Breast Cancer, Early Breast CancerPhase 3CAMBRIA-1NCT05774951
A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
A Phase 3 study testing Camizestrant, Tamoxifen and Anastrozole in people with Breast Cancer, Early Breast Cancer, run by AstraZeneca at 709 sites in 39 countries.
Trial summary
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard… Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Breast Cancer, Early Breast Cancer
- What is being tested?
- Camizestrant, Tamoxifen and Anastrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,300 participants
- Where
- 709 sitesin 39 countries
- Study dates
- 31 Mar 2023to 29 May 2036
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women and Men, ≥18 years at the time of screening (or per national guidelines)
- 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
Who cannot join
- Inoperable locally advanced or metastatic breast cancer
- 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
Show all 11Show fewer
- Concurrent exogenous sex hormone therapy
- 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
Trial locations and contacts
709 sites in 39 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
709 sites in 39 countries
United States127 sites, 4 recruiting
- Recruiting
Research Site
Aberdeen, South Dakota, 57401
- Active, not recruiting
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Anaheim, California, 92801
- Active, not recruiting
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Anchorage, Alaska, 99508
- Active, not recruiting
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Ann Arbor, Michigan, 48109
- Withdrawn
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Appleton, Wisconsin, 54911
- Active, not recruiting
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Atlanta, Georgia, 30310
- Active, not recruiting
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Atlanta, Georgia, 30318
- Withdrawn
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Aurora, Colorado, 80045
- Withdrawn
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Austin, Texas, 78731
- Active, not recruiting
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Baton Rouge, Louisiana, 70809
- Active, not recruiting
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Belleville, New Jersey, 07109
- Active, not recruiting
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Beverly Hills, California, 90211
- Active, not recruiting
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Birmingham, Alabama, 35205
- Withdrawn
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Boston, Massachusetts, 02111
- Withdrawn
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Brewer, Maine, 04412
- Active, not recruiting
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Chandler, Arizona, 85224
- Withdrawn
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Charleston, West Virginia, 25304
- Active, not recruiting
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Charlotte, North Carolina, 28204
- Active, not recruiting
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Chattanooga, Tennessee, 37404
- Withdrawn
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Chicago, Illinois, 60608
- Active, not recruiting
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Chicago, Illinois, 60637
- Withdrawn
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Cincinnati, Ohio, 45219
- Active, not recruiting
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Cincinnati, Ohio, 45255
- Active, not recruiting
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Clairton, Pennsylvania, 15025
- Active, not recruiting
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Cleveland, Ohio, 44106
- Active, not recruiting
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Cleveland, Ohio, 44195
- Active, not recruiting
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Columbus, Georgia, 31904
- Active, not recruiting
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Concord, California, 94520
- Active, not recruiting
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Corona, California, 92882
- Active, not recruiting
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Dallas, Texas, 75230
- Active, not recruiting
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Decatur, Illinois, 62526
- Active, not recruiting
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Denton, Texas, 76201
- Active, not recruiting
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Detroit, Michigan, 48202
- Active, not recruiting
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Dothan, Alabama, 36303
- Active, not recruiting
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Durham, North Carolina, 27710-0001
- Active, not recruiting
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East Lansing, Michigan, 48824
- Active, not recruiting
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East Syracuse, New York, 13057
- Active, not recruiting
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Elmhurst, Illinois, 60126
- Active, not recruiting
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Fairfax, Virginia, 22031
- Active, not recruiting
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Farmington, New Mexico, 87401
- Active, not recruiting
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Fort Mitchell, Kentucky, 41017
- Active, not recruiting
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Fort Myers, Florida, 33901
- Active, not recruiting
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Fort Wayne, Indiana, 46804
- Active, not recruiting
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Fountain Valley, California, 92708
- Active, not recruiting
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Frederick, Maryland, 21702
- Active, not recruiting
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Gainesville, Florida, 32603
- Active, not recruiting
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Glenn Dale, Maryland, 20769
- Active, not recruiting
Research Site
Greenbrae, California, 94904
- Withdrawn
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Greensboro, North Carolina, 27403
- Active, not recruiting
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Hartford, Connecticut, 06102
- Active, not recruiting
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Hinsdale, Illinois, 60521
- Withdrawn
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Honolulu, Hawaii, 96813
- Active, not recruiting
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Hot Springs, Arkansas, 71913
- Active, not recruiting
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Houston, Texas, 77024
- Active, not recruiting
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Houston, Texas, 77030
- Active, not recruiting
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Hyannis, Massachusetts, 02601
- Active, not recruiting
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Independence, Missouri, 64057
- Active, not recruiting
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Iowa City, Iowa, 52242
- Recruiting
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Irving, Texas, 75063
- Active, not recruiting
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Knoxville, Tennessee, 37920
- Active, not recruiting
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Laconia, New Hampshire, 03246
- Withdrawn
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Lancaster, South Carolina, 29720
- Active, not recruiting
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Lansing, Michigan, 48910
- Terminated
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Las Vegas, Nevada, 89148
- Active, not recruiting
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Lexington, Kentucky, 40536
- Active, not recruiting
