An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2) (CAMBRIA-2)

June 18, 2025 updated by: AstraZeneca

CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years.

Study Overview

Detailed Description

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. 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)

5500

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, C1426ANZ
        • Recruiting
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      • Buenos Aires, Argentina, C1417
        • Not yet recruiting
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      • Buenos Aires, Argentina, C1025ABI
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      • Caba, Argentina, C1061
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      • Capital Federal, Argentina, 1118
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      • Ciudad Autonoma de Buenos Aires, Argentina, 1426
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      • Ciudad de Córdoba, Argentina, X5800HHW
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      • Cordoba, Argentina, 5001
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      • La Plata, Argentina, 1900
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      • Rosario, Argentina, 2123
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      • San Juan, Argentina, 5400
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      • San Miguel de Tucuman, Argentina, T4000IAK
        • Not yet recruiting
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      • Viedma, Argentina, R8500ACE
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      • Adelaide, Australia, 5081
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      • Bankstown, Australia, 2200
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      • Bendigo, Australia, 3550
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      • Bowral, Australia, 2576
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      • Brighton, Australia, 3186
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      • Clayton, Australia, 3168
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      • Coffs Harbour, Australia, 2450
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      • Fitzroy, Australia, 3065
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      • Frankston, Australia, 3199
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      • Garran, Australia, 2605
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      • Gateshead, Australia, 2290
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      • Heidelberg, Australia, 3084
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      • Liverpool, Australia, 2170
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      • Melbourne, Australia, 3004
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      • Murdoch, Australia, WA6150
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      • Randwick, Australia, 2031
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      • Shepparton, Australia, 3630
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      • Traralgon, Australia, 3844
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      • Warnnambool, Australia, 3280
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      • Graz, Austria, 8036
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      • Wien, Austria, 1180
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      • Wiener Neustadt, Austria, 2700
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      • Aalst, Belgium, 9300
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      • Gent, Belgium, 9000
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      • Blumenau, Brazil, 89010-340
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      • Brasília, Brazil, 71615-907
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      • Curitiba, Brazil, 80810-050
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      • Fortaleza, Brazil, 60430-230
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      • Goiânia, Brazil, 74000-000
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      • Joao Pessoa, Brazil, 58013-140
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      • Natal, Brazil, 59075-740
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      • Dobrich, Bulgaria, 9300
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      • Sofia, Bulgaria, 1330
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      • Sofia, Bulgaria, 1404
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      • Varna, Bulgaria, 9010
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      • Quebec, Canada, G1S 4L8
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    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
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      • Edmonton, Alberta, Canada, t6G1Z2
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    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
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      • North Vancouver, British Columbia, Canada, V7L 2L7
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    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
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    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
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      • Kingston, Ontario, Canada, K7L 2V7
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      • Sault Ste. Marie, Ontario, Canada, P6A 0A8
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      • Sudbury, Ontario, Canada, P3E 5J1
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      • Thunder Bay, Ontario, Canada, P7B 6V4
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      • Windsor, Ontario, Canada, N8W 2X3
        • Withdrawn
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    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
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      • Montreal, Quebec, Canada, H4A 3J1
