A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy (CAMBRIA-1)

May 7, 2026 updated by: AstraZeneca

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Estimated)

4300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Buenos Aires, Argentina, C1430EGF
        • Withdrawn
        • Research Site
      • CABA, Argentina, C1119ACN
        • Active, not recruiting
        • Research Site
      • Capital Federal, Argentina, C1417DTB
        • Active, not recruiting
        • Research Site
      • Ciudad Autónoma Buenos Aires, Argentina, 1125
        • Active, not recruiting
        • Research Site
      • Ciudad de Buenos Aires, Argentina, 1280
        • Active, not recruiting
        • Research Site
      • Ciudad de Buenos Aires, Argentina, C1118AAT
        • Active, not recruiting
        • Research Site
      • Ciudad de Buenos Aires, Argentina, C1426ANZ
        • Active, not recruiting
        • Research Site
      • Córdoba, Argentina, 5000
        • Active, not recruiting
        • Research Site
      • Córdoba, Argentina, 5001
        • Active, not recruiting
        • Research Site
      • La Plata, Argentina, 1900
        • Active, not recruiting
        • Research Site
      • Mar del Plata, Argentina, 7600
        • Active, not recruiting
        • Research Site
      • Salta, Argentina, A4400EMI
        • Withdrawn
        • Research Site
      • San Juan, Argentina, 5400
        • Active, not recruiting
        • Research Site
      • San Miguel de Tucumán, Argentina, 4000
        • Active, not recruiting
        • Research Site
      • San Miguel de Tucumán, Argentina, T4000IAK
        • Active, not recruiting
        • Research Site
      • Viedma, Argentina, R8500ACE
        • Active, not recruiting
        • Research Site
      • Birtinya, Australia, 4575
        • Active, not recruiting
        • Research Site
      • Concord, Australia, 2139
        • Active, not recruiting
        • Research Site
      • Nedlands, Australia, 6009
        • Active, not recruiting
        • Research Site
      • Nedlands, Australia, 6009
        • Withdrawn
        • Research Site
      • Randwick, Australia, 2031
        • Active, not recruiting
        • Research Site
      • Tweed Heads, Australia, 2485
        • Withdrawn
        • Research Site
      • Waratah, Australia, 2298
        • Active, not recruiting
        • Research Site
      • Wendouree, Australia, 3355
        • Active, not recruiting
        • Research Site
      • Graz, Austria, 8036
        • Active, not recruiting
        • Research Site
      • Kufstein, Austria, 6330
        • Active, not recruiting
        • Research Site
      • Ried, Austria, 4910
        • Withdrawn
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      • Sankt Veit an der Glan, Austria, 9300
        • Active, not recruiting
        • Research Site
      • Vienna, Austria, 1090
        • Active, not recruiting
        • Research Site
      • Vienna, Austria, 1180
        • Withdrawn
        • Research Site
      • Wein, Austria, 1130
        • Active, not recruiting
        • Research Site
      • Wels, Austria, 4600
        • Active, not recruiting
        • Research Site
      • Brussels, Belgium, 1090
        • Active, not recruiting
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      • Edegem, Belgium, 2650
        • Recruiting
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      • Ghent, Belgium, 9000
        • Active, not recruiting
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      • Leuven, Belgium, 8500
        • Active, not recruiting
        • Research Site
      • Liège, Belgium, 4000
        • Active, not recruiting
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      • Ottignies, Belgium, 1340
        • Active, not recruiting
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      • Wilrijk, Belgium, 2610
        • Active, not recruiting
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      • Yvoir, Belgium, 5530
        • Active, not recruiting
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      • Alfenas, Brazil, 37130-000
        • Active, not recruiting
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      • Belo Horizonte, Brazil, 30150-274
        • Active, not recruiting
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      • Belo Horizonte, Brazil, 30130-100
        • Active, not recruiting
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      • Brasília, Brazil, 71681-603
        • Active, not recruiting
        • Research Site
      • Brasília, Brazil, 70390-700
        • Withdrawn
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      • Chapecó, Brazil, 89812-220
        • Active, not recruiting
        • Research Site
      • Cuiabá, Brazil, 78040-400
        • Terminated
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      • Curitiba, Brazil, 81520-060
        • Recruiting
        • Research Site
      • Curitiba, Brazil, 80810-050
        • Active, not recruiting
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      • Fortaleza, Brazil, 60430-230
        • Active, not recruiting
        • Research Site
      • Fortaleza, Brazil, 60170-170
        • Active, not recruiting
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      • Lajeado, Brazil, 95900000
        • Active, not recruiting
        • Research Site
      • Londrina, Brazil, 86015-520
        • Recruiting
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      • Natal, Brazil, 59075-740
        • Active, not recruiting
        • Research Site
      • Niterói, Brazil, 24020-096
        • Active, not recruiting
        • Research Site
      • Piracicaba, Brazil, 13419-155
        • Active, not recruiting
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      • Porto Alegre, Brazil, 90035-903
        • Active, not recruiting
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      • Porto Alegre, Brazil, 90050-170
        • Active, not recruiting
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      • Porto Alegre, Brazil, 90035-001
        • Active, not recruiting
        • Research Site
      • Porto Alegre, Brazil, 90880-480
        • Active, not recruiting
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      • Pouso Alegre, Brazil, 37554-216
        • Active, not recruiting
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      • Recife, Brazil, 50070-070
        • Active, not recruiting
        • Research Site
      • Ribeirão Preto, Brazil, 14051-140
        • Active, not recruiting
        • Research Site
      • Rio de Janeiro, Brazil, 20560-120
        • Active, not recruiting
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      • Rio de Janeiro, Brazil, 22250-905
        • Active, not recruiting
        • Research Site
      • Rio de Janeiro, Brazil, 22290-160
        • Recruiting
        • Research Site
      • Salvador, Brazil, 41253-190
        • Active, not recruiting
        • Research Site
      • Salvador, Brazil, 40110-060
        • Withdrawn
        • Research Site
      • São Paulo, Brazil, 08270-070
        • Active, not recruiting
        • Research Site
      • São Paulo, Brazil, 01323-001
        • Active, not recruiting
        • Research Site
      • São Paulo, Brazil, 01317-001
        • Active, not recruiting
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      • São Paulo, Brazil, 01508-010
        • Active, not recruiting
        • Research Site
      • São Paulo, Brazil, 01509-900
        • Active, not recruiting
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      • São Paulo, Brazil, 01236-030
        • Active, not recruiting
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      • Taubaté, Brazil, 12030-200
        • Recruiting
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      • Três Lagoas, Brazil, 79601-001
        • Active, not recruiting
        • Research Site
      • Vitória, Brazil, 29055-450
        • Active, not recruiting
        • Research Site
      • Dobrich, Bulgaria, 9300
        • Active, not recruiting
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      • Plovdiv, Bulgaria, 4002
        • Withdrawn
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      • Plovdiv, Bulgaria, 4004
        • Active, not recruiting
        • Research Site
      • Sofia, Bulgaria, 1431
        • Withdrawn
        • Research Site
      • Sofia, Bulgaria, 1606
        • Withdrawn
        • Research Site
      • Sofia, Bulgaria, 1330
        • Active, not recruiting
        • Research Site
      • Sofia, Bulgaria, 1407
        • Active, not recruiting
        • Research Site
      • Sofia, Bulgaria, 1784
        • Terminated
        • Research Site
      • Vratsa, Bulgaria, 3000
        • Withdrawn
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Withdrawn
        • Research Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • Active, not recruiting
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    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Active, not recruiting
        • Research Site
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Active, not recruiting
        • Research Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Withdrawn
        • Research Site
      • Sault Ste. Marie, Ontario, Canada, P6A 0A8
        • Active, not recruiting
        • Research Site
      • Toronto, Ontario, Canada, M5G 1X5
        • Active, not recruiting
        • Research Site
      • Windsor, Ontario, Canada, N8W 2X3
        • Active, not recruiting
        • Research Site
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Active, not recruiting
        • Research Site
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Active, not recruiting