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Lincoln, Nebraska, 68506
- Active, not recruiting
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Los Alamitos, California, 90720
- Active, not recruiting
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Louisville, Kentucky, 40202
- Active, not recruiting
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Lynchburg, Virginia, 24501
- Active, not recruiting
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Madison, Wisconsin, 53792
- Active, not recruiting
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Miami Beach, Florida, 33140
- Active, not recruiting
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Midlothian, Virginia, 23114
- Active, not recruiting
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Milwaukee, Wisconsin, 53226
- Active, not recruiting
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Mitchell, South Dakota, 57301
- Active, not recruiting
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Morgantown, West Virginia, 26505
- Active, not recruiting
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Nashville, Tennessee, 37203
- Active, not recruiting
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Nashville, Tennessee, 37204
- Withdrawn
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New Hyde Park, New York, 11042
- Active, not recruiting
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New York, New York, 10011
- Withdrawn
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New York, New York, 10019
- Active, not recruiting
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New York, New York, 10029
- Active, not recruiting
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Ogden, Utah, 84405
- Active, not recruiting
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Orlando, Florida, 32806
- Active, not recruiting
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Palo Alto, California, 94304
- Terminated
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Park Ridge, Illinois, 60068
- Active, not recruiting
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Park Ridge, Illinois, 60068
- Active, not recruiting
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Philadelphia, Pennsylvania, 19106
- Active, not recruiting
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Philadelphia, Pennsylvania, 19111
- Recruiting
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Pierre, South Dakota, 57501
- Active, not recruiting
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Pittsburgh, Pennsylvania, 15213
- Active, not recruiting
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Plantation, Florida, 33324
- Active, not recruiting
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Port Saint Lucie, Florida, 34952
- Active, not recruiting
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Providence, Rhode Island, 02903
- Active, not recruiting
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Raleigh, North Carolina, 27607
- Active, not recruiting
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Reading, Pennsylvania, 19611
- Active, not recruiting
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Reston, Virginia, 20190
- Active, not recruiting
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Richmond, Virginia, 23235
- Active, not recruiting
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Rocky Mount, North Carolina, 27804
- Active, not recruiting
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Royal Oak, Michigan, 48073
- Active, not recruiting
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Saint Augustine, Florida, 32086
- Active, not recruiting
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Salt Lake City, Utah, 84106
- Active, not recruiting
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San Diego, California, 92121
- Active, not recruiting
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San Diego, California, 92123
- Active, not recruiting
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Santa Fe, New Mexico, 87505
- Withdrawn
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Scarborough, Maine, 04074
- Active, not recruiting
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Seattle, Washington, 98101
- Active, not recruiting
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Seattle, Washington, 98104
- Active, not recruiting
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Silver Spring, Maryland, 20910
- Active, not recruiting
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Sioux Falls, South Dakota, 57105
- Active, not recruiting
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Spartanburg, South Carolina, 29303
- Active, not recruiting
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Spokane, Washington, 99202
- Active, not recruiting
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St. Petersburg, Florida, 33705
- Active, not recruiting
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St. Petersburg, Florida, 33709
- Terminated
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State College, Pennsylvania, 16803
- Active, not recruiting
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Stony Brook, New York, 11794
- Active, not recruiting
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Tacoma, Washington, 98405
- Active, not recruiting
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Tallahassee, Florida, 32308
- Active, not recruiting
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The Bronx, New York, 10461
- Active, not recruiting
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Towson, Maryland, 21204
- Active, not recruiting
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West Palm Beach, Florida, 33401
- Active, not recruiting
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White Plains, New York, 10601
- Active, not recruiting
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Whittier, California, 90603
- Recruiting
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Winston-Salem, North Carolina, 27103
- Active, not recruiting
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Winston-Salem, North Carolina, 27104
- Active, not recruiting
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Winter Haven, Florida, 33880
- Active, not recruiting
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Yankton, South Dakota, 57078
- Withdrawn
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Youngstown, Ohio, 44504
China66 sites
- Active, not recruiting
Research Site
Baoding, 071000
- Active, not recruiting
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Beijing, 100005
- Withdrawn
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Beijing, 100021
- Active, not recruiting
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Beijing, 100044
- Active, not recruiting
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Beijing, 100142
- Withdrawn
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Beijing
- Active, not recruiting
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Changchun, 130021
- Active, not recruiting
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Changsha, 410008
- Active, not recruiting
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Chengdu, 610000
- Active, not recruiting
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Chengdu, 610041
- Active, not recruiting
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Chengdu, 610072
- Active, not recruiting
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Chifeng, 024000
- Active, not recruiting
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Dalian, 116023
- Active, not recruiting
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Foshan, 528000
- Withdrawn
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Fuzhou, 350001