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      • Montreal, Quebec, Canada, H2X 3E4
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      • Montreal, Quebec, Canada, H1T 2M4
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    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
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      • Concepcion, Chile, 4070196
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      • La Serena, Chile, 1720430
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      • Vina del Mar, Chile, 2520000
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      • Baoding, China, 071000
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      • Beijing, China, 100191
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      • Bengbu, China, 233004
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      • Binzhou, China, 256606
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      • Cangzhou, China, 061001
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      • Changchun, China, 130021
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      • Changsha, China, 410008
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      • Chengdu, China, 610072
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      • Batumi, Georgia, 6000
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      • Thessaloniki, Greece, 54645
        • Not yet recruiting
        • Research Site
      • Thessaloniki, Greece, 546 39
        • Recruiting
        • Research Site
      • Thessaloniki, Greece, 552 36
        • Recruiting
        • Research Site
      • Thessaloniki, Greece, 56403
        • Recruiting
        • Research Site
      • Budapest, Hungary, 1122
        • Recruiting
        • Research Site
      • Budapest, Hungary, 1082
        • Recruiting
        • Research Site
      • Debrecen, Hungary, 4032
        • Active, not recruiting
        • Research Site
      • Gyula, Hungary, 5700
        • Recruiting
        • Research Site
      • Győr, Hungary, 9024
        • Not yet recruiting
        • Research Site
      • Kaposvár, Hungary, 7400
        • Recruiting
        • Research Site
      • Kecskemét, Hungary, 6000
        • Recruiting
        • Research Site
      • Miskolc, Hungary, 3526
        • Recruiting
        • Research Site
      • Nyíregyháza, Hungary, 4400
        • Recruiting
        • Research Site
      • Salgotarjan, Hungary, 3100
        • Recruiting
        • Research Site
      • Szeged, Hungary, 6725
        • Recruiting
        • Research Site
      • Szekszárd, Hungary, 7100
        • Recruiting
        • Research Site
      • Zalaegerszeg, Hungary, 8900
        • Recruiting
        • Research Site
      • Ansari Nagar, India, 110 029
        • Recruiting
        • Research Site
      • Bangalore, India, 560064
        • Recruiting
        • Research Site
      • Belgavi, India, 590010
        • Not yet recruiting
        • Research Site
      • Dehradun, India, 248016
        • Recruiting
        • Research Site
      • Delhi, India, 110088
        • Recruiting
        • Research Site
      • Dhanvantari Nagar, India, 605006
        • Recruiting
        • Research Site
      • Gurgaon, India, 122001
        • Withdrawn
        • Research Site
      • Hyderabad, India, 500082
        • Withdrawn
        • Research Site
      • JAipur, India, 302022
        • Not yet recruiting
        • Research Site
      • Kanpur, India, 208005
        • Not yet recruiting
        • Research Site
      • Kolkata, India, 700160
        • Recruiting
        • Research Site
      • Kolkata, India, 700099
        • Not yet recruiting
        • Research Site
      • Kozhikode, India, 673 601
        • Not yet recruiting
        • Research Site
      • Mumbai, India, 400012
        • Withdrawn
        • Research Site
      • Mumbai, India, 400612
        • Recruiting
        • Research Site
      • Mysuru, India, 570017
        • Recruiting
        • Research Site
      • Nagpur, India, 440001
        • Recruiting
        • Research Site
      • Nashik, India, 422002
        • Recruiting
        • Research Site
      • Nashik, India, 422 009
        • Recruiting
        • Research Site
      • New Delhi, India, 110 085
        • Recruiting
        • Research Site
      • New Delhi, India, 110075
        • Recruiting
        • Research Site
      • New Delhi, India, 110029
        • Not yet recruiting
        • Research Site
      • Surat, India, 395002
        • Recruiting
        • Research Site
      • Cork, Ireland, T12 DV56
        • Recruiting
        • Research Site
      • Dublin, Ireland, 7
        • Recruiting
        • Research Site
      • Dublin, Ireland, D09V2N0
        • Recruiting
        • Research Site
      • Dublin, Ireland, DO4YN63
        • Recruiting
        • Research Site
      • Dublin, Ireland, 7
        • Active, not recruiting
        • Research Site
      • Galway, Ireland, H91 YR71
        • Recruiting
        • Research Site
      • Waterford, Ireland, X91 ER8E
        • Recruiting
        • Research Site
      • Afula, Israel, 18101
        • Recruiting
        • Research Site
      • Ashdod, Israel, 7747629
        • Not yet recruiting
        • Research Site
      • Beer Sheva, Israel, 84101
        • Recruiting
        • Research Site
      • Haifa, Israel, 31096
        • Recruiting
        • Research Site
      • Jerusalem, Israel, 91120
        • Recruiting
        • Research Site
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Research Site
      • Kfar Saba, Israel, 49281
        • Recruiting
        • Research Site
      • Nahariya, Israel, 22100
        • Recruiting
        • Research Site
      • Ramat Gan, Israel, 5262000
        • Recruiting
        • Research Site
      • Bergamo, Italy, 24127
        • Recruiting
        • Research Site
      • Bologna, Italy, 40138
        • Recruiting
        • Research Site
      • Brindisi, Italy, 72100
        • Recruiting
        • Research Site
      • Firenze, Italy, 50134