        • Research Site
      • Montreal, Quebec, Canada, H1T 2M4
        • Active, not recruiting
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      • Montreal, Quebec, Canada, H2X 3E4
        • Active, not recruiting
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      • Montreal, Quebec, Canada, H4A 3J1
        • Active, not recruiting
        • Research Site
      • Saint-Jérôme, Quebec, Canada, J7Z 5T3
        • Active, not recruiting
        • Research Site
      • Concepción, Chile, 4070196
        • Active, not recruiting
        • Research Site
      • La Serena, Chile, 1720430
        • Active, not recruiting
        • Research Site
      • Port Montt, Chile, 5500243
        • Active, not recruiting
        • Research Site
      • Santiago, Chile, 8150215
        • Active, not recruiting
        • Research Site
      • Santiago, Chile, 8330032
        • Active, not recruiting
        • Research Site
      • Santiago, Chile, 8330336
        • Active, not recruiting
        • Research Site
      • Talca, Chile, 3460000
        • Active, not recruiting
        • Research Site
      • Temuco, Chile, 4780000
        • Active, not recruiting
        • Research Site
      • Viña del Mar, Chile, 2520000
        • Active, not recruiting
        • Research Site
      • Baoding, China, 071000
        • Active, not recruiting
        • Research Site
      • Beijing, China, 100021
        • Withdrawn
        • Research Site
      • Beijing, China
        • Withdrawn
        • Research Site
      • Beijing, China, 100142
        • Active, not recruiting
        • Research Site
      • Beijing, China, 100044
        • Active, not recruiting
        • Research Site
      • Beijing, China, 100005
        • Active, not recruiting
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      • Changchun, China, 130021
        • Active, not recruiting
        • Research Site
      • Changsha, China, 410008
        • Active, not recruiting
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      • Chengdu, China, 610041
        • Active, not recruiting
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      • Chengdu, China, 610072
        • Active, not recruiting
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      • Chengdu, China, 610000
        • Active, not recruiting
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      • Chifeng, China, 024000
        • Active, not recruiting
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      • Dalian, China, 116023
        • Active, not recruiting
        • Research Site
      • Foshan, China, 528000
        • Active, not recruiting
        • Research Site
      • Fuzhou, China, 350001
        • Withdrawn
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      • Fuzhou, China, 350011
        • Active, not recruiting
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      • Guangzhou, China, 510060
        • Active, not recruiting
        • Research Site
      • Guangzhou, China, 510120
        • Withdrawn
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      • Guangzhou, China, 510168
        • Withdrawn
        • Research Site
      • Haikou, China, 570311
        • Active, not recruiting
        • Research Site
      • Haikou, China, 570102
        • Withdrawn
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      • Hangzhou, China, 310003
        • Active, not recruiting
        • Research Site
      • Hangzhou, China, 310020
        • Active, not recruiting
        • Research Site
      • Hangzhou, China, 310022
        • Active, not recruiting
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      • Hangzhou, China, 310009
        • Active, not recruiting
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      • Harbin, China, 150081
        • Active, not recruiting
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      • Hefei, China, 230001
        • Active, not recruiting
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      • Hefei, China, 230601
        • Active, not recruiting
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      • Hefei, China, 230012
        • Active, not recruiting
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      • Hohhot, China, 010010
        • Active, not recruiting
        • Research Site
      • Huangpu District, China, 200025
        • Withdrawn
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      • Jinan, China, 2501117
        • Active, not recruiting
        • Research Site
      • Lanzhou, China, 730050
        • Active, not recruiting
        • Research Site
      • Liuzhou, China, 545005
        • Active, not recruiting
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      • Nanchang, China, 330009
        • Active, not recruiting
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      • Nanjing, China, 210029
        • Active, not recruiting
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      • Nanjing, China, 210009
        • Active, not recruiting
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      • Nanning, China, 530021
        • Active, not recruiting
        • Research Site
      • Nanning, China, 530021
        • Withdrawn
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      • Neijiang, China, 641000
        • Active, not recruiting
        • Research Site
      • Qingdao, China, 266100
        • Withdrawn
        • Research Site
      • Shanghai, China, 200032
        • Withdrawn
        • Research Site
      • Shanghai, China, 200032
        • Active, not recruiting
        • Research Site
      • Shanghai, China, 200127
        • Active, not recruiting
        • Research Site
      • Shantou, China, 515031
        • Withdrawn
        • Research Site
      • Shaoguan, China, 512027
        • Active, not recruiting
        • Research Site
      • Shenyang, China, 110001
        • Withdrawn
        • Research Site
      • Shenyang, China, 110016
        • Active, not recruiting
        • Research Site
      • Shijiazhuang, China, 050020
        • Active, not recruiting
        • Research Site
      • Suining, China, 629000
        • Active, not recruiting
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      • Suzhou, China, 215006
        • Active, not recruiting
        • Research Site
      • Taiyuan, China, 030000
        • Withdrawn
        • Research Site
      • Taizhou, China, 317000
        • Active, not recruiting
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      • Tianjin, China, 300060
        • Active, not recruiting
        • Research Site
      • Weifang, China, 261000
        • Active, not recruiting
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      • Wuhan, China, 430079
        • Active, not recruiting
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      • Wuhan, China, 430022
        • Active, not recruiting
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      • Wuhan, China, 430070
        • Active, not recruiting
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      • Xiangfan, China, 441021
        • Active, not recruiting
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      • Xining, China, 810001
        • Withdrawn
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      • Xinxiang, China, 453100
        • Active, not recruiting
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      • Xuzhou, China, 221000
        • Active, not recruiting
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      • Xuzhou, China, 221009
        • Active, not recruiting
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      • Yanji, China, 133000
        • Active, not recruiting
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      • Yantai, China, 264000
        • Active, not recruiting
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      • Zhengzhou, China, 450052
        • Active, not recruiting
        • Research Site
      • Barranquilla, Colombia, 80020
        • Withdrawn
        • Research Site
      • Barranquilla, Colombia, 080020
        • Withdrawn
        • Research Site
      • Bogotá, Colombia, 110221
        • Withdrawn
        • Research Site
      • Bogotá, Colombia, 111511
        • Withdrawn
        • Research Site
      • Cali, Colombia, 760042
        • Withdrawn
        • Research Site
      • Floridablanca, Colombia, 681004
        • Withdrawn
        • Research Site
      • Medellín, Colombia, 50030
        • Withdrawn
        • Research Site
      • Montería, Colombia, 23001
        • Withdrawn
        • Research Site
      • Pereira, Colombia
        • Withdrawn
        • Research Site
      • Valledupar, Colombia, 200001
        • Withdrawn
        • Research Site
      • Hořovice, Czechia, 268 31
        • Active, not recruiting
        • Research Site
      • Pardubice, Czechia, 532 03
        • Active, not recruiting
        • Research Site
      • Prague, Czechia, 140 00
        • Active, not recruiting
        • Research Site
      • Prague, Czechia, 15006
        • Withdrawn
        • Research Site
      • Pragues, Czechia, 18081
        • Withdrawn
        • Research Site
      • Příbram, Czechia, 261 01
        • Withdrawn
        • Research Site
      • Angers, France, 49055
        • Withdrawn
        • Research Site
      • Argenteuil, France, 95100
        • Active, not recruiting
        • Research Site
      • Avignon, France, 84918
        • Active, not recruiting
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      • Bordeaux, France, 33000
        • Active, not recruiting
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      • Bordeaux, France, 33077
        • Active, not recruiting
