain
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Seville, , Spain
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Seville, , Spain
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Toledo, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Vigo, , Spain
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Zaragoza, , Spain
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Baden, , Switzerland
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Basel, , Switzerland
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Bellinzona, , Switzerland
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Chur, , Switzerland
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Frauenfeld, , Switzerland
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La Chaux-de-Fonds, , Switzerland
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Lausanne, , Switzerland
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Lucerne, , Switzerland
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Lucerne, , Switzerland
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Sankt Gallen, , Switzerland
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Winterthur, , Switzerland
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Zurich, , Switzerland
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Hsinchu, , Taiwan
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Kaohsiung City, , Taiwan
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New Taipei City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Yongkang 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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Hat Yai, , Thailand
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Khon Kaen, , Thailand
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Bursa, , Turkey (Türkiye)
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Çankaya, , Turkey (Türkiye)
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Çiğli, , Turkey (Türkiye)
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Edirne, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Karşıyaka, , Turkey (Türkiye)
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Malatya, , Turkey (Türkiye)
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Samsun, , Turkey (Türkiye)
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Abu Dhabi, , United Arab Emirates
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Al Ain City, , United Arab Emirates
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Dubai, , United Arab Emirates
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Dubai, , United Arab Emirates
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Aberdeen, , United Kingdom
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Bath, , United Kingdom
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Brighton, , United Kingdom
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Burton-on-Trent, , United Kingdom
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Cambridge, , United Kingdom
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Derby, , United Kingdom
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Guildford, , United Kingdom
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Ipswich, , United Kingdom
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Lancaster, , United Kingdom
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Leeds, , United Kingdom
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Leicester, , United Kingdom
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Liverpool, , 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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London, , United Kingdom
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Manchester, , United Kingdom
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Northampton, , United Kingdom
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Oxford, , United Kingdom
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Reading, , United Kingdom
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Shrewsbury, , United Kingdom
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Stockton, , United Kingdom
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Sutton, , United Kingdom
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Sutton in Ashfield, , United Kingdom
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Taunton, , United Kingdom
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Warwick, , United Kingdom
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Whitchurch, , United Kingdom
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Central Contacts
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References
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Hamilton EP, Loibl S, Bachelot T, Gnant M, Niikura N, Park YH, Tolaney SM, Pistilli B, Rastogi P, Saini KS, Gioni I, Johnston S, Nunes R, Quintana A, Stuart M, Syta E, Walding A, Klinowska T, Mayer IA. CAMBRIA-1 & CAMBRIA-2 phase III trials: camizestrant versus standard endocrine therapy in ER+/HER2- early breast cancer. Future Oncol. 2025 Mar;21(7):795-806. doi: 10.1080/14796694.2025.2459548. Epub 2025 Feb 27.
Related Links
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Breast Cancer Study Locator details (for US)
Other Identifiers
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2023-504031-41-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D8535C00001
Identifier Type: -
Identifier Source: org_study_id
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