- Active, not recruiting
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Fuzhou, 350011
- Active, not recruiting
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Guangzhou, 510060
- Withdrawn
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Guangzhou, 510120
- Withdrawn
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Guangzhou, 510168
- Withdrawn
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Haikou, 570102
- Active, not recruiting
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Haikou, 570311
- Active, not recruiting
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Hangzhou, 310003
- Active, not recruiting
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Hangzhou, 310009
- Active, not recruiting
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Hangzhou, 310020
- Active, not recruiting
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Hangzhou, 310022
- Active, not recruiting
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Harbin, 150081
- Active, not recruiting
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Hefei, 230001
- Active, not recruiting
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Hefei, 230012
- Active, not recruiting
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Hefei, 230601
- Active, not recruiting
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Hohhot, 010010
- Withdrawn
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Huangpu District, 200025
- Active, not recruiting
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Jinan, 2501117
- Active, not recruiting
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Lanzhou, 730050
- Active, not recruiting
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Liuzhou, 545005
- Active, not recruiting
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Nanchang, 330009
- Active, not recruiting
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Nanjing, 210009
- Active, not recruiting
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Nanjing, 210029
- Withdrawn
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Nanning, 530021
- Active, not recruiting
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Nanning, 530021
- Active, not recruiting
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Neijiang, 641000
- Withdrawn
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Qingdao, 266100
- Withdrawn
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Shanghai, 200032
- Active, not recruiting
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Shanghai, 200032
- Active, not recruiting
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Shanghai, 200127
- Withdrawn
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Shantou, 515031
- Active, not recruiting
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Shaoguan, 512027
- Withdrawn
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Shenyang, 110001
- Active, not recruiting
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Shenyang, 110016
- Active, not recruiting
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Shijiazhuang, 050020
- Active, not recruiting
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Suining, 629000
- Active, not recruiting
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Suzhou, 215006
- Withdrawn
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Taiyuan, 030000
- Active, not recruiting
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Taizhou, 317000
- Active, not recruiting
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Tianjin, 300060
- Active, not recruiting
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Weifang, 261000
- Active, not recruiting
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Wuhan, 430022
- Active, not recruiting
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Wuhan, 430070
- Active, not recruiting
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Wuhan, 430079
- Active, not recruiting
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Xiangfan, 441021
- Withdrawn
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Xining, 810001
- Active, not recruiting
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Xinxiang, 453100
- Active, not recruiting
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Xuzhou, 221000
- Active, not recruiting
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Xuzhou, 221009
- Active, not recruiting
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Yanji, 133000
- Active, not recruiting
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Yantai, 264000
- Active, not recruiting
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Zhengzhou, 450052
Spain44 sites
- Active, not recruiting
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A Coruña, 15006
- Active, not recruiting
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A Coruña, 15009
- Active, not recruiting
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Albacete, 02006
- Active, not recruiting
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Alcoy, 3804
- Active, not recruiting
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Alicante, 3015
- Active, not recruiting
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Alzira, 46600
- Active, not recruiting
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Badajoz, 06080
- Active, not recruiting
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Badalona, 08003
- Active, not recruiting
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Badalona, 08916
- Active, not recruiting
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Barakaldo, 48903
- Active, not recruiting
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Barcelona, 08028
- Active, not recruiting
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Barcelona, 08036
- Active, not recruiting
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Barcelona, 8035
- Active, not recruiting
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Cáceres, 10003
- Active, not recruiting
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Elche(Alicante), 03202
- Active, not recruiting
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Galdakao, 48960
- Active, not recruiting
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Girona, 17007
- Active, not recruiting
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Granada, 18007
- Active, not recruiting
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Granada, 18014
- Active, not recruiting
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Jerez de La Frontera (Cádiz), 11407
- Active, not recruiting
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L'Hospitalet de Llobregat, 08908
- Active, not recruiting
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Leganés, 28911
- Active, not recruiting
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Lleida, 25198
- Active, not recruiting
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Madrid, 28033
- Active, not recruiting
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Madrid, 28040
- Active, not recruiting
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Madrid, 28050
- Active, not recruiting
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Majadahonda, 28222
- Active, not recruiting
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Manresa, 8242
- Active, not recruiting
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Murcia, 30008
- Active, not recruiting
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Oviedo, 33011
- Active, not recruiting
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Parla, 28981
- Active, not recruiting
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Port de Sagunt, 46520
- Active, not recruiting
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Reus, 43204
- Active, not recruiting