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      • Bourg-en-Bresse, France, 01012
        • Withdrawn
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      • Caen, France, 14076
        • Active, not recruiting
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      • Cholet, France, 49300
        • Active, not recruiting
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      • Clermont-Ferrand, France, 63011
        • Withdrawn
        • Research Site
      • Dijon, France, 21079
        • Withdrawn
        • Research Site
      • Epagny Metz-Tessy, France, 74370
        • Withdrawn
        • Research Site
      • Lille, France, 59000
        • Active, not recruiting
        • Research Site
      • Lorient, France, 56322
        • Active, not recruiting
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      • Lyon, France, 69008
        • Active, not recruiting
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      • Marseille, France, 13273
        • Active, not recruiting
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      • Metz, France, 57085
        • Active, not recruiting
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      • Montpellier, France, 34070
        • Active, not recruiting
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      • Montpellier, France, 34298
        • Active, not recruiting
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      • Nantes, France, 44202
        • Active, not recruiting
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      • Nîmes, France, 30029
        • Active, not recruiting
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      • Paris, France, 75013
        • Active, not recruiting
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      • Paris, France, 75010
        • Withdrawn
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      • Pierre-Bénite, France, 69310
        • Active, not recruiting
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      • Plerin SUR MER, France, 22190
        • Active, not recruiting
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      • Poitiers, France, 86021
        • Active, not recruiting
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      • Quimper, France, 29107
        • Active, not recruiting
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      • Rennes, France, 35042
        • Withdrawn
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      • Saint-Cloud, France, 92210
        • Withdrawn
        • Research Site
      • Saint-Herblain, France, 44805
        • Withdrawn
        • Research Site
      • Saint-Priest-en-Jarez, France, 42270
        • Active, not recruiting
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      • Suresnes, France, 92151
        • Active, not recruiting
        • Research Site
      • Toulouse, France, 31059
        • Active, not recruiting
        • Research Site
      • Tours, France, 37044
        • Active, not recruiting
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      • Villejuif, France, 94805
        • Active, not recruiting
        • Research Site
      • Batumi, Georgia, 6400
        • Active, not recruiting
        • Research Site
      • Tbilisi, Georgia, 0179
        • Active, not recruiting
        • Research Site
      • Tbilisi, Georgia, 112
        • Active, not recruiting
        • Research Site
      • Tbilisi, Georgia, 160
        • Withdrawn
        • Research Site
      • Tbilisi, Georgia, 186
        • Withdrawn
        • Research Site
      • Aachen, Germany, 52074
        • Recruiting
        • Research Site
      • Augsburg, Germany, 86150
        • Recruiting
        • Research Site
      • Bayreuth, Germany, 95445
        • Withdrawn
        • Research Site
      • Berlin, Germany, 10317
        • Recruiting
        • Research Site
      • Berlin, Germany, 12623
        • Recruiting
        • Research Site
      • Bonn, Germany, 53111
        • Recruiting
        • Research Site
      • Deggendorf, Germany, 94469
        • Withdrawn
        • Research Site
      • Dessau, Germany, 6847
        • Recruiting
        • Research Site
      • Dresden, Germany, 01307
        • Recruiting
        • Research Site
      • Düsseldorf, Germany, 40225
        • Recruiting
        • Research Site
      • Düsseldorf, Germany, 40235
        • Recruiting
        • Research Site
      • Eggenfelden, Germany, 84307
        • Recruiting
        • Research Site
      • Esslingen am Neckar, Germany, 73730
        • Recruiting
        • Research Site
      • Georgsmarienhütte, Germany, 49124
        • Recruiting
        • Research Site
      • Gütersloh, Germany, 33332
        • Recruiting
        • Research Site
      • Hamburg, Germany, 20259
        • Recruiting
        • Research Site
      • Hamburg, Germany, 21073
        • Recruiting
        • Research Site
      • Heidelberg, Germany, 69120
        • Recruiting
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      • Kiel, Germany, 24105
        • Withdrawn
        • Research Site
      • Landshut, Germany, 84036
        • Recruiting
        • Research Site
      • Lübeck, Germany, 23562
        • Withdrawn
        • Research Site
      • Mainz, Germany, 55131
        • Withdrawn
        • Research Site
      • Memmingen, Germany, 87700
        • Recruiting
        • Research Site
      • München, Germany, 80637
        • Recruiting
        • Research Site
      • Ravensburg, Germany, 88212
        • Recruiting
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      • Rüsselsheim am Main, Germany, 65428
        • Recruiting
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      • Stralsund, Germany, 18439
        • Recruiting
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      • Torgau, Germany, 4860
        • Recruiting
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      • Trier, Germany, 54290
        • Recruiting
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      • Ulm, Germany, 89075
        • Withdrawn
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      • Velbert, Germany, 42551
        • Withdrawn
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      • Wiesbaden, Germany, 65199
        • Recruiting
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      • Wiesbaden, Germany, 65189
        • Withdrawn
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      • Worms, Germany, 67550
        • Recruiting
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      • Wuppertal, Germany, 42283
        • Recruiting
        • Research Site
      • Athens, Greece, 11528
        • Active, not recruiting
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      • Athens, Greece, 15123
        • Active, not recruiting
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      • Athens, Greece, 18537
        • Active, not recruiting
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      • Chaïdári, Greece, 124 62
        • Active, not recruiting
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      • Heraklion, Greece, 71110
        • Active, not recruiting
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      • Ioannina, Greece, 45500
        • Active, not recruiting
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      • Rio, Greece, 265 04
        • Active, not recruiting
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      • Thessaloniki, Greece, 54645
        • Active, not recruiting
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      • Thessaloniki, Greece, 546 39
        • Active, not recruiting
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      • Thessaloniki, Greece, 54631
        • Active, not recruiting
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      • Thessaloniki, Greece, 57001
        • Active, not recruiting
        • Research Site
      • Thessaloniki, Greece, 54645
        • Terminated
        • Research Site
      • Budapest, Hungary, 1106
        • Withdrawn
        • Research Site
      • Budapest, Hungary, 1083
        • Active, not recruiting
        • Research Site
      • Budapest, Hungary, 1122
        • Active, not recruiting
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      • Budapest, Hungary, 1115
        • Active, not recruiting
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      • Debrecen, Hungary, 4032
        • Active, not recruiting
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      • Gyula, Hungary, 5700
        • Active, not recruiting
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      • Győr, Hungary, 9024
        • Active, not recruiting
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      • Kaposvár, Hungary, 7400
        • Active, not recruiting
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      • Miskolc, Hungary, 3526
        • Active, not recruiting
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      • Nyíregyháza, Hungary, 4400
        • Active, not recruiting
        • Research Site
      • Szekszárd, Hungary, 7100
        • Active, not recruiting
        • Research Site
      • Szolnok, Hungary, 5000
        • Withdrawn
        • Research Site
      • Bangalore, India, 560076
        • Withdrawn
        • Research Site
      • Bangalore, India, 560027
        • Terminated
        • Research Site
      • Belagavi, India, 590010
        • Withdrawn
        • Research Site
      • Bhubaneswar, India, 751019
        • Withdrawn
        • Research Site
      • Hubli, India, 580029
        • Active, not recruiting
        • Research Site
      • Hyderabad, India, 500082
        • Withdrawn
        • Research Site
      • Jaipur, India, 302017
