A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
NCT ID: NCT05774951
Last Updated: 2025-12-22
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
4300 participants
INTERVENTIONAL
2023-03-31
2036-05-29
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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Keywords
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Study Design
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RANDOMIZED
PARALLEL
* Arm A: Continue standard ET of investigator's choice (aromatase inhibitors \[AI; exemestane, letrozole, anastrozole\] or tamoxifen)
* Arm B: Camizestrant
TREATMENT
NONE
Study Groups
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Arm A: standard endocrine therapy of investigator´s choice
Continue standard endocrine therapy of investigator's choice (aromatase inhibitors \[AI; exemestane, letrozole, anastrozole\] or tamoxifen)
Tamoxifen
Tamoxifen. Comparator. Administered per local approved label
Anastrozole
Anastrozole. Comparator. Administered per local approved label
Letrozole
Letrozole. Comparator. Administered per local approved label
Exemestane
Exemestane. Comparator. Administered per local approved label
Arm B: camizestrant
Camizestrant
Camizestrant
Camizestrant. Experimental. Administered orally
Interventions
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Camizestrant
Camizestrant. Experimental. Administered orally
Tamoxifen
Tamoxifen. Comparator. Administered per local approved label
Anastrozole
Anastrozole. Comparator. Administered per local approved label
Letrozole
Letrozole. Comparator. Administered per local approved label
Exemestane
Exemestane. Comparator. Administered per local approved label
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 high or intermediate risk of recurrence, based on clinical-pathological risk features, 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
* Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/- CDK4/6 inhibitor)
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
* Adequate organ and 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 at 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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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
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Dothan, Alabama, United States
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Anchorage, Alaska, United States
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Chandler, Arizona, United States
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Hot Springs, Arkansas, United States
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Anaheim, California, United States
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Beverly Hills, California, United States
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Concord, California, United States
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Corona, California, United States
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Fountain Valley, California, United States
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Greenbrae, California, United States
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Los Alamitos, California, United States
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Palo Alto, California, United States
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Palo Alto, California, United States
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San Diego, California, United States
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Whittier, California, United States
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Aurora, Colorado, United States
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Hartford, Connecticut, United States
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Fort Myers, Florida, United States
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Gainesville, Florida, United States
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Miami Beach, Florida, United States
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Orlando, Florida, United States
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Plantation, Florida, United States
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Port Saint Lucie, Florida, United States
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Saint Augustine, 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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Winter Haven, Florida, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Decatur, Illinois, United States
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Elmhurst, Illinois, United States
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Hinsdale, Illinois, United States
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Park Ridge, Illinois, United States
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Fort Wayne, Indiana, United States
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Iowa City, Iowa, United States
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Iowa City, Iowa, United States
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Fort Mitchell, Kentucky, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Brewer, Maine, United States
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Scarborough, Maine, United States
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Frederick, Maryland, United States
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Glenn Dale, Maryland, United States
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Silver Spring, Maryland, United States
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Independence, Missouri, United States
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Lincoln, Nebraska, United States
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Laconia, New Hampshire, United States
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Belleville, New Jersey, United States
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Farmington, New Mexico, United States
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Santa Fe, New Mexico, United States
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East Syracuse, New York, United States
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Stony Brook, New York, United States
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The Bronx, New York, United States
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White Plains, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Greensboro, North Carolina, United States
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Raleigh, North Carolina, United States
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Rocky Mount, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Reading, Pennsylvania, United States
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State College, Pennsylvania, United States
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Providence, Rhode Island, United States
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Mitchell, South Dakota, United States
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Sioux Falls, South Dakota, United States
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Yankton, South Dakota, United States
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Chattanooga, Tennessee, United States
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Lynchburg, Virginia, United States
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Midlothian, Virginia, United States
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Reston, Virginia, United States
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Richmond, Virginia, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Charleston, West Virginia, 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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CABA, , Argentina
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Capital Federal, , Argentina
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Viedma, , Argentina
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Concord, , Australia
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Linz, , Austria
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Dobrich, , Bulgaria
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Sofia, , Bulgaria
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Calgary, Alberta, Canada
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Kelowna, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Barrie, Ontario, Canada
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Ottawa, Ontario, Canada
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Sault Ste. Marie, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Saint-Jérôme, Quebec, Canada
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Concepción, , Chile
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La Serena, , Chile
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Santiago, , Chile
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Talca, , 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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Hefei, , China
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Hohhot, , China
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Huangpu District, , China
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Jinan, , China
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Lanzhou, , China
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Liuchow, , China
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Nanchang, , China
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Nanjing, , China
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Nanjing, , China
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Shantou, , China
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Shenyang, , China
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Suining, , China
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Suzhou, , China
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Taiyuan, , 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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Wuhan, , China
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Wuhan, , China
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Xiangyang, , China
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Xining, , China
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Xinxiang, , China
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Xuzhou, , China
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Xuzhou, , China
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Yanji, , China
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Yantai, , China
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Zhengzhou, , China
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Barranquilla, , Colombia
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Barranquilla, , Colombia
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Bogotá, , Colombia
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Cali, , Colombia
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Floridablanca, , Colombia