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Salamanca, 37007
- Active, not recruiting
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San Sebastián, 20014
- Withdrawn
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Sant Joan d'Alacant, 03550
- Active, not recruiting
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Santander, 39008
- Active, not recruiting
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Seville, 41009
- Active, not recruiting
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Seville, 41013
- Terminated
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Teruel, 44001
- Withdrawn
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Toledo, 45007
- Active, not recruiting
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Valencia, 46009
- Active, not recruiting
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Valencia, 46015
- Active, not recruiting
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Valencia, 46017
Brazil37 sites, 4 recruiting
- Active, not recruiting
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Alfenas, 37130-000
- Active, not recruiting
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Belo Horizonte, 30130-100
- Active, not recruiting
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Belo Horizonte, 30150-274
- Withdrawn
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Brasília, 70390-700
- Active, not recruiting
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Brasília, 71681-603
- Active, not recruiting
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Chapecó, 89812-220
- Terminated
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Cuiabá, 78040-400
- Active, not recruiting
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Curitiba, 80810-050
- Recruiting
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Curitiba, 81520-060
- Active, not recruiting
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Fortaleza, 60170-170
- Active, not recruiting
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Fortaleza, 60430-230
- Active, not recruiting
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Lajeado, 95900000
- Recruiting
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Londrina, 86015-520
- Active, not recruiting
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Natal, 59075-740
- Active, not recruiting
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Niterói, 24020-096
- Active, not recruiting
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Piracicaba, 13419-155
- Active, not recruiting
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Porto Alegre, 90035-001
- Active, not recruiting
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Porto Alegre, 90035-903
- Active, not recruiting
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Porto Alegre, 90050-170
- Active, not recruiting
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Porto Alegre, 90880-480
- Active, not recruiting
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Pouso Alegre, 37554-216
- Active, not recruiting
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Recife, 50070-070
- Active, not recruiting
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Ribeirão Preto, 14051-140
- Active, not recruiting
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Rio de Janeiro, 20560-120
- Active, not recruiting
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Rio de Janeiro, 22250-905
- Recruiting
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Rio de Janeiro, 22290-160
- Withdrawn
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Salvador, 40110-060
- Active, not recruiting
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Salvador, 41253-190
- Active, not recruiting
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São Paulo, 01236-030
- Active, not recruiting
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São Paulo, 01317-001
- Active, not recruiting
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São Paulo, 01323-001
- Active, not recruiting
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São Paulo, 01508-010
- Active, not recruiting
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São Paulo, 01509-900
- Active, not recruiting
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São Paulo, 08270-070
- Recruiting
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Taubaté, 12030-200
- Active, not recruiting
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Três Lagoas, 79601-001
- Active, not recruiting
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Vitória, 29055-450
Germany35 sites, 27 recruiting
- Recruiting
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Aachen, 52074
- Recruiting
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Augsburg, 86150
- Withdrawn
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Bayreuth, 95445
- Recruiting
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Berlin, 10317
- Recruiting
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Berlin, 12623
- Recruiting
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Bonn, 53111
- Withdrawn
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Deggendorf, 94469
- Recruiting
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Dessau, 6847
- Recruiting
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Dresden, 01307
- Recruiting
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Düsseldorf, 40225
- Recruiting
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Düsseldorf, 40235
- Recruiting
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Eggenfelden, 84307
- Recruiting
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Esslingen am Neckar, 73730
- Recruiting
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Georgsmarienhütte, 49124
- Recruiting
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Gütersloh, 33332
- Recruiting
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Hamburg, 20259
- Recruiting
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Hamburg, 21073
- Recruiting
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Heidelberg, 69120
- Withdrawn
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Kiel, 24105
- Recruiting
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Landshut, 84036
- Withdrawn
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Lübeck, 23562
- Withdrawn
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Mainz, 55131
- Recruiting
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Memmingen, 87700
- Recruiting
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München, 80637
- Recruiting
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Ravensburg, 88212
- Recruiting
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Rüsselsheim am Main, 65428
- Recruiting
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Stralsund, 18439
- Recruiting
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Torgau, 4860
- Recruiting
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Trier, 54290
- Withdrawn
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Ulm, 89075
- Withdrawn
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Velbert, 42551
- Withdrawn
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Wiesbaden, 65189
- Recruiting
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Wiesbaden, 65199
- Recruiting
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Worms, 67550
- Recruiting
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Wuppertal, 42283
France34 sites
- Withdrawn
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Angers, 49055
- Active, not recruiting
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Argenteuil, 95100
- Active, not recruiting
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Avignon, 84918
- Active, not recruiting