        • Recruiting
        • Research Site
      • Genoa, Italy, 16132
        • Recruiting
        • Research Site
      • Meldola, Italy, 47014
        • Recruiting
        • Research Site
      • Milan, Italy, 20141
        • Recruiting
        • Research Site
      • Milano, Italy, 20132
        • Recruiting
        • Research Site
      • Misterbianco, Italy, 95045
        • Recruiting
        • Research Site
      • Modena, Italy, 41124
        • Recruiting
        • Research Site
      • Monza, Italy, 20900
        • Recruiting
        • Research Site
      • Napoli, Italy, 80131
        • Recruiting
        • Research Site
      • Novara, Italy, 28100
        • Recruiting
        • Research Site
      • Padova, Italy, 35128
        • Recruiting
        • Research Site
      • Roma, Italy, 00168
        • Recruiting
        • Research Site
      • Roma, Italy, 00161
        • Recruiting
        • Research Site
      • Rozzano, Italy, 20089
        • Recruiting
        • Research Site
      • Torino, Italy, 10126
        • Recruiting
        • Research Site
      • Trento, Italy, 38100
        • Recruiting
        • Research Site
      • Bunkyo-ku, Japan, 113-8431
        • Not yet recruiting
        • Research Site
      • Chiba-shi, Japan, 260-8717
        • Recruiting
        • Research Site
      • Chuo-ku, Japan, 104-8560
        • Recruiting
        • Research Site
      • Fukuoka-shi, Japan, 811-1395
        • Recruiting
        • Research Site
      • Fukushima-shi, Japan, 960-1295
        • Recruiting
        • Research Site
      • Hirakata-shi, Japan, 573-1191
        • Recruiting
        • Research Site
      • Hiroshima-shi, Japan, 730-8518
        • Recruiting
        • Research Site
      • Iruma-Gun, Japan, 350-0495
        • Recruiting
        • Research Site
      • Isehara-shi, Japan, 259-1193
        • Recruiting
        • Research Site
      • Kagoshima-shi, Japan, 892-0833
        • Recruiting
        • Research Site
      • Kashiwa, Japan, 277-8577
        • Recruiting
        • Research Site
      • Koto-ku, Japan, 135-8550
        • Recruiting
        • Research Site
      • Kumamoto-shi, Japan, 860-8556
        • Recruiting
        • Research Site
      • Kurume-shi, Japan, 830-0013
        • Recruiting
        • Research Site
      • Kyoto-shi, Japan, 606-8507
        • Recruiting
        • Research Site
      • Matsuyama-shi, Japan, 791-0280
        • Recruiting
        • Research Site
      • Nagoya-shi, Japan, 464-8681
        • Recruiting
        • Research Site
      • Nagoya-shi, Japan, 467-0001
        • Recruiting
        • Research Site
      • Nagoya-shi, Japan, 466-8550
        • Recruiting
        • Research Site
      • Niigata-shi, Japan, 951-8566
        • Recruiting
        • Research Site
      • Osaka-shi, Japan, 541-8567
        • Recruiting
        • Research Site
      • Ota-shi, Japan, 373-8550
        • Recruiting
        • Research Site
      • Sapporo-shi, Japan, 060-8638
        • Recruiting
        • Research Site
      • Sapporo-shi, Japan, 003-0804
        • Recruiting
        • Research Site
      • Sendai-shi, Japan
        • Recruiting
        • Research Site
      • Shinagawa-ku, Japan, 142-8666
        • Recruiting
        • Research Site
      • Suita-shi, Japan, 565-0871
        • Recruiting
        • Research Site
      • Sunto-gun, Japan, 411-8777
        • Recruiting
        • Research Site
      • Takasaki-shi, Japan, 370-0829
        • Recruiting
        • Research Site
      • Tsu-shi, Japan, 514-8507
        • Recruiting
        • Research Site
      • Yokohama City, Japan, 222-0036
        • Not yet recruiting
        • Research Site
      • Yokohama-shi, Japan, 241-8515
        • Recruiting
        • Research Site
      • Cheonan-si, Korea, Republic of, 31151
        • Recruiting
        • Research Site
      • Daegu, Korea, Republic of, 41404
        • Recruiting
        • Research Site
      • Goyang-si, Korea, Republic of, 10408
        • Recruiting
        • Research Site
      • Seongnam-si, Korea, Republic of, 13620
        • Recruiting
        • Research Site
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Research Site
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • Research Site
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Research Site
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Research Site
      • Seoul, Korea, Republic of, 02841
        • Recruiting
        • Research Site
      • Seoul, Korea, Republic of, 06273
        • Recruiting
        • Research Site
      • Seoul, Korea, Republic of, 5505
        • Recruiting
        • Research Site
      • Johor Bahru, Malaysia, 81100
        • Recruiting
        • Research Site
      • Kota Bharu, Malaysia, 16150
        • Not yet recruiting
        • Research Site
      • Kuala Lumpur, Malaysia, 50586
        • Recruiting
        • Research Site
      • Kuala Lumpur, Malaysia, 50603
        • Not yet recruiting
        • Research Site
      • Kuching, Malaysia, 93200
        • Recruiting
        • Research Site
      • Melaka, Malaysia, 75000
        • Not yet recruiting
        • Research Site
      • Pulau Pinang, Malaysia, 10450
        • Recruiting
        • Research Site
      • Alc. Cuauhtémoc, Mexico, 06100
        • Recruiting
        • Research Site
      • Alc. Cuauhtémoc, Mexico, 06700
        • Not yet recruiting
        • Research Site
      • Cancún, Mexico, 77500
        • Not yet recruiting
        • Research Site
      • Colonia Lindavista, Mexico, 7300
        • Not yet recruiting
        • Research Site
      • Estado de México, Mexico, 50090
        • Not yet recruiting
        • Research Site
      • Mexico, Mexico, 14080
        • Not yet recruiting
        • Research Site
      • Monterrey, Mexico, 64460
        • Not yet recruiting
        • Research Site
      • Monterrey, Mexico, 66220
        • Not yet recruiting
        • Research Site
      • Mérida, Mexico, 97300
        • Not yet recruiting
        • Research Site
      • Mérida, Mexico, 97300
        • Recruiting