        • Withdrawn
        • Research Site
      • Kolkata, India, 700020
        • Active, not recruiting
        • Research Site
      • Mumbai, India, 400 012
        • Active, not recruiting
        • Research Site
      • Nagpur, India, 440026
        • Withdrawn
        • Research Site
      • Nashik, India, 422005
        • Active, not recruiting
        • Research Site
      • New Delhi, India, 110076
        • Withdrawn
        • Research Site
      • New Delhi, India, 110 085
        • Active, not recruiting
        • Research Site
      • New Delhi, India, 110005
        • Withdrawn
        • Research Site
      • Pune, India, 411004
        • Withdrawn
        • Research Site
      • Thane, India, 401107
        • Withdrawn
        • Research Site
      • Visakhapatnam, India, 530040
        • Active, not recruiting
        • Research Site
      • West Bengal, India, 700 156
        • Terminated
        • Research Site
      • Afula, Israel, 1834111
        • Active, not recruiting
        • Research Site
      • Ashdod, Israel, 7747629
        • Recruiting
        • Research Site
      • Haifa, Israel, 31096
        • Active, not recruiting
        • Research Site
      • Jerusalem, Israel, 9103102
        • Terminated
        • Research Site
      • Jerusalem, Israel, 00000
        • Active, not recruiting
        • Research Site
      • Kfar Saba, Israel, 4428164
        • Active, not recruiting
        • Research Site
      • Nahariya, Israel, 22100
        • Active, not recruiting
        • Research Site
      • Ramat Gan, Israel, 52621
        • Active, not recruiting
        • Research Site
      • Rehovot, Israel, 7661041
        • Active, not recruiting
        • Research Site
      • Tel Aviv, Israel, 69710
        • Withdrawn
        • Research Site
      • Bari, Italy, 70124
        • Active, not recruiting
        • Research Site
      • Catania, Italy, 95126
        • Active, not recruiting
        • Research Site
      • Catanzaro, Italy, 88100
        • Active, not recruiting
        • Research Site
      • Florence, Italy, 50134
        • Active, not recruiting
        • Research Site
      • Genova, Italy, 16132
        • Active, not recruiting
        • Research Site
      • Grosseto, Italy, 58100
        • Active, not recruiting
        • Research Site
      • Milan, Italy, 20141
        • Active, not recruiting
        • Research Site
      • Milan, Italy, 20132
        • Active, not recruiting
        • Research Site
      • Modena, Italy, 41125
        • Active, not recruiting
        • Research Site
      • Naples, Italy, 80131
        • Active, not recruiting
        • Research Site
      • Naples, Italy, 80131
        • Withdrawn
        • Research Site
      • Pisa, Italy, 56126
        • Active, not recruiting
        • Research Site
      • Reggio Emilia, Italy, 42122
        • Active, not recruiting
        • Research Site
      • Roma, Italy, 00168
        • Active, not recruiting
        • Research Site
      • Rozzano, Italy, 20089
        • Active, not recruiting
        • Research Site
      • Turin, Italy, 10128
        • Active, not recruiting
        • Research Site
      • Chiba, Japan, 260-8717
        • Active, not recruiting
        • Research Site
      • Chūōku, Japan, 104-8560
        • Active, not recruiting
        • Research Site
      • Fukuoka, Japan, 811-1395
        • Active, not recruiting
        • Research Site
      • Fukushima, Japan, 960-1295
        • Active, not recruiting
        • Research Site
      • Hidaka-shi, Japan, 350-1298
        • Active, not recruiting
        • Research Site
      • Hirakata-shi, Japan, 573-1191
        • Active, not recruiting
        • Research Site
      • Hiroshima, Japan, 730-0011
        • Active, not recruiting
        • Research Site
      • Isehara-shi, Japan, 259-1193
        • Active, not recruiting
        • Research Site
      • Kagoshima, Japan, 892-0833
        • Active, not recruiting
        • Research Site
      • Kashiwa, Japan, 227-8577
        • Active, not recruiting
        • Research Site
      • Kitaadachi-gun, Japan, 362-0806
        • Active, not recruiting
        • Research Site
      • Kumamoto, Japan, 860-8556
        • Active, not recruiting
        • Research Site
      • Kurume-shi, Japan, 830-0013
        • Active, not recruiting
        • Research Site
      • Kyoto, Japan, 606-8507
        • Active, not recruiting
        • Research Site
      • Kōtoku, Japan, 135-8550
        • Active, not recruiting
        • Research Site
      • Matsuyama, Japan, 791-0280
        • Active, not recruiting
        • Research Site
      • Nagoya, Japan, 464-8681
        • Active, not recruiting
        • Research Site
      • Nagoya, Japan, 466-8560
        • Active, not recruiting
        • Research Site
      • Nagoya, Japan, 467-0001
        • Active, not recruiting
        • Research Site
      • Niigata, Japan, 951-8566
        • Active, not recruiting
        • Research Site
      • Osaka, Japan, 533-0024
        • Active, not recruiting
        • Research Site
      • Osaka, Japan, 541-8567
        • Active, not recruiting
        • Research Site
      • Osaka, Japan, 540-0006
        • Active, not recruiting
        • Research Site
      • Ota-shi, Japan, 373-8550
        • Active, not recruiting
        • Research Site
      • Sagamihara-shi, Japan, 252-0375
        • Active, not recruiting
        • Research Site
      • Sapporo, Japan, 060-8648
        • Active, not recruiting
        • Research Site
      • Sendai, Japan, 980-8574
        • Active, not recruiting
        • Research Site
      • Shinagawa-ku, Japan, 142-8666
        • Active, not recruiting
        • Research Site
      • Suita-shi, Japan, 565-0871
        • Active, not recruiting
        • Research Site
      • Sunto-gun, Japan, 411-8777
        • Active, not recruiting
        • Research Site
      • Takasaki-shi, Japan, 370-0829
        • Active, not recruiting
        • Research Site
      • Tsu, Japan, 514-8507
        • Active, not recruiting
        • Research Site
      • Yokohama, Japan, 241-8515
        • Active, not recruiting
        • Research Site
      • Ōita, Japan, 870-8511
        • Active, not recruiting
        • Research Site
      • George Town, Malaysia, 10450
        • Active, not recruiting
        • Research Site
      • George Town, Malaysia, 10350
        • Active, not recruiting
        • Research Site
      • Johor Bahru, Malaysia, 81100
        • Active, not recruiting
        • Research Site
      • Kota Bharu, Malaysia, 16150
        • Terminated
        • Research Site
      • Kuala Lumpur, Malaysia, 50300
        • Active, not recruiting
        • Research Site
      • Kuala Lumpur, Malaysia, 50450
        • Active, not recruiting
        • Research Site
      • Kuala Lumpur, Malaysia, 50603
        • Active, not recruiting
        • Research Site
      • Kuching, Malaysia, 93586
        • Active, not recruiting
        • Research Site
      • Malacca, Malaysia, 75000
        • Active, not recruiting
        • Research Site
      • Sabak Bernam, Malaysia, 88996
        • Active, not recruiting
        • Research Site
      • Aguascalientes, Mexico, 20230
        • Active, not recruiting
        • Research Site
      • Alc. Cuauhtémoc, Mexico, 06100
        • Active, not recruiting
        • Research Site
      • Colonia Lindavista, Mexico, 7300
        • Withdrawn
        • Research Site
      • Mexico City, Mexico, 03310
        • Active, not recruiting
        • Research Site
      • Monterrey, Mexico, 64460
        • Withdrawn
        • Research Site
      • Monterrey, Mexico, 64570
        • Withdrawn
        • Research Site
      • Monterrey, Mexico, 64460
        • Active, not recruiting
        • Research Site
      • Mérida, Mexico, 97300
        • Active, not recruiting
        • Research Site
      • México, Mexico, 14080
        • Withdrawn
        • Research Site
      • México, Mexico, 14080
        • Active, not recruiting
        • Research Site
      • México, Mexico, 6700
        • Active, not recruiting
        • Research Site
      • San Luis Potosí City, Mexico, 78250
        • Withdrawn
        • Research Site
      • Toluca, Mexico, 50180
        • Active, not recruiting
        • Research Site
      • Veracruz, Mexico, 91910
        • Active, not recruiting
        • Research Site
      • Veracruz, Mexico, 91900
        • Active, not recruiting
        • Research Site
      • Dirksland, Netherlands, 3247 BW
        • Active, not recruiting
        • Research Site
      • Geleen, Netherlands, 6162 BG
        • Active, not recruiting
        • Research Site
      • Groningen, Netherlands, 9728 NT
        • Withdrawn
        • Research Site
      • Hoofddorp, Netherlands, 2134 TM
        • Withdrawn
        • Research Site
      • Rotterdam, Netherlands, 3079 DZ
        • Withdrawn
        • Research Site
      • Rotterdam, Netherlands, 3083 AN
        • Active, not recruiting
        • Research Site
      • Arequipa, Peru, AREQUIPA01
        • Active, not recruiting
        • Research Site
      • Arequipa, Peru, 04001
        • Withdrawn
        • Research Site
      • Arequipa, Peru, 4001
        • Active, not recruiting
        • Research Site
      • Callao, Peru, 7021
        • Withdrawn
        • Research Site
      • La Libertad, Peru, 13013
        • Withdrawn
        • Research Site
      • Lima, Peru, Lima 32
        • Terminated
        • Research Site
      • Lima, Peru, 0051
        • Withdrawn
        • Research Site
      • Lima, Peru, Lima 34
        • Withdrawn
        • Research Site
      • Lima, Peru, 15076
        • Active, not recruiting
        • Research Site