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Bordeaux, 33000
- Active, not recruiting
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Bordeaux, 33077
- Withdrawn
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Bourg-en-Bresse, 01012
- Active, not recruiting
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Caen, 14076
- Active, not recruiting
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Cholet, 49300
- Withdrawn
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Clermont-Ferrand, 63011
- Withdrawn
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Dijon, 21079
- Withdrawn
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Epagny Metz-Tessy, 74370
- Active, not recruiting
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Lille, 59000
- Active, not recruiting
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Lorient, 56322
- Active, not recruiting
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Lyon, 69008
- Active, not recruiting
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Marseille, 13273
- Active, not recruiting
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Metz, 57085
- Active, not recruiting
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Montpellier, 34070
- Active, not recruiting
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Montpellier, 34298
- Active, not recruiting
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Nantes, 44202
- Active, not recruiting
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Nîmes, 30029
- Withdrawn
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Paris, 75010
- Active, not recruiting
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Paris, 75013
- Active, not recruiting
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Pierre-Bénite, 69310
- Active, not recruiting
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Plerin SUR MER, 22190
- Active, not recruiting
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Poitiers, 86021
- Active, not recruiting
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Quimper, 29107
- Withdrawn
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Rennes, 35042
- Withdrawn
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Saint-Cloud, 92210
- Withdrawn
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Saint-Herblain, 44805
- Active, not recruiting
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Saint-Priest-en-Jarez, 42270
- Active, not recruiting
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Suresnes, 92151
- Active, not recruiting
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Toulouse, 31059
- Active, not recruiting
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Tours, 37044
- Active, not recruiting
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Villejuif, 94805
Japan34 sites
- Active, not recruiting
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Chiba, 260-8717
- Active, not recruiting
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Chūōku, 104-8560
- Active, not recruiting
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Fukuoka, 811-1395
- Active, not recruiting
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Fukushima, 960-1295
- Active, not recruiting
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Hidaka-shi, 350-1298
- Active, not recruiting
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Hirakata-shi, 573-1191
- Active, not recruiting
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Hiroshima, 730-0011
- Active, not recruiting
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Isehara-shi, 259-1193
- Active, not recruiting
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Kagoshima, 892-0833
- Active, not recruiting
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Kashiwa, 227-8577
- Active, not recruiting
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Kitaadachi-gun, 362-0806
- Active, not recruiting
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Kōtoku, 135-8550
- Active, not recruiting
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Kumamoto, 860-8556
- Active, not recruiting
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Kurume-shi, 830-0013
- Active, not recruiting
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Kyoto, 606-8507
- Active, not recruiting
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Matsuyama, 791-0280
- Active, not recruiting
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Nagoya, 464-8681
- Active, not recruiting
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Nagoya, 466-8560
- Active, not recruiting
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Nagoya, 467-0001
- Active, not recruiting
Research Site
Niigata, 951-8566
- Active, not recruiting
Research Site
Ōita, 870-8511
- Active, not recruiting
Research Site
Osaka, 533-0024
- Active, not recruiting
Research Site
Osaka, 540-0006
- Active, not recruiting
Research Site
Osaka, 541-8567
- Active, not recruiting
Research Site
Ota-shi, 373-8550
- Active, not recruiting
Research Site
Sagamihara-shi, 252-0375
- Active, not recruiting
Research Site
Sapporo, 060-8648
- Active, not recruiting
Research Site
Sendai, 980-8574
- Active, not recruiting
Research Site
Shinagawa-ku, 142-8666
- Active, not recruiting
Research Site
Suita-shi, 565-0871
- Active, not recruiting
Research Site
Sunto-gun, 411-8777
- Active, not recruiting
Research Site
Takasaki-shi, 370-0829
- Active, not recruiting
Research Site
Tsu, 514-8507
- Active, not recruiting
Research Site
Yokohama, 241-8515
India18 sites
- Terminated
Research Site
Bangalore, 560027
- Withdrawn
Research Site
Bangalore, 560076
- Withdrawn
Research Site
Belagavi, 590010
- Withdrawn
Research Site
Bhubaneswar, 751019
- Active, not recruiting
Research Site
Hubli, 580029
- Withdrawn
Research Site
Hyderabad, 500082
- Withdrawn
Research Site
Jaipur, 302017
- Active, not recruiting
Research Site
Kolkata, 700020
- Active, not recruiting
Research Site
Mumbai, 400 012
- Withdrawn
Research Site
Nagpur, 440026
- Active, not recruiting
Research Site
Nashik, 422005
- Active, not recruiting
Research Site
New Delhi, 110 085
- Withdrawn
Research Site
New Delhi, 110005
- Withdrawn
Research Site
New Delhi, 110076
- Withdrawn
Research Site
Pune, 411004
- Withdrawn
Research Site
Thane, 401107
- Active, not recruiting
Research Site
Visakhapatnam, 530040
- Terminated
Research Site
West Bengal, 700 156
Argentina16 sites
- Withdrawn
Research Site
Buenos Aires, C1430EGF
- Active, not recruiting
Research Site
CABA, C1119ACN
- Active, not recruiting
Research Site
Capital Federal, C1417DTB
- Active, not recruiting
Research Site
Ciudad Autónoma Buenos Aires, 1125
- Active, not recruiting
Research Site
Ciudad de Buenos Aires, 1280
- Active, not recruiting
Research Site
Ciudad de Buenos Aires, C1118AAT
- Active, not recruiting
Research Site
Ciudad de Buenos Aires, C1426ANZ
- Active, not recruiting
Research Site
Córdoba, 5000
- Active, not recruiting
Research Site
Córdoba, 5001
- Active, not recruiting
Research Site
La Plata, 1900
- Active, not recruiting
Research Site
Mar del Plata, 7600
- Withdrawn
Research Site
Salta, A4400EMI
- Active, not recruiting
Research Site
San Juan, 5400
- Active, not recruiting
Research Site
San Miguel de Tucumán, 4000
- Active, not recruiting
Research Site
San Miguel de Tucumán, T4000IAK
- Active, not recruiting
Research Site
Viedma, R8500ACE
Italy16 sites
- Active, not recruiting
Research Site
Bari, 70124
- Active, not recruiting
Research Site
Catania, 95126
- Active, not recruiting
Research Site
Catanzaro, 88100
- Active, not recruiting
Research Site
Florence, 50134
- Active, not recruiting
Research Site
Genova, 16132
- Active, not recruiting
Research Site
Grosseto, 58100
- Active, not recruiting
Research Site
Milan, 20132
- Active, not recruiting
Research Site
Milan, 20141
- Active, not recruiting