        • Research Site
      • San Luis Potosí, Mexico, 78209
        • Recruiting
        • Research Site
      • Tuxtla Gutiérrez, Mexico, 29000
        • Not yet recruiting
        • Research Site
      • Veracruz, Mexico, 91851
        • Recruiting
        • Research Site
      • Auckland, New Zealand, 1023
        • Recruiting
        • Research Site
      • Hamilton, New Zealand, 3204
        • Recruiting
        • Research Site
      • Palmerston North, New Zealand, 4414
        • Recruiting
        • Research Site
      • Arequipa, Peru, AREQUIPA01
        • Recruiting
        • Research Site
      • La Libertad, Peru, 13013
        • Not yet recruiting
        • Research Site
      • Lima, Peru, 15023
        • Not yet recruiting
        • Research Site
      • Lima, Peru, LIMA 29
        • Not yet recruiting
        • Research Site
      • Lima, Peru, LIMA 01
        • Not yet recruiting
        • Research Site
      • Lima, Peru, Lima 34
        • Not yet recruiting
        • Research Site
      • Lima, Peru, 15076
        • Not yet recruiting
        • Research Site
      • Lima, Peru, Lima 13
        • Not yet recruiting
        • Research Site
      • Lima, Peru, 15073
        • Not yet recruiting
        • Research Site
      • San Isidro, Peru
        • Not yet recruiting
        • Research Site
      • Trujillo, Peru, 044
        • Recruiting
        • Research Site
      • Bacolod, Philippines, 6100
        • Recruiting
        • Research Site
      • Cebu City, Philippines, 6000
        • Recruiting
        • Research Site
      • Iloilo City, Philippines, 5000
        • Not yet recruiting
        • Research Site
      • Manila, Philippines, 1000
        • Not yet recruiting
        • Research Site
      • Quezon, Philippines, 1102
        • Recruiting
        • Research Site
      • Biała Podlaska, Poland, 21-500
        • Recruiting
        • Research Site
      • Białystok, Poland, 15-027
        • Recruiting
        • Research Site
      • Bydgoszcz, Poland, 85-796
        • Recruiting
        • Research Site
      • Gdańsk, Poland, 80-952
        • Recruiting
        • Research Site
      • Gdynia, Poland, 81-519
        • Recruiting
        • Research Site
      • Grudziadz, Poland, 86-300
        • Withdrawn
        • Research Site
      • Koszalin, Poland, 75-581
        • Recruiting
        • Research Site
      • Kraków, Poland, 31-501
        • Recruiting
        • Research Site
      • Lublin, Poland, 20-090
        • Withdrawn
        • Research Site
      • Lublin, Poland, 20-718
        • Withdrawn
        • Research Site
      • Opole, Poland, 45-061
        • Recruiting
        • Research Site
      • Poznań, Poland, 61-485
        • Withdrawn
        • Research Site
      • Racibórz, Poland, 47-400
        • Withdrawn
        • Research Site
      • Rzeszow, Poland, 35-055
        • Recruiting
        • Research Site
      • Rzeszów, Poland, 35-021
        • Recruiting
        • Research Site
      • Szczecin, Poland, 71-730
        • Withdrawn
        • Research Site
      • Tomaszów Mazowiecki, Poland, 97-200
        • Withdrawn
        • Research Site
      • Warszawa, Poland, 02-781
        • Recruiting
        • Research Site
      • Wroclaw, Poland, 53-413
        • Recruiting
        • Research Site
      • Łódź, Poland, 90-302
        • Recruiting
        • Research Site
      • Amadora, Portugal, 2720-276
        • Not yet recruiting
        • Research Site
      • Braga, Portugal, 4710-243
        • Not yet recruiting
        • Research Site
      • Lisboa, Portugal, 1998-018
        • Not yet recruiting
        • Research Site
      • Lisboa, Portugal, 1649-035
        • Not yet recruiting
        • Research Site
      • Matosinhos, Portugal, 4454-509
        • Not yet recruiting
        • Research Site
      • Porto, Portugal, 4200-072
        • Not yet recruiting
        • Research Site
      • Porto, Portugal, 4100-180
        • Not yet recruiting
        • Research Site
      • Viana do Castelo, Portugal, 4904-858
        • Not yet recruiting
        • Research Site
      • Vila Nova de Gaia, Portugal, 4434-502
        • Not yet recruiting
        • Research Site
      • Vila Real, Portugal, 5000-508
        • Not yet recruiting
        • Research Site
      • Rio Piedras, Puerto Rico, 00935
        • Recruiting
        • Research Site
      • Bucuresti, Romania, 011171
        • Recruiting
        • Research Site
      • Bucuresti, Romania, 013812
        • Recruiting
        • Research Site
      • Cluj Napoca, Romania, 400015
        • Recruiting
        • Research Site
      • Cluj-Napoca, Romania, 400641
        • Recruiting
        • Research Site
      • Craiova, Romania, 200094
        • Recruiting
        • Research Site
      • Craiova, Romania, 200385
        • Recruiting
        • Research Site
      • Craiova, Romania, 200542
        • Recruiting
        • Research Site
      • Floresti, Romania, 407280
        • Recruiting
        • Research Site
      • Iasi, Romania, 700106
        • Recruiting
        • Research Site
      • Oradea, Romania, 410469
        • Recruiting
        • Research Site
      • Otopeni, Romania, 075100
        • Recruiting
        • Research Site
      • Ovidiu, Romania, 905900
        • Recruiting
        • Research Site
      • Pitesti, Romania, 110283
        • Recruiting
        • Research Site
      • Sibiu, Romania, 550245
        • Recruiting
        • Research Site
      • Timisoara, Romania, 300239
        • Recruiting
        • Research Site
      • Timisoara, Romania, 300166
        • Recruiting
        • Research Site
      • Riyadh, Saudi Arabia, 12713
        • Not yet recruiting
        • Research Site
      • Riyadh, Saudi Arabia, 12713
        • Recruiting
        • Research Site
      • Riyadh/MENA, Saudi Arabia, 11426
        • Recruiting
        • Research Site
      • Belgrad, Serbia, 11000
        • Recruiting
        • Research Site
      • Belgrade, Serbia, 11000
        • Recruiting
        • Research Site