      • Trujillo, Peru
        • Active, not recruiting
        • Research Site
      • Bacolod, Philippines, 6100
        • Active, not recruiting
        • Research Site
      • Cebu, Philippines, 6000
        • Active, not recruiting
        • Research Site
      • Iloilo City, Philippines, 5000
        • Withdrawn
        • Research Site
      • Manila, Philippines, 1000
        • Withdrawn
        • Research Site
      • Quezon City, Philippines, 1112
        • Active, not recruiting
        • Research Site
      • Quezon City, Philippines, 0870
        • Withdrawn
        • Research Site
      • Quezon City, Philippines, 1101
        • Terminated
        • Research Site
      • Bialystok, Poland, 15-027
        • Active, not recruiting
        • Research Site
      • Grudziądz, Poland, 86-300
        • Active, not recruiting
        • Research Site
      • Koszalin, Poland, 75-581
        • Active, not recruiting
        • Research Site
      • Lodz, Poland, 90-302
        • Active, not recruiting
        • Research Site
      • Lublin, Poland, 20-718
        • Active, not recruiting
        • Research Site
      • Opole, Poland, 45-061
        • Active, not recruiting
        • Research Site
      • Poznan, Poland, 61-485
        • Active, not recruiting
        • Research Site
      • Racibórz, Poland, 47-400
        • Active, not recruiting
        • Research Site
      • Rzeszów, Poland, 35-021
        • Active, not recruiting
        • Research Site
      • Warsaw, Poland, 02-781
        • Active, not recruiting
        • Research Site
      • Wieliszew, Poland, 05-135
        • Active, not recruiting
        • Research Site
      • Amadora, Portugal, 2720-276
        • Active, not recruiting
        • Research Site
      • Braga, Portugal, 4710-243
        • Active, not recruiting
        • Research Site
      • Guimarães, Portugal, 4835-044
        • Active, not recruiting
        • Research Site
      • Lisbon, Portugal, 1649-035
        • Active, not recruiting
        • Research Site
      • Lisbon, Portugal, 1998-018
        • Active, not recruiting
        • Research Site
      • Matosinhos Municipality, Portugal, 4454-509
        • Active, not recruiting
        • Research Site
      • Porto, Portugal, 4100-180
        • Active, not recruiting
        • Research Site
      • Porto, Portugal, 4200-072
        • Active, not recruiting
        • Research Site
      • Porto, Portugal, 4200-319
        • Active, not recruiting
        • Research Site
      • Vila Nova de Gaia, Portugal, 4434-502
        • Active, not recruiting
        • Research Site
      • Baia Mare, Romania, 430031
        • Withdrawn
        • Research Site
      • Brasov, Romania, 500283
        • Active, not recruiting
        • Research Site
      • Cluj-Napoca, Romania, 400641
        • Active, not recruiting
        • Research Site
      • Cluj-Napoca, Romania, 400015
        • Terminated
        • Research Site
      • Constanța, Romania, 900591
        • Terminated
        • Research Site
      • Craiova, Romania, 200094
        • Active, not recruiting
        • Research Site
      • Craiova, Romania, 200347
        • Active, not recruiting
        • Research Site
      • Craiova, Romania, 200385
        • Active, not recruiting
        • Research Site
      • Floreşti, Romania, 407280
        • Active, not recruiting
        • Research Site
      • Iași, Romania, 700106
        • Active, not recruiting
        • Research Site
      • Oradea, Romania, 410167
        • Withdrawn
        • Research Site
      • Piteşti, Romania, 110283
        • Active, not recruiting
        • Research Site
      • Sibiu, Romania, 550245
        • Active, not recruiting
        • Research Site
      • Timișoara, Romania, 300239
        • Active, not recruiting
        • Research Site
      • Timișoara, Romania, 300166
        • Withdrawn
        • Research Site
      • Belgrade, Serbia, 11000
        • Active, not recruiting
        • Research Site
      • Belgrade, Serbia, 11080
        • Active, not recruiting
        • Research Site
      • Belgrade, Serbia, 11010
        • Active, not recruiting
        • Research Site
      • Kamenitz, Serbia, 21204
        • Active, not recruiting
        • Research Site
      • Kragujevac, Serbia, 34000
        • Active, not recruiting
        • Research Site
      • Niš, Serbia, 18000
        • Active, not recruiting
        • Research Site
      • Valjevo, Serbia, 14000
        • Active, not recruiting
        • Research Site
      • Zrenjanin, Serbia, 23000
        • Active, not recruiting
        • Research Site
      • Singapore, Singapore, 329563
        • Active, not recruiting
        • Research Site
      • Singapore, Singapore, 119074
        • Active, not recruiting
        • Research Site
      • Singapore, Singapore, 308433
        • Active, not recruiting
        • Research Site
      • Singapore, Singapore, 228510
        • Active, not recruiting
        • Research Site
      • Bloemfontein, South Africa, 9301
        • Withdrawn
        • Research Site
      • Bloemfontein, South Africa, 9301
        • Active, not recruiting
        • Research Site
      • George, South Africa, 6529
        • Active, not recruiting
        • Research Site
      • George, South Africa, 6529
        • Withdrawn
        • Research Site
      • Johannesburg, South Africa, 2193
        • Recruiting
        • Research Site
      • Johannesburg, South Africa, 2196
        • Terminated
        • Research Site
      • Pietermaritzburg, South Africa, 3201
        • Withdrawn
        • Research Site
      • Pretoria, South Africa, 0084
        • Withdrawn
        • Research Site
      • Pretoria, South Africa, 31
        • Active, not recruiting
        • Research Site
      • Soweto, South Africa, 2193
        • Active, not recruiting
        • Research Site
      • eManzimtoti, South Africa, 4126
        • Terminated
        • Research Site
      • Busan, South Korea, 48108
        • Active, not recruiting
        • Research Site
      • Daegu, South Korea, 42601
        • Active, not recruiting
        • Research Site
      • Donggu, South Korea, 44033
        • Withdrawn
        • Research Site
      • Goyang-si, South Korea, 10408
        • Active, not recruiting
        • Research Site
      • Jeonnam, South Korea, 58128
        • Active, not recruiting
        • Research Site
      • Seongbuk-Gu, South Korea, 2841
        • Withdrawn
        • Research Site
      • Seoul, South Korea, 03080
        • Active, not recruiting
        • Research Site
      • Seoul, South Korea, 03722
        • Active, not recruiting
        • Research Site
      • Seoul, South Korea, 06273
        • Active, not recruiting
        • Research Site
      • Seoul, South Korea, 06351
        • Active, not recruiting
        • Research Site
      • Seoul, South Korea, 06591
        • Active, not recruiting
        • Research Site
      • Seoul, South Korea, 158-710
        • Active, not recruiting
        • Research Site
      • Seoul, South Korea, 08308
        • Terminated
        • Research Site
      • A Coruña, Spain, 15009
        • Active, not recruiting
        • Research Site
      • A Coruña, Spain, 15006
        • Active, not recruiting
        • Research Site
      • Albacete, Spain, 02006
        • Active, not recruiting
        • Research Site
      • Alcoy, Spain, 3804
        • Active, not recruiting
        • Research Site
      • Alicante, Spain, 3015
        • Active, not recruiting
        • Research Site
      • Alzira, Spain, 46600
        • Active, not recruiting
        • Research Site
      • Badajoz, Spain, 06080
        • Active, not recruiting
        • Research Site
      • Badalona, Spain, 08916
        • Active, not recruiting
        • Research Site
      • Badalona, Spain, 08003
        • Recruiting
        • Research Site
      • Barakaldo, Spain, 48903
        • Active, not recruiting
        • Research Site
      • Barcelona, Spain, 8035
        • Recruiting
        • Research Site
      • Barcelona, Spain, 08036
        • Active, not recruiting
        • Research Site
      • Barcelona, Spain, 08028
        • Active, not recruiting
        • Research Site
      • Cáceres, Spain, 10003
        • Active, not recruiting
        • Research Site
      • Elche(Alicante), Spain, 03202
        • Active, not recruiting
        • Research Site
      • Galdakao, Spain, 48960
        • Active, not recruiting
        • Research Site
      • Girona, Spain, 17007
        • Active, not recruiting
        • Research Site
      • Granada, Spain, 18014
        • Active, not recruiting
        • Research Site
      • Granada, Spain, 18007
        • Active, not recruiting
        • Research Site
      • Jerez de La Frontera (Cádiz), Spain, 11407
        • Active, not recruiting
        • Research Site
      • L'Hospitalet de Llobregat, Spain, 08908
        • Active, not recruiting
        • Research Site
      • Leganés, Spain, 28911
        • Active, not recruiting
        • Research Site
      • Lleida, Spain, 25198
        • Active, not recruiting
        • Research Site
      • Madrid, Spain, 28040
        • Recruiting
        • Research Site
      • Madrid, Spain, 28040
        • Active, not recruiting
        • Research Site
      • Madrid, Spain, 28033
        • Active, not recruiting
        • Research Site
      • Madrid, Spain, 28050
        • Active, not recruiting
        • Research Site
      • Majadahonda, Spain, 28222
        • Active, not recruiting
        • Research Site
      • Manresa, Spain, 8242
        • Active, not recruiting
        • Research Site
      • Murcia, Spain, 30008
        • Active, not recruiting