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Medellín, , Colombia
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Montería, , Colombia
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Pereira, , Colombia
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Valledupar, , Colombia
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Hořovice, , Czechia
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Pardubice, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Pragues, , Czechia
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Příbram, , Czechia
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Angers, , France
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Argenteuil, , France
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Avignon, , France
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Bordeaux, , France
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Bordeaux, , France
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Caen, , France
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Cholet, , France
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Clermont-Ferrand, , France
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Dijon, , France
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Epagny Metz-Tessy, , France
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Plerin SUR MER, , France
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Poitiers, , France
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Rennes, , France
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Suresnes, , France
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Velbert, , Germany
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Wiesbaden, , Germany
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Wuppertal, , Germany
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Athens, , Greece
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Kyoto, , Japan
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Yokohama, , Japan
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George Town, , Malaysia
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Mexico City, , Mexico
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Dirksland, , Netherlands
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Arequipa, , Peru
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Arequipa, , Peru
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Arequipa, , Peru
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Callao, , 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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Trujillo, , Peru
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Bacolod, , Philippines
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Cebu, , Philippines
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Iloilo City, , Philippines
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Manila, , Philippines
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Quezon City, , Philippines
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Quezon City, , Philippines
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Quezon City, , Philippines
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Bialystok, , Poland
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Grudziądz, , Poland
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Koszalin, , Poland
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Lodz, , 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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Warsaw, , Poland
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Wieliszew, , Poland
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Amadora, , Portugal
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Braga, , Portugal
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Guimarães, , 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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Porto, , Portugal
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Vila Nova de Gaia, , Portugal
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Baia Mare, , Romania
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Brasov, , Romania
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Cluj-Napoca, , Romania
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Cluj-Napoca, , Romania
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Constanța, , 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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Piteşti, , Romania
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Sibiu, , Romania
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Timișoara, , Romania
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Timișoara, , Romania
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Belgrade, , Serbia
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Belgrade, , Serbia
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Belgrade, , Serbia
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Kamenitz, , Serbia
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Kragujevac, , Serbia
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Niš, , Serbia
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Valjevo, , Serbia
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Zrenjanin, , Serbia
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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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Bloemfontein, , South Africa
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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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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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Pretoria, , South Africa
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Pretoria, , South Africa
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Soweto, , South Africa
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Busan, , South Korea
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Daegu, , South Korea
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Donggu, , South Korea
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Goyang-si, , South Korea
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Jeonnam, , South Korea
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Seongbuk-Gu, , 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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Alcoy, , Spain
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Alicante, , Spain
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Alzira, , Spain
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Badajoz, , Spain
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Badalona, , 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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Cáceres, , Spain
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Elche(Alicante), , Spain
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Galdakao, , 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 (Cádiz), , Spain
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L'Hospitalet de Llobregat, , Spain
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Leganés, , 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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Majadahonda, , Spain
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Manresa, , Spain
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Murcia, , Spain
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Oviedo, , Spain
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Parla, , Spain
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Port de Sagunt, , Spain
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Reus, , Spain
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Salamanca, , Spain
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San Sebastián, , Spain
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Sant Joan d'Alacant, , Spain
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Santander, , Spain
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Seville, , Spain
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Seville, , Spain
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Teruel, , 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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Hsinchu, , Taiwan
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Kaohsiung City, , Taiwan
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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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Bangkok, , Thailand
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Bangkok, , Thailand
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Khon Kaen, , Thailand
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Phisanulok, , Thailand
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Phitsanulok, , Thailand
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Rachathewi, , Thailand
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Songkhla, , 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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Ankara, , Turkey (Türkiye)
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Aydin, , Turkey (Türkiye)
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Bursa, , Turkey (Türkiye)
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Dinar, , 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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Izmir, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Samsun, , Turkey (Türkiye)
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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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Edinburgh, , United Kingdom
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Guildford, , United Kingdom
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Ipswich, , United Kingdom
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Keighley, , 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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Oxford, , United Kingdom
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Peterborough, , United Kingdom
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Stoke-on-Trent, , United Kingdom
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Sutton, , 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
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Huế, , Vietnam
Countries
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Central Contacts
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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
AstraZeneca Breast Cancer Study Locator Service
Role: CONTACT
Phone: 1-877-400-4655
Email: [email protected]
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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Description: Breast Cancer Study Locator details (for US)
Other Identifiers
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2022-501024-20-00
Identifier Type: OTHER
Identifier Source: secondary_id
D8531C00002
Identifier Type: -
Identifier Source: org_study_id