      • Belgrade, Serbia, 11080
        • Recruiting
        • Research Site
      • Beograd, Serbia, 11010
        • Not yet recruiting
        • Research Site
      • Kragujevac, Serbia, 34000
        • Recruiting
        • Research Site
      • Nis, Serbia, 18000
        • Recruiting
        • Research Site
      • Novi Sad, Serbia, 21000
        • Recruiting
        • Research Site
      • Valjevo, Serbia, 14000
        • Recruiting
        • Research Site
      • Zrenjanin, Serbia, 23000
        • Recruiting
        • Research Site
      • Amanzimtoti, South Africa, 4126
        • Not yet recruiting
        • Research Site
      • Bloemfontein, South Africa, 9301
        • Not yet recruiting
        • Research Site
      • Cape Town, South Africa, 7925
        • Not yet recruiting
        • Research Site
      • George, South Africa, 6529
        • Recruiting
        • Research Site
      • Johannesburg, South Africa, 2196
        • Recruiting
        • Research Site
      • Johannesburg, South Africa, 2193
        • Recruiting
        • Research Site
      • Pietermaritzburg, South Africa, 3245
        • Recruiting
        • Research Site
      • Port Elizabeth, South Africa, 6045
        • Recruiting
        • Research Site
      • Pretoria, South Africa, 31
        • Recruiting
        • Research Site
      • A Coruña, Spain, 15009
        • Recruiting
        • Research Site
      • Albacete, Spain, 02006
        • Recruiting
        • Research Site
      • Alicante, Spain, 03010
        • Recruiting
        • Research Site
      • Badalona, Spain, 08916
        • Recruiting
        • Research Site
      • Barakaldo, Spain, 48903
        • Recruiting
        • Research Site
      • Barcelona, Spain, 08041
        • Recruiting
        • Research Site
      • Barcelona, Spain, 08035
        • Recruiting
        • Research Site
      • Barcelona, Spain, 08036
        • Recruiting
        • Research Site
      • Barcelona, Spain, 08003
        • Recruiting
        • Research Site
      • Burgos, Spain, 09006
        • Recruiting
        • Research Site
      • Caceres, Spain, 10003
        • Recruiting
        • Research Site
      • Castello de la Plana, Spain, 12002
        • Recruiting
        • Research Site
      • Cordoba, Spain, 14004
        • Recruiting
        • Research Site
      • El Palmar, Spain, 30120
        • Recruiting
        • Research Site
      • Elche(Alicante), Spain, 03202
        • Recruiting
        • Research Site
      • Fuenlabrada, Spain, 28942
        • Recruiting
        • Research Site
      • Girona, Spain, 17007
        • Not yet recruiting
        • Research Site
      • Granada, Spain, 18016
        • Recruiting
        • Research Site
      • Granada, Spain, 18012
        • Recruiting
        • Research Site
      • Jerez de la Frontera, Spain, 11407
        • Recruiting
        • Research Site
      • La Coruña, Spain, 15006
        • Recruiting
        • Research Site
      • La Laguna (Tenerife), Spain, 38320
        • Recruiting
        • Research Site
      • Leon, Spain, 24008
        • Recruiting
        • Research Site
      • Lérida, Spain, 25198
        • Recruiting
        • Research Site
      • Madrid, Spain, 28007
        • Recruiting
        • Research Site
      • Madrid, Spain, 28034
        • Recruiting
        • Research Site
      • Madrid, Spain, 28040
        • Recruiting
        • Research Site
      • Madrid, Spain, 28041
        • Recruiting
        • Research Site
      • Madrid, Spain, 28033
        • Recruiting
        • Research Site
      • Madrid, Spain, 28050
        • Recruiting
        • Research Site
      • Madrid, Spain, 28009
        • Recruiting
        • Research Site
      • Malaga, Spain, 29010
        • Recruiting
        • Research Site
      • Manresa, Spain, 08243
        • Recruiting
        • Research Site
      • Murcia, Spain, 30008
        • Recruiting
        • Research Site
      • Málaga, Spain, 29016
        • Recruiting
        • Research Site
      • Palma de Mallorca, Spain, 07120
        • Recruiting
        • Research Site
      • Reus,Tarragona, Spain, 43204
        • Recruiting
        • Research Site
      • Sabadell, Spain, 08208
        • Recruiting
        • Research Site
      • Salamanca, Spain, 37007
        • Recruiting
        • Research Site
      • San Sebastian, Spain, 20014
        • Recruiting
        • Research Site
      • Sant Joan Despí, Spain, 08970
        • Recruiting
        • Research Site
      • Sevilla, Spain, 41009
        • Recruiting
        • Research Site
      • Sevilla, Spain, 41015
        • Recruiting
        • Research Site
      • Sevilla, Spain, 41014
        • Recruiting
        • Research Site
      • Toledo, Spain, 45007
        • Recruiting
        • Research Site
      • Valencia, Spain, 46010
        • Recruiting
        • Research Site
      • Valencia, Spain, 46015
        • Recruiting
        • Research Site
      • Valencia, Spain, 46009
        • Recruiting
        • Research Site
      • Vigo, Spain, 36312
        • Recruiting
        • Research Site
      • Zaragoza, Spain, 50009
        • Recruiting
        • Research Site
      • Baden, Switzerland, CH-5405
        • Recruiting
        • Research Site
      • Basel, Switzerland, 4031
        • Recruiting
        • Research Site
      • Bellinzona, Switzerland, 6500
        • Recruiting
        • Research Site
      • Chur, Switzerland, 7000
        • Recruiting
        • Research Site
      • Frauenfeld, Switzerland, 8501
        • Recruiting
        • Research Site
      • La Chaux-De-Fonds, Switzerland, 2300
        • Recruiting
        • Research Site
      • Lausanne, Switzerland, 1011
        • Recruiting
        • Research Site
      • Luzern, Switzerland, 6000
        • Recruiting
        • Research Site
      • Luzern, Switzerland, 6006
        • Recruiting
        • Research Site
      • St. Gallen, Switzerland, 9016
        • Recruiting
        • Research Site
      • Winterthur, Switzerland, 8401
        • Recruiting
        • Research Site