        • Research Site
      • Oviedo, Spain, 33011
        • Active, not recruiting
        • Research Site
      • Parla, Spain, 28981
        • Active, not recruiting
        • Research Site
      • Port de Sagunt, Spain, 46520
        • Active, not recruiting
        • Research Site
      • Reus, Spain, 43204
        • Active, not recruiting
        • Research Site
      • Salamanca, Spain, 37007
        • Active, not recruiting
        • Research Site
      • San Sebastián, Spain, 20014
        • Active, not recruiting
        • Research Site
      • Sant Joan d'Alacant, Spain, 03550
        • Withdrawn
        • Research Site
      • Santander, Spain, 39008
        • Active, not recruiting
        • Research Site
      • Seville, Spain, 41009
        • Active, not recruiting
        • Research Site
      • Seville, Spain, 41013
        • Active, not recruiting
        • Research Site
      • Teruel, Spain, 44001
        • Terminated
        • Research Site
      • Toledo, Spain, 45007
        • Withdrawn
        • Research Site
      • Valencia, Spain, 46009
        • Active, not recruiting
        • Research Site
      • Valencia, Spain, 46017
        • Active, not recruiting
        • Research Site
      • Valencia, Spain, 46015
        • Active, not recruiting
        • Research Site
      • Hsinchu, Taiwan, 300
        • Active, not recruiting
        • Research Site
      • Kaohsiung City, Taiwan, 82445
        • Active, not recruiting
        • Research Site
      • Taichung, Taiwan, 40447
        • Withdrawn
        • Research Site
      • Tainan, Taiwan, 710
        • Active, not recruiting
        • Research Site
      • Tainan, Taiwan, 70403
        • Active, not recruiting
        • Research Site
      • Taipei, Taiwan, 10002
        • Active, not recruiting
        • Research Site
      • Taipei, Taiwan, 11259
        • Active, not recruiting
        • Research Site
      • Taipei, Taiwan, 110
        • Active, not recruiting
        • Research Site
      • Bangkok, Thailand, 10400
        • Active, not recruiting
        • Research Site
      • Bangkok, Thailand, 10700
        • Active, not recruiting
        • Research Site
      • Khon Kaen, Thailand, 40002
        • Active, not recruiting
        • Research Site
      • Phisanulok, Thailand, 65000
        • Active, not recruiting
        • Research Site
      • Phitsanulok, Thailand, 65000
        • Active, not recruiting
        • Research Site
      • Rachathewi, Thailand, 10400
        • Active, not recruiting
        • Research Site
      • Songkhla, Thailand, 90110
        • Active, not recruiting
        • Research Site
      • Ankara, Turkey (Türkiye), 06100
        • Active, not recruiting
        • Research Site
      • Ankara, Turkey (Türkiye), 06200
        • Active, not recruiting
        • Research Site
      • Ankara, Turkey (Türkiye), 06520
        • Active, not recruiting
        • Research Site
      • Ankara, Turkey (Türkiye), 06620
        • Withdrawn
        • Research Site
      • Ankara, Turkey (Türkiye), 6800
        • Withdrawn
        • Research Site
      • Aydin, Turkey (Türkiye), 9010
        • Active, not recruiting
        • Research Site
      • Bursa, Turkey (Türkiye), 16059
        • Withdrawn
        • Research Site
      • Dinar, Turkey (Türkiye), 03400
        • Active, not recruiting
        • Research Site
      • Istanbul, Turkey (Türkiye), 34010
        • Withdrawn
        • Research Site
      • Istanbul, Turkey (Türkiye), 34218
        • Withdrawn
        • Research Site
      • Istanbul, Turkey (Türkiye), 34899
        • Active, not recruiting
        • Research Site
      • Izmir, Turkey (Türkiye), 35120
        • Withdrawn
        • Research Site
      • Izmir, Turkey (Türkiye), 35150
        • Active, not recruiting
        • Research Site
      • Izmir, Turkey (Türkiye), 35530
        • Active, not recruiting
        • Research Site
      • Izmir, Turkey (Türkiye), 35575
        • Active, not recruiting
        • Research Site
      • Samsun, Turkey (Türkiye), 55200
        • Active, not recruiting
        • Research Site
      • Brighton, United Kingdom, BN2 5BE
        • Active, not recruiting
        • Research Site
      • Burton-on-Trent, United Kingdom, DE13 0RB
        • Active, not recruiting
        • Research Site
      • Cambridge, United Kingdom, CB2 0QQ
        • Active, not recruiting
        • Research Site
      • Derby, United Kingdom, DE22 3NE
        • Active, not recruiting
        • Research Site
      • Edinburgh, United Kingdom, EH4 2XU
        • Active, not recruiting
        • Research Site
      • Guildford, United Kingdom
        • Withdrawn
        • Research Site
      • Ipswich, United Kingdom, IP4 5PD
        • Active, not recruiting
        • Research Site
      • Keighley, United Kingdom, BD20 6TD
        • Withdrawn
        • Research Site
      • London, United Kingdom, SW3 6JJ
        • Active, not recruiting
        • Research Site
      • London, United Kingdom, SE1 9RT
        • Terminated
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Active, not recruiting
        • Research Site
      • Oxford, United Kingdom, OX3 7LJ
        • Active, not recruiting
        • Research Site
      • Peterborough, United Kingdom, PE3 9GZ
        • Withdrawn
        • Research Site
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • Withdrawn
        • Research Site
      • Sutton, United Kingdom, SM2 5PT
        • Active, not recruiting
        • Research Site
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Active, not recruiting
        • Research Site
      • Dothan, Alabama, United States, 36303
        • Active, not recruiting
        • Research Site
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Active, not recruiting
        • Research Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Active, not recruiting
        • Research Site
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Active, not recruiting
        • Research Site
    • California
      • Anaheim, California, United States, 92801
        • Active, not recruiting
        • Research Site
      • Beverly Hills, California, United States, 90211
        • Active, not recruiting
        • Research Site
      • Concord, California, United States, 94520
        • Active, not recruiting
        • Research Site
      • Corona, California, United States, 92882
        • Active, not recruiting
        • Research Site
      • Fountain Valley, California, United States, 92708
        • Active, not recruiting
        • Research Site
      • Greenbrae, California, United States, 94904
        • Active, not recruiting
        • Research Site
      • Los Alamitos, California, United States, 90720
        • Active, not recruiting
        • Research Site
      • Palo Alto, California, United States, 94304
        • Active, not recruiting
        • Research Site
      • San Diego, California, United States, 92123
        • Active, not recruiting
        • Research Site
      • San Diego, California, United States, 92121
        • Active, not recruiting
        • Research Site
      • Whittier, California, United States, 90603
        • Active, not recruiting
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Withdrawn
        • Research Site
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Active, not recruiting
        • Research Site
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Active, not recruiting
        • Research Site
      • Gainesville, Florida, United States, 32603
        • Active, not recruiting
        • Research Site
      • Miami Beach, Florida, United States, 33140
        • Active, not recruiting
        • Research Site
      • Orlando, Florida, United States, 32806
        • Active, not recruiting
        • Research Site
      • Plantation, Florida, United States, 33324
        • Active, not recruiting
        • Research Site
      • Port Saint Lucie, Florida, United States, 34952
        • Active, not recruiting
        • Research Site
      • Saint Augustine, Florida, United States, 32086
        • Active, not recruiting
        • Research Site
      • St. Petersburg, Florida, United States, 33705
        • Active, not recruiting
        • Research Site
      • St. Petersburg, Florida, United States, 33709
        • Active, not recruiting
        • Research Site
      • Tallahassee, Florida, United States, 32308
        • Active, not recruiting
        • Research Site
      • West Palm Beach, Florida, United States, 33401
        • Active, not recruiting
        • Research Site
      • Winter Haven, Florida, United States, 33880
        • Active, not recruiting
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30310
        • Active, not recruiting
        • Research Site
      • Atlanta, Georgia, United States, 30318
        • Active, not recruiting
        • Research Site
      • Columbus, Georgia, United States, 31904
        • Active, not recruiting
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Withdrawn
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Active, not recruiting
        • Research Site
      • Chicago, Illinois, United States, 60608
        • Withdrawn
        • Research Site
      • Decatur, Illinois, United States, 62526
        • Active, not recruiting
        • Research Site
      • Elmhurst, Illinois, United States, 60126
        • Active, not recruiting
        • Research Site
      • Hinsdale, Illinois, United States, 60521
        • Active, not recruiting
        • Research Site
      • Park Ridge, Illinois, United States, 60068
        • Active, not recruiting
        • Research Site
      • Park Ridge, Illinois, United States, 60068