Research Site
Modena, 41125
- Active, not recruiting
Research Site
Naples, 80131
- Withdrawn
Research Site
Naples, 80131
- Active, not recruiting
Research Site
Pisa, 56126
- Active, not recruiting
Research Site
Reggio Emilia, 42122
- Active, not recruiting
Research Site
Roma, 00168
- Active, not recruiting
Research Site
Rozzano, 20089
- Active, not recruiting
Research Site
Turin, 10128
Turkey (Türkiye)16 sites
- Active, not recruiting
Research Site
Ankara, 06100
- Active, not recruiting
Research Site
Ankara, 06200
- Active, not recruiting
Research Site
Ankara, 06520
- Withdrawn
Research Site
Ankara, 06620
- Withdrawn
Research Site
Ankara, 6800
- Active, not recruiting
Research Site
Aydin, 9010
- Withdrawn
Research Site
Bursa, 16059
- Active, not recruiting
Research Site
Dinar, 03400
- Withdrawn
Research Site
Istanbul, 34010
- Withdrawn
Research Site
Istanbul, 34218
- Active, not recruiting
Research Site
Istanbul, 34899
- Withdrawn
Research Site
Izmir, 35120
- Active, not recruiting
Research Site
Izmir, 35150
- Active, not recruiting
Research Site
Izmir, 35530
- Active, not recruiting
Research Site
Izmir, 35575
- Active, not recruiting
Research Site
Samsun, 55200
Mexico15 sites
- Active, not recruiting
Research Site
Aguascalientes, 20230
- Active, not recruiting
Research Site
Alc. Cuauhtémoc, 06100
- Withdrawn
Research Site
Colonia Lindavista, 7300
- Active, not recruiting
Research Site
Mérida, 97300
- Withdrawn
Research Site
México, 14080
- Active, not recruiting
Research Site
México, 14080
- Active, not recruiting
Research Site
México, 6700
- Active, not recruiting
Research Site
Mexico City, 03310
- Withdrawn
Research Site
Monterrey, 64460
- Active, not recruiting
Research Site
Monterrey, 64460
- Withdrawn
Research Site
Monterrey, 64570
- Withdrawn
Research Site
San Luis Potosí City, 78250
- Active, not recruiting
Research Site
Toluca, 50180
- Active, not recruiting
Research Site
Veracruz, 91900
- Active, not recruiting
Research Site
Veracruz, 91910
Romania15 sites
- Withdrawn
Research Site
Baia Mare, 430031
- Active, not recruiting
Research Site
Brasov, 500283
- Terminated
Research Site
Cluj-Napoca, 400015
- Active, not recruiting
Research Site
Cluj-Napoca, 400641
- Terminated
Research Site
Constanța, 900591
- Active, not recruiting
Research Site
Craiova, 200094
- Active, not recruiting
Research Site
Craiova, 200347
- Active, not recruiting
Research Site
Craiova, 200385
- Active, not recruiting
Research Site
Floreşti, 407280
- Active, not recruiting
Research Site
Iași, 700106
- Withdrawn
Research Site
Oradea, 410167
- Active, not recruiting
Research Site
Piteşti, 110283
- Active, not recruiting
Research Site
Sibiu, 550245
- Withdrawn
Research Site
Timișoara, 300166
- Active, not recruiting
Research Site
Timișoara, 300239
United Kingdom15 sites
- Active, not recruiting
Research Site
Brighton, BN2 5BE
- Active, not recruiting
Research Site
Burton-on-Trent, DE13 0RB
- Active, not recruiting
Research Site
Cambridge, CB2 0QQ
- Active, not recruiting
Research Site
Derby, DE22 3NE
- Active, not recruiting
Research Site
Edinburgh, EH4 2XU
- Withdrawn
Research Site
Guildford
- Active, not recruiting
Research Site
Ipswich, IP4 5PD
- Withdrawn
Research Site
Keighley, BD20 6TD
- Terminated
Research Site
London, SE1 9RT
- Active, not recruiting
Research Site
London, SW3 6JJ
- Active, not recruiting
Research Site
Manchester, M20 4BX
- Active, not recruiting
Research Site
Oxford, OX3 7LJ
- Withdrawn
Research Site
Peterborough, PE3 9GZ
- Withdrawn
Research Site
Stoke-on-Trent, ST4 6QG
- Active, not recruiting
Research Site
Sutton, SM2 5PT
Canada14 sites
- Active, not recruiting
Research Site
Barrie, Ontario, L4M 6M2
- Withdrawn
Research Site
Calgary, Alberta, T2N 4N2
- Active, not recruiting
Research Site
Chicoutimi, Quebec, G7H 5H6
- Active, not recruiting
Research Site
Greenfield Park, Quebec, J4V 2H1
- Active, not recruiting
Research Site
Kelowna, British Columbia, V1Y 5L3
- Active, not recruiting
Research Site
Montreal, Quebec, H1T 2M4
- Active, not recruiting
Research Site
Montreal, Quebec, H2X 3E4
- Active, not recruiting
Research Site
Montreal, Quebec, H4A 3J1
- Withdrawn
Research Site
Ottawa, Ontario, K1H 8L6
- Active, not recruiting
Research Site
Saint-Jérôme, Quebec, J7Z 5T3
- Active, not recruiting
Research Site
Sault Ste. Marie, Ontario, P6A 0A8
- Active, not recruiting
Research Site
Toronto, Ontario, M5G 1X5
- Active, not recruiting
Research Site
Windsor, Ontario, N8W 2X3
- Active, not recruiting
Research Site
Winnipeg, Manitoba, R3E 0V9
Greece13 sites
- Withdrawn
Research Site
Athens, 115 28
- Active, not recruiting
Research Site
Athens, 11528
- Active, not recruiting
Research Site
Athens, 15123
- Active, not recruiting
Research Site
Athens, 18537
- Active, not recruiting
Research Site
Chaïdári, 124 62
- Active, not recruiting
Research Site
Heraklion, 71110
- Active, not recruiting
Research Site
Ioannina, 45500
- Active, not recruiting
Research Site
Rio, 265 04
- Active, not recruiting
Research Site
Thessaloniki, 546 39
- Active, not recruiting
Research Site
Thessaloniki, 54631
- Terminated
Research Site
Thessaloniki, 54645
- Active, not recruiting
Research Site
Thessaloniki, 54645
- Active, not recruiting
Research Site
Thessaloniki, 57001
South Korea13 sites
- Active, not recruiting
Research Site
Busan, 48108
- Active, not recruiting
Research Site
Daegu, 42601
- Withdrawn
Research Site
Donggu, 44033
- Active, not recruiting
Research Site
Goyang-si, 10408
- Active, not recruiting
Research Site
Jeonnam, 58128
- Withdrawn
Research Site
Seongbuk-Gu, 2841
- Active, not recruiting
Research Site
Seoul, 03080
- Active, not recruiting
Research Site
Seoul, 03722
- Active, not recruiting
Research Site
Seoul, 06273
- Active, not recruiting
Research Site
Seoul, 06351
- Active, not recruiting
Research Site
Seoul, 06591
- Terminated
Research Site
Seoul, 08308
- Active, not recruiting
Research Site
Seoul, 158-710
Hungary12 sites
- Active, not recruiting
Research Site
Budapest, 1083
- Withdrawn
Research Site
Budapest, 1106
- Active, not recruiting
Research Site
Budapest, 1115
- Active, not recruiting
Research Site
Budapest, 1122
- Active, not recruiting
Research Site
Debrecen, 4032
- Active, not recruiting
Research Site
Győr, 9024
- Active, not recruiting
Research Site
Gyula, 5700
- Active, not recruiting
Research Site
Kaposvár, 7400
- Active, not recruiting
Research Site
Miskolc, 3526
- Active, not recruiting
Research Site
Nyíregyháza, 4400
- Active, not recruiting
Research Site
Szekszárd, 7100
- Withdrawn
Research Site
Szolnok, 5000
Poland11 sites
- Active, not recruiting
Research Site
Bialystok, 15-027
- Active, not recruiting
Research Site
Grudziądz, 86-300
- Active, not recruiting
Research Site
Koszalin, 75-581
- Active, not recruiting
Research Site
Lodz, 90-302
- Active, not recruiting
Research Site
Lublin, 20-718
- Active, not recruiting
Research Site
Opole, 45-061
- Active, not recruiting
Research Site
Poznan, 61-485
- Active, not recruiting
Research Site
Racibórz, 47-400
- Active, not recruiting
Research Site
Rzeszów, 35-021
- Active, not recruiting
Research Site
Warsaw, 02-781
- Active, not recruiting
Research Site
Wieliszew, 05-135
South Africa11 sites, 1 recruiting
- Active, not recruiting
Research Site
Bloemfontein, 9301
- Withdrawn
Research Site
Bloemfontein, 9301
- Terminated
Research Site
eManzimtoti, 4126
- Withdrawn
Research Site
George, 6529
- Active, not recruiting
Research Site
George, 6529
- Recruiting
Research Site
Johannesburg, 2193
- Terminated
Research Site
Johannesburg, 2196
- Withdrawn
Research Site
Pietermaritzburg, 3201
- Withdrawn
Research Site
Pretoria, 0084
- Active, not recruiting
Research Site
Pretoria, 31
- Active, not recruiting
Research Site
Soweto, 2193
Colombia10 sites
- Withdrawn
Research Site
Barranquilla, 080020
- Withdrawn
Research Site
Barranquilla, 80020