      • Zürich, Switzerland, 8008
        • Active, not recruiting
        • Research Site
      • Hsinchu, Taiwan, 300
        • Recruiting
        • Research Site
      • Kaohsiung, Taiwan, 833589
        • Recruiting
        • Research Site
      • New Taipei City, Taiwan, 23561
        • Recruiting
        • Research Site
      • Taichung, Taiwan, 40705
        • Recruiting
        • Research Site
      • Taichung, Taiwan, 404
        • Withdrawn
        • Research Site
      • Tainan, Taiwan, 70403
        • Recruiting
        • Research Site
      • Taipei, Taiwan, 10048
        • Recruiting
        • Research Site
      • Taipei, Taiwan, 11259
        • Recruiting
        • Research Site
      • Yong Kang City, Taiwan, 71004
        • Recruiting
        • Research Site
      • Bangkok, Thailand, 10210
        • Recruiting
        • Research Site
      • Bangkok, Thailand, 10400
        • Recruiting
        • Research Site
      • Bangkok, Thailand, 10330
        • Recruiting
        • Research Site
      • Bangkok, Thailand, 10700
        • Recruiting
        • Research Site
      • Hat Yai, Thailand, 90110
        • Recruiting
        • Research Site
      • Khon Kaen, Thailand, 40002
        • Recruiting
        • Research Site
      • Ankara, Turkey, 06010
        • Recruiting
        • Research Site
      • Ankara, Turkey, 06200
        • Recruiting
        • Research Site
      • Ankara, Turkey, 06530
        • Recruiting
        • Research Site
      • Ankara, Turkey, 06250
        • Withdrawn
        • Research Site
      • Antalya, Turkey, 07100
        • Recruiting
        • Research Site
      • Bursa, Turkey, 16059
        • Recruiting
        • Research Site
      • Cigli, Turkey, 35620
        • Recruiting
        • Research Site
      • Edirne, Turkey, 22030
        • Withdrawn
        • Research Site
      • Istanbul, Turkey, 34010
        • Withdrawn
        • Research Site
      • Istanbul, Turkey, 34093
        • Recruiting
        • Research Site
      • Istanbul, Turkey, 34180
        • Recruiting
        • Research Site
      • Istanbul, Turkey, 34722
        • Withdrawn
        • Research Site
      • Istanbul, Turkey, 34899
        • Withdrawn
        • Research Site
      • Karsiyaka, Turkey, 35575
        • Withdrawn
        • Research Site
      • Malatya, Turkey, 44280
        • Withdrawn
        • Research Site
      • Samsun, Turkey, 55200
        • Recruiting
        • Research Site
      • Çankaya, Turkey, 06680
        • Withdrawn
        • Research Site
      • İstanbul, Turkey, 34457
        • Recruiting
        • Research Site
      • Abu Dhabi, United Arab Emirates, 11241
        • Recruiting
        • Research Site
      • Al Ain, United Arab Emirates, 15258
        • Recruiting
        • Research Site
      • Dubai, United Arab Emirates, 505004
        • Recruiting
        • Research Site
      • Dubai, United Arab Emirates, 0000
        • Recruiting
        • Research Site
      • Aberdeen, United Kingdom, AB25 2ZN
        • Recruiting
        • Research Site
      • Bath, United Kingdom, BA1 3NG
        • Withdrawn
        • Research Site
      • Brighton, United Kingdom, BN2 5BD
        • Not yet recruiting
        • Research Site
      • Burton-on-Trent, United Kingdom, DE13 0RB
        • Recruiting
        • Research Site
      • Cambridge, United Kingdom, CB2 2QQ
        • Recruiting
        • Research Site
      • Derby, United Kingdom, DE22 3NE
        • Recruiting
        • Research Site
      • Guilford, United Kingdom, GU27XX
        • Recruiting
        • Research Site
      • Ipswich, United Kingdom, IP4 5PD
        • Recruiting
        • Research Site
      • Lancaster, United Kingdom, LA1 4RP
        • Recruiting
        • Research Site
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • Research Site
      • Leicester, United Kingdom, LE1 5WW
        • Recruiting
        • Research Site
      • Liverpool, United Kingdom, L7 8YA
        • Withdrawn
        • Research Site
      • London, United Kingdom, SE1 9RT
        • Recruiting
        • Research Site
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Research Site
      • London, United Kingdom, SW2 6JJ
        • Recruiting
        • Research Site
      • London, United Kingdom, EC1M 6BQ
        • Recruiting
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • Research Site
      • Northampton, United Kingdom, NN1 5BD
        • Recruiting
        • Research Site
      • Oxford, United Kingdom, OX3 7LE
        • Withdrawn
        • Research Site
      • Reading, United Kingdom, RG1 5AN
        • Withdrawn
        • Research Site
      • Shrewsbury, United Kingdom, SY3 8XQ
        • Recruiting
        • Research Site
      • Stockton, United Kingdom, TS19 8PE
        • Withdrawn
        • Research Site
      • Sutton, United Kingdom, SM2 5PT
        • Recruiting
        • Research Site
      • Sutton In Ashfield, United Kingdom, NG17 4JL
        • Recruiting
        • Research Site
      • Taunton, United Kingdom, TA1 5DA
        • Recruiting
        • Research Site
      • Warwick, United Kingdom, CV34 5BW
        • Withdrawn
        • Research Site
      • Whitchurch, United Kingdom, CF14 2TL
        • Recruiting
        • Research Site
    • Alabama
      • Dothan, Alabama, United States, 36303
        • Recruiting
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Research Site
      • Tucson, Arizona, United States, 85745
        • Recruiting
        • Research Site
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Recruiting
        • Research Site
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • Research Site
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • Research Site
      • Greenbrae, California, United States, 94904
        • Not yet recruiting
        • Research Site
      • Irvine, California, United States, 92618
        • Recruiting
        • Research Site
      • La Jolla, California, United States, 92093
        • Recruiting
        • Research Site
      • Los Angeles, California, United States, 90017