        • Terminated
        • Research Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Active, not recruiting
        • Research Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • Research Site
      • Iowa City, Iowa, United States, 52242
        • Active, not recruiting
        • Research Site
    • Kentucky
      • Fort Mitchell, Kentucky, United States, 41017
        • Active, not recruiting
        • Research Site
      • Lexington, Kentucky, United States, 40536
        • Active, not recruiting
        • Research Site
      • Louisville, Kentucky, United States, 40202
        • Active, not recruiting
        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Active, not recruiting
        • Research Site
    • Maine
      • Brewer, Maine, United States, 04412
        • Withdrawn
        • Research Site
      • Scarborough, Maine, United States, 04074
        • Withdrawn
        • Research Site
    • Maryland
      • Frederick, Maryland, United States, 21702
        • Active, not recruiting
        • Research Site
      • Glenn Dale, Maryland, United States, 20769
        • Active, not recruiting
        • Research Site
      • Silver Spring, Maryland, United States, 20910
        • Active, not recruiting
        • Research Site
      • Towson, Maryland, United States, 21204
        • Active, not recruiting
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Withdrawn
        • Research Site
      • Hyannis, Massachusetts, United States, 02601
        • Active, not recruiting
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Active, not recruiting
        • Research Site
      • Detroit, Michigan, United States, 48202
        • Active, not recruiting
        • Research Site
      • East Lansing, Michigan, United States, 48824
        • Active, not recruiting
        • Research Site
      • Lansing, Michigan, United States, 48910
        • Active, not recruiting
        • Research Site
      • Royal Oak, Michigan, United States, 48073
        • Active, not recruiting
        • Research Site
    • Missouri
      • Independence, Missouri, United States, 64057
        • Active, not recruiting
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Active, not recruiting
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Terminated
        • Research Site
    • New Hampshire
      • Laconia, New Hampshire, United States, 03246
        • Active, not recruiting
        • Research Site
    • New Jersey
      • Belleville, New Jersey, United States, 07109
        • Active, not recruiting
        • Research Site
    • New Mexico
      • Farmington, New Mexico, United States, 87401
        • Active, not recruiting
        • Research Site
      • Santa Fe, New Mexico, United States, 87505
        • Active, not recruiting
        • Research Site
    • New York
      • East Syracuse, New York, United States, 13057
        • Active, not recruiting
        • Research Site
      • New Hyde Park, New York, United States, 11042
        • Withdrawn
        • Research Site
      • New York, New York, United States, 10011
        • Active, not recruiting
        • Research Site
      • New York, New York, United States, 10029
        • Active, not recruiting
        • Research Site
      • New York, New York, United States, 10019
        • Withdrawn
        • Research Site
      • Stony Brook, New York, United States, 11794
        • Active, not recruiting
        • Research Site
      • The Bronx, New York, United States, 10461
        • Active, not recruiting
        • Research Site
      • White Plains, New York, United States, 10601
        • Active, not recruiting
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Active, not recruiting
        • Research Site
      • Durham, North Carolina, United States, 27710-0001
        • Active, not recruiting
        • Research Site
      • Greensboro, North Carolina, United States, 27403
        • Withdrawn
        • Research Site
      • Raleigh, North Carolina, United States, 27607
        • Active, not recruiting
        • Research Site
      • Rocky Mount, North Carolina, United States, 27804
        • Active, not recruiting
        • Research Site
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Research Site
      • Winston-Salem, North Carolina, United States, 27104
        • Recruiting
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Withdrawn
        • Research Site
      • Cincinnati, Ohio, United States, 45255
        • Active, not recruiting
        • Research Site
      • Cleveland, Ohio, United States, 44195
        • Active, not recruiting
        • Research Site
      • Cleveland, Ohio, United States, 44106
        • Active, not recruiting
        • Research Site
      • Youngstown, Ohio, United States, 44504
        • Withdrawn
        • Research Site
    • Pennsylvania
      • Clairton, Pennsylvania, United States, 15025
        • Active, not recruiting
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19111
        • Active, not recruiting
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19106
        • Active, not recruiting
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Active, not recruiting
        • Research Site
      • Reading, Pennsylvania, United States, 19611
        • Active, not recruiting
        • Research Site
      • State College, Pennsylvania, United States, 16803
        • Terminated
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Active, not recruiting
        • Research Site
    • South Carolina
      • Lancaster, South Carolina, United States, 29720
        • Withdrawn
        • Research Site
      • Spartanburg, South Carolina, United States, 29303
        • Active, not recruiting
        • Research Site
    • South Dakota
      • Aberdeen, South Dakota, United States, 57401
        • Recruiting
        • Research Site
      • Mitchell, South Dakota, United States, 57301
        • Active, not recruiting
        • Research Site
      • Pierre, South Dakota, United States, 57501
        • Recruiting
        • Research Site
      • Sioux Falls, South Dakota, United States, 57105
        • Active, not recruiting
        • Research Site
      • Yankton, South Dakota, United States, 57078
        • Active, not recruiting
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Active, not recruiting
        • Research Site
      • Knoxville, Tennessee, United States, 37920
        • Active, not recruiting
        • Research Site
      • Nashville, Tennessee, United States, 37203
        • Active, not recruiting
        • Research Site
      • Nashville, Tennessee, United States, 37204
        • Active, not recruiting
        • Research Site
    • Texas
      • Austin, Texas, United States, 78731
        • Withdrawn
        • Research Site
      • Dallas, Texas, United States, 75230
        • Active, not recruiting
        • Research Site
      • Denton, Texas, United States, 76201
        • Active, not recruiting
        • Research Site
      • Houston, Texas, United States, 77030
        • Active, not recruiting
        • Research Site
      • Houston, Texas, United States, 77024
        • Active, not recruiting
        • Research Site
      • Irving, Texas, United States, 75063
        • Recruiting
        • Research Site
    • Utah
      • Ogden, Utah, United States, 84405
        • Active, not recruiting
        • Research Site
      • Salt Lake City, Utah, United States, 84106
        • Active, not recruiting
        • Research Site
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Active, not recruiting
        • Research Site
      • Lynchburg, Virginia, United States, 24501
        • Active, not recruiting
        • Research Site
      • Midlothian, Virginia, United States, 23114
        • Active, not recruiting
        • Research Site
      • Reston, Virginia, United States, 20190
        • Active, not recruiting
        • Research Site
      • Richmond, Virginia, United States, 23235
        • Active, not recruiting
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98104
        • Active, not recruiting
        • Research Site
      • Seattle, Washington, United States, 98101
        • Active, not recruiting
        • Research Site
      • Spokane, Washington, United States, 99202
        • Active, not recruiting
        • Research Site
      • Tacoma, Washington, United States, 98405
        • Active, not recruiting
        • Research Site
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Withdrawn
        • Research Site
      • Morgantown, West Virginia, United States, 26505
        • Active, not recruiting
        • Research Site
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • Withdrawn
        • Research Site
      • Madison, Wisconsin, United States, 53792
        • Active, not recruiting
        • Research Site
      • Milwaukee, Wisconsin, United States, 53226
        • Active, not recruiting
        • Research Site
      • Hanoi, Vietnam, 100000
        • Active, not recruiting
        • Research Site
      • Ho Chi Minh City, Vietnam, 700000
        • Active, not recruiting
        • Research Site
      • Ho Chi Minh City, Vietnam, 70000
        • Active, not recruiting
        • Research Site
      • Huế, Vietnam, 530000
        • Withdrawn
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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. Comparator. Administered per local approved label
Anastrozole. Comparator. Administered per local approved label
Letrozole. Comparator. Administered per local approved label
Exemestane. Comparator. Administered per local approved label
Experimental: Arm B: camizestrant
Camizestrant
Camizestrant. Experimental. Administered orally
Other Names:
  • AZD9833