- Withdrawn
Research Site
Bogotá, 110221
- Withdrawn
Research Site
Bogotá, 111511
- Withdrawn
Research Site
Cali, 760042
- Withdrawn
Research Site
Floridablanca, 681004
- Withdrawn
Research Site
Medellín, 50030
- Withdrawn
Research Site
Montería, 23001
- Withdrawn
Research Site
Pereira
- Withdrawn
Research Site
Valledupar, 200001
Israel10 sites
- Active, not recruiting
Research Site
Afula, 1834111
- Active, not recruiting
Research Site
Ashdod, 7747629
- Active, not recruiting
Research Site
Haifa, 31096
- Active, not recruiting
Research Site
Jerusalem, 00000
- Terminated
Research Site
Jerusalem, 9103102
- Active, not recruiting
Research Site
Kfar Saba, 4428164
- Active, not recruiting
Research Site
Nahariya, 22100
- Active, not recruiting
Research Site
Ramat Gan, 52621
- Active, not recruiting
Research Site
Rehovot, 7661041
- Withdrawn
Research Site
Tel Aviv, 69710
Malaysia10 sites
- Active, not recruiting
Research Site
George Town, 10350
- Active, not recruiting
Research Site
George Town, 10450
- Active, not recruiting
Research Site
Johor Bahru, 81100
- Terminated
Research Site
Kota Bharu, 16150
- Active, not recruiting
Research Site
Kuala Lumpur, 50300
- Active, not recruiting
Research Site
Kuala Lumpur, 50450
- Active, not recruiting
Research Site
Kuala Lumpur, 50603
- Active, not recruiting
Research Site
Kuching, 93586
- Active, not recruiting
Research Site
Malacca, 75000
- Active, not recruiting
Research Site
Sabak Bernam, 88996
Peru10 sites
- Withdrawn
Research Site
Arequipa, 04001
- Active, not recruiting
Research Site
Arequipa, 4001
- Active, not recruiting
Research Site
Arequipa, AREQUIPA01
- Withdrawn
Research Site
Callao, 7021
- Withdrawn
Research Site
La Libertad, 13013
- Withdrawn
Research Site
Lima, 0051
- Active, not recruiting
Research Site
Lima, 15076
- Terminated
Research Site
Lima, Lima 32
- Withdrawn
Research Site
Lima, Lima 34
- Active, not recruiting
Research Site
Trujillo
Portugal10 sites
- Active, not recruiting
Research Site
Amadora, 2720-276
- Active, not recruiting
Research Site
Braga, 4710-243
- Active, not recruiting
Research Site
Guimarães, 4835-044
- Active, not recruiting
Research Site
Lisbon, 1649-035
- Active, not recruiting
Research Site
Lisbon, 1998-018
- Active, not recruiting
Research Site
Matosinhos Municipality, 4454-509
- Active, not recruiting
Research Site
Porto, 4100-180
- Active, not recruiting
Research Site
Porto, 4200-072
- Active, not recruiting
Research Site
Porto, 4200-319
- Active, not recruiting
Research Site
Vila Nova de Gaia, 4434-502
Bulgaria9 sites
- Active, not recruiting
Research Site
Dobrich, 9300
- Withdrawn
Research Site
Plovdiv, 4002
- Active, not recruiting
Research Site
Plovdiv, 4004
- Active, not recruiting
Research Site
Sofia, 1330
- Active, not recruiting
Research Site
Sofia, 1407
- Withdrawn
Research Site
Sofia, 1431
- Withdrawn
Research Site
Sofia, 1606
- Terminated
Research Site
Sofia, 1784
- Withdrawn
Research Site
Vratsa, 3000
Chile9 sites
- Active, not recruiting
Research Site
Concepción, 4070196
- Active, not recruiting
Research Site
La Serena, 1720430
- Active, not recruiting
Research Site
Port Montt, 5500243
- Active, not recruiting
Research Site
Santiago, 8150215
- Active, not recruiting
Research Site
Santiago, 8330032
- Active, not recruiting
Research Site
Santiago, 8330336
- Active, not recruiting
Research Site
Talca, 3460000
- Active, not recruiting
Research Site
Temuco, 4780000
- Active, not recruiting
Research Site
Viña del Mar, 2520000
Australia8 sites
- Active, not recruiting
Research Site
Birtinya, 4575
- Active, not recruiting
Research Site
Concord, 2139
- Withdrawn
Research Site
Nedlands, 6009
- Active, not recruiting
Research Site
Nedlands, 6009
- Active, not recruiting
Research Site
Randwick, 2031
- Withdrawn
Research Site
Tweed Heads, 2485
- Active, not recruiting
Research Site
Waratah, 2298
- Active, not recruiting
Research Site
Wendouree, 3355
Austria8 sites
- Active, not recruiting
Research Site
Graz, 8036
- Active, not recruiting
Research Site
Kufstein, 6330
- Withdrawn
Research Site
Ried, 4910
- Active, not recruiting
Research Site
Sankt Veit an der Glan, 9300
- Active, not recruiting
Research Site
Vienna, 1090
- Withdrawn
Research Site
Vienna, 1180
- Active, not recruiting
Research Site
Wein, 1130
- Active, not recruiting
Research Site
Wels, 4600
Belgium8 sites, 1 recruiting
- Active, not recruiting
Research Site
Brussels, 1090
- Recruiting
Research Site
Edegem, 2650
- Active, not recruiting
Research Site
Ghent, 9000
- Active, not recruiting
Research Site
Leuven, 8500
- Active, not recruiting
Research Site
Liège, 4000
- Active, not recruiting
Research Site
Ottignies, 1340
- Active, not recruiting
Research Site
Wilrijk, 2610
- Active, not recruiting
Research Site
Yvoir, 5530
Serbia8 sites
- Active, not recruiting
Research Site
Belgrade, 11000
- Active, not recruiting
Research Site
Belgrade, 11010
- Active, not recruiting
Research Site
Belgrade, 11080
- Active, not recruiting
Research Site
Kamenitz, 21204
- Active, not recruiting
Research Site
Kragujevac, 34000
- Active, not recruiting
Research Site
Niš, 18000
- Active, not recruiting
Research Site
Valjevo, 14000
- Active, not recruiting
Research Site
Zrenjanin, 23000
Taiwan8 sites
- Active, not recruiting
Research Site
Hsinchu, 300
- Active, not recruiting
Research Site
Kaohsiung City, 82445
- Withdrawn
Research Site
Taichung, 40447
- Active, not recruiting
Research Site
Tainan, 70403
- Active, not recruiting
Research Site
Tainan, 710
- Active, not recruiting
Research Site
Taipei, 10002
- Active, not recruiting
Research Site
Taipei, 110
- Active, not recruiting
Research Site
Taipei, 11259
Philippines7 sites
- Active, not recruiting
Research Site
Bacolod, 6100
- Active, not recruiting
Research Site
Cebu, 6000
- Withdrawn
Research Site
Iloilo City, 5000
- Withdrawn
Research Site
Manila, 1000
- Withdrawn
Research Site
Quezon City, 0870
- Terminated
Research Site
Quezon City, 1101
- Active, not recruiting
Research Site
Quezon City, 1112
Thailand7 sites
- Active, not recruiting
Research Site
Bangkok, 10400
- Active, not recruiting
Research Site
Bangkok, 10700
- Active, not recruiting
Research Site
Khon Kaen, 40002
- Active, not recruiting
Research Site
Phisanulok, 65000
- Active, not recruiting
Research Site
Phitsanulok, 65000
- Active, not recruiting
Research Site
Rachathewi, 10400
- Active, not recruiting
Research Site
Songkhla, 90110
Czechia6 sites
- Active, not recruiting
Research Site
Hořovice, 268 31
- Active, not recruiting
Research Site
Pardubice, 532 03
- Active, not recruiting
Research Site
Prague, 140 00
- Withdrawn
Research Site
Prague, 15006
- Withdrawn
Research Site
Pragues, 18081
- Withdrawn
Research Site
Příbram, 261 01
Netherlands6 sites
- Active, not recruiting
Research Site
Dirksland, 3247 BW
- Active, not recruiting
Research Site
Geleen, 6162 BG
- Withdrawn
Research Site
Groningen, 9728 NT
- Withdrawn
Research Site
Hoofddorp, 2134 TM
- Withdrawn
Research Site
Rotterdam, 3079 DZ
- Active, not recruiting
Research Site
Rotterdam, 3083 AN
Georgia5 sites
- Active, not recruiting
Research Site
Batumi, 6400
- Active, not recruiting
Research Site
Tbilisi, 0179
- Active, not recruiting
Research Site
Tbilisi, 112
- Withdrawn
Research Site
Tbilisi, 160
- Withdrawn
Research Site
Tbilisi, 186
Singapore4 sites
- Active, not recruiting
Research Site
Singapore, 119074
- Active, not recruiting
Research Site
Singapore, 228510
- Active, not recruiting
Research Site
Singapore, 308433
- Active, not recruiting
Research Site
Singapore, 329563
Vietnam4 sites
- Active, not recruiting
Research Site
Hanoi, 100000
- Active, not recruiting
Research Site
Ho Chi Minh City, 700000
- Active, not recruiting
Research Site
Ho Chi Minh City, 70000
- Withdrawn
Research Site
Huế, 530000
About this study
Official title: CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.