        • Recruiting
        • Research Site
      • Monterey, California, United States, 93940
        • Recruiting
        • Research Site
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • Research Site
      • West Hollywood, California, United States, 90048
        • Recruiting
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Research Site
      • Littleton, Colorado, United States, 80120
        • Recruiting
        • Research Site
      • Littleton, Colorado, United States, 80129
        • Recruiting
        • Research Site
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Research Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Not yet recruiting
        • Research Site
    • Florida
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • Research Site
      • Fort Myers, Florida, United States, 33901
        • Recruiting
        • Research Site
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • Research Site
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Research Site
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Research Site
      • Pembroke Pines, Florida, United States, 33028
        • Recruiting
        • Research Site
      • Plantation, Florida, United States, 33324
        • Recruiting
        • Research Site
      • Plantation, Florida, United States, 33322
        • Recruiting
        • Research Site
      • Saint Petersburg, Florida, United States, 33709
        • Recruiting
        • Research Site
      • Saint Petersburg, Florida, United States, 33705
        • Active, not recruiting
        • Research Site
      • Tallahassee, Florida, United States, 32308
        • Recruiting
        • Research Site
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Research Site
      • Atlanta, Georgia, United States, 30318
        • Recruiting
        • Research Site
      • Columbus, Georgia, United States, 31904
        • Recruiting
        • Research Site
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Research Site
      • Savannah, Georgia, United States, 31404
        • Recruiting
        • Research Site
      • Thomasville, Georgia, United States, 31792
        • Recruiting
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • Research Site
      • Elmhurst, Illinois, United States, 60126
        • Recruiting
        • Research Site
      • Naperville, Illinois, United States, 60540
        • Recruiting
        • Research Site
      • Park Ridge, Illinois, United States, 60068
        • Not yet recruiting
        • Research Site
      • Plainfield, Illinois, United States, 60585
        • Recruiting
        • Research Site
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Research Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Recruiting
        • Research Site
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Research Site
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Recruiting
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Research Site
    • Maine
      • Scarborough, Maine, United States, 04074
        • Recruiting
        • Research Site
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Recruiting
        • Research Site
      • Baltimore, Maryland, United States, 21201
        • Not yet recruiting
        • Research Site
      • Baltimore, Maryland, United States, 21287
        • Not yet recruiting
        • Research Site
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • Research Site
      • Lutherville, Maryland, United States, 21093
        • Not yet recruiting
        • Research Site
      • Towson, Maryland, United States, 21204
        • Recruiting
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Research Site
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Research Site
      • Hyannis, Massachusetts, United States, 02601
        • Not yet recruiting
        • Research Site
      • Worcester, Massachusetts, United States, 01655
        • Not yet recruiting
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Research Site
      • Flint, Michigan, United States, 48503
        • Not yet recruiting
        • Research Site
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Recruiting
        • Research Site
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Research Site
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Research Site
      • Saint Louis, Missouri, United States, 63131
        • Recruiting
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Recruiting
        • Research Site
      • Omaha, Nebraska, United States, 68198
        • Withdrawn
        • Research Site
      • Omaha, Nebraska, United States, 68124
        • Recruiting
        • Research Site
    • New Hampshire
      • Hooksett, New Hampshire, United States, 03106
        • Recruiting
        • Research Site
      • Lebanon, New Hampshire, United States, 03756
        • Not yet recruiting
        • Research Site
      • Manchester, New Hampshire, United States, 03103
        • Recruiting
        • Research Site
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Recruiting
        • Research Site
      • Farmington, New Mexico, United States, 87401
        • Recruiting
        • Research Site
    • New York
      • Bay Shore, New York, United States, 11706
        • Recruiting
        • Research Site
      • East Syracuse, New York, United States, 13057
        • Recruiting
        • Research Site
      • Greenlawn, New York, United States, 11740
        • Recruiting
        • Research Site
      • New Hyde Park, New York, United States, 11042
        • Recruiting
        • Research Site
      • New York, New York, United States, 10065
        • Withdrawn
        • Research Site
      • New York, New York, United States, 10065
        • Recruiting
        • Research Site
      • New York, New York, United States, 10029
        • Recruiting
        • Research Site
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Research Site
      • White Plains, New York, United States, 10601
        • Recruiting
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Research Site
      • Durham, North Carolina, United States, 27710
        • Not yet recruiting
        • Research Site
      • Greensboro, North Carolina, United States, 27403
        • Not yet recruiting
        • Research Site
      • Greenville, North Carolina, United States, 27834
        • Not yet recruiting
        • Research Site
      • Pinehurst, North Carolina, United States, 28374
        • Recruiting
        • Research Site
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • Research Site
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Research Site
    • Ohio
      • Blue Ash, Ohio, United States, 45242
        • Not yet recruiting
        • Research Site
      • Cincinnati, Ohio, United States, 45255
        • Recruiting
        • Research Site
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Research Site
      • Columbus, Ohio, United States, 43212
        • Recruiting
        • Research Site
      • Toledo, Ohio, United States, 43623
        • Not yet recruiting
        • Research Site
      • Youngstown, Ohio, United States, 44504
        • Not yet recruiting
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Not yet recruiting
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Research Site
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Research Site
      • Portland, Oregon, United States, 97225
        • Active, not recruiting
        • Research Site
    • Pennsylvania
      • Gettysburg, Pennsylvania, United States, 17325
        • Recruiting
        • Research Site
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • Research Site
      • Sayre, Pennsylvania, United States, 18840
        • Recruiting
        • Research Site
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Research Site
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Research Site
      • Rock Hill, South Carolina, United States, 29732
        • Recruiting
        • Research Site
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Research Site
    • South Dakota
      • Aberdeen, South Dakota, United States, 57401
        • Recruiting
        • Research Site
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Not yet recruiting
        • Research Site
      • Knoxville, Tennessee, United States, 37909
        • Recruiting
        • Research Site
      • Knoxville, Tennessee, United States, 37920
        • Recruiting
        • Research Site
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Research Site
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Research Site
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Research Site
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Research Site
      • Bedford, Texas, United States, 76022
        • Not yet recruiting
        • Research Site
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Research Site
      • Dallas, Texas, United States, 75231
        • Not yet recruiting
        • Research Site
      • Dallas, Texas, United States, 75230
        • Not yet recruiting
        • Research Site
      • El Paso, Texas, United States, 79902
        • Recruiting
        • Research Site
      • Flower Mound, Texas, United States, 75028
        • Recruiting
        • Research Site
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Research Site
      • Houston, Texas, United States, 77024
        • Recruiting
        • Research Site
      • Plano, Texas, United States, 75075
        • Not yet recruiting
        • Research Site
      • San Antonio, Texas, United States, 78217
        • Recruiting
        • Research Site
      • Tyler, Texas, United States, 75702
        • Recruiting
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Not yet recruiting
        • Research Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • Research Site
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Research Site
      • Midlothian, Virginia, United States, 23114
        • Recruiting
        • Research Site
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Research Site
      • Richmond, Virginia, United States, 23219
        • Not yet recruiting
        • Research Site
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Research Site
      • Winchester, Virginia, United States, 22601
        • Recruiting
        • Research Site
    • Washington
      • Puyallup, Washington, United States, 98373
        • Recruiting
        • Research Site
      • Spokane, Washington, United States, 99202
        • Recruiting
        • Research Site
      • Vancouver, Washington, United States, 98684
        • Recruiting
        • Research Site
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Not yet recruiting
        • Research Site
      • Morgantown, West Virginia, United States, 26505
        • Recruiting
        • Research Site
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • Recruiting
        • Research Site
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • Research Site
      • Milwaukee, Wisconsin, United States, 53215
        • Not yet recruiting
        • 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

  • 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 absence of any evidence of metastatic disease as defined in the protocol.
  • Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy.
  • Patients must be randomised within 12 months of definitive breast surgery.
  • Patients may have received up to 12 weeks of endocrine therapy prior to randomisation.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  • Adequate organ and bone marrow function

Exclusion Criteria:

  • 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 a very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation
  • Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance "
  • Known LVEF <50% with heart failure NYHA Grade ≥2.
  • Mean resting QTcF interval > 480 ms at screening
  • Concurrent exogenous reproductive hormone therapy or non topical hormonal therapy for non-cancer-related conditions
  • Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors ( eg, denosumab)