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Invasive breast cancer-free survival (IBCFS)
Time Frame: Up to 10 years

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.
Up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distant relapse-free survival (DRFS)
Time Frame: Up to 10 years
DRFS is defined as time from randomisation until date of first distant recurrence or death from any cause, whichever occurs first.
Up to 10 years
Overall survival (OS)
Time Frame: Up to 10 years
OS is defined as time from randomisation until death from any cause.
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)
Time Frame: Until 28 days after the final dose of study treatment (up to 5 years)
Until 28 days after the final dose of study treatment (up to 5 years)
Absolute and percent change from baseline in Clinical Laboratory Parameters
Time Frame: Until 28 days after the final dose of study treatment (up to 5 years)
Until 28 days after the final dose of study treatment (up to 5 years)
Absolute and percent change from baseline in Vital Sign Parameters
Time Frame: Until 28 days after the final dose of study treatment (up to 5 years)
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)
Time Frame: Until 28 days after the final dose of study treatment (up to 5 years)
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)
Time Frame: Until 28 days after the final dose of study treatment (up to 5 years)
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)
Time Frame: Until 28 days after the final dose of study treatment (up to 5 years)
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)
Time Frame: Until 28 days after the final dose of study treatment (up to 5 years)
Until 28 days after the final dose of study treatment (up to 5 years)
Pharmacokinetics (PK)
Time Frame: Until 6 months from treatment start
• Plasma concentrations of camizestrant pre-dose (Ctrough)( trough concentration)
Until 6 months from treatment start
Invasive disease-free survival (IDFS)
Time Frame: Up to 10 years

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.
Up to 10 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)
Time Frame: Until 28 days after the final dose of study treatment (up to 5 years)
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)
Time Frame: Until 28 days after the final dose of study treatment (up to 5 years)
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)
Time Frame: Until 28 days after the final dose of study treatment (up to 5 years)
Until 28 days after the final dose of study treatment (up to 5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2023

Primary Completion (Estimated)

April 20, 2027

Study Completion (Estimated)

May 29, 2036

Study Registration Dates

First Submitted

February 16, 2023

First Submitted That Met QC Criteria

March 7, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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