Read the detailed description
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months. The eligible patients must have intermediate or high risk of recurrence, as defined by specified clinical and biologic criteria. Prior use of CDK4/6 inhibitors is permitted. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs).
Patients will be followed for 10 years from randomization of the last patient.
- Conditions
- Breast Cancer, Early Breast Cancer
- Being tested
- Camizestrant, Tamoxifen, Anastrozole, Letrozole, Exemestane
- Keywords
- ER+, HER2-, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamizestrantDrug
Also called AZD9833
Camizestrant. Experimental. Administered orally
TamoxifenDrug
Tamoxifen. Comparator. Administered per local approved label
AnastrozoleDrug
Anastrozole. Comparator. Administered per local approved label
LetrozoleDrug
Letrozole. Comparator. Administered per local approved label
ExemestaneDrug
Exemestane. Comparator. Administered per local approved label
| Study group | Role | What they receive |
|---|---|---|
| Arm A: standard endocrine therapy of investigator´s choice | Active comparator | Continue standard endocrine therapy of investigator's choice (aromatase inhibitors [AI; exemestane, letrozole, anastrozole] or tamoxifen) Receives: Drug: Tamoxifen; Drug: Anastrozole; Drug: Letrozole; Drug: Exemestane |
| Arm B: camizestrant | Experimental | Camizestrant Receives: Drug: Camizestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive breast cancer-free survival (IBCFS)
IBCFS is defined as time from randomisation until date of first occurrence of:
- Invasive ipsilateral breast tumour recurrence (invasive IBTR)
- Locoregional invasive breast cancer recurrence
- Distant recurrence
- Invasive contralateral breast cancer
- Death attributable to any cause.
Measured: Up to 10 years
Secondary outcomes (14)
Invasive disease-free survival (IDFS)
IDFS is defined as time from randomisation until date of first occurrence of one of the following events:
- Invasive ipsilateral breast tumor recurrence (invasive IBTR)
- Locoregional invasive breast cancer recurrence
- Distant recurrence
- Invasive contralateral breast cancer
- Second primary non-breast invasive cancer
- Death attributable to any cause.
Measured: Up to 10 years
Distant relapse-free survival (DRFS)
DRFS is defined as time from randomisation until date of first distant recurrence or death from any cause, whichever occurs first.
Measured: Up to 10 years
Overall survival (OS)
OS is defined as time from randomisation until death from any cause.
Measured: Up to 10 years
Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0)
Measured: Until 28 days after the final dose of study treatment (up to 5 years)
Absolute and percent change from baseline in Clinical Laboratory Parameters
Measured: Until 28 days after the final dose of study treatment (up to 5 years)
Absolute and percent change from baseline in Vital Sign Parameters
Measured: Until 28 days after the final dose of study treatment (up to 5 years)
Change from baseline of arthralgia as measured by the EORTC-IL-194 (European Organisation for Research and Treatment of Cancer) item 10. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
Measured: Until 28 days after the final dose of study treatment (up to 5 years)
Change from baseline of hot flush as measured by the EORTC-IL-194 item 4. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
Measured: Until 28 days after the final dose of study treatment (up to 5 years)
Change from baseline of vaginal dryness as measured by the EORTC-IL-194 item 15. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
Measured: Until 28 days after the final dose of study treatment (up to 5 years)
Proportion of patients experiencing each level of symptomatic AEs of arthralgia as measured by the EORTC-IL-194 item 10. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
Measured: Until 28 days after the final dose of study treatment (up to 5 years)
Proportion of patients experiencing each level of symptomatic AEs of hot flush as measured by the EORTC-IL-194 item 4. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
Measured: Until 28 days after the final dose of study treatment (up to 5 years)
Proportion of patients experiencing each level of symptomatic AEs of vaginal dryness as measured by the EORTC-IL-194 item 15. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
Measured: Until 28 days after the final dose of study treatment (up to 5 years)
Change from baseline and TTD (time to deterioration ) of health-related QoL (quality of life) as measured by the 2 global QoL items from the EORTC-QLQ-C30 items 11 and 12. EORTC-QLQ-C30 uses 0 - 4 scale (higher score is worse)
Measured: Until 28 days after the final dose of study treatment (up to 5 years)
Pharmacokinetics (PK)
- Plasma concentrations of camizestrant pre-dose (Ctrough)( trough concentration)
Measured: Until 6 months from treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start31 Mar 2023
- Primary completion20 Apr 2027 (estimated)
- Study completion29 May 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer, Early Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomised in a 1:1 ratio to one of the following arms: * Arm A: Continue standard ET of investigator's choice (aromatase inhibitors \[AI; exemestane, letrozole, anastrozole\] or tamoxifen) * Arm B: Camizestrant
- Masking
- None (open label)
- Enrolment
- 4,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774951
- Sponsor's protocol ID
- D8531C00002
- Other IDs
- 2022-501024-20-00
- Acronym
- CAMBRIA-1
- Status last verified
- Oct 2026
- First submitted
- 16 Feb 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
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.
PubMed 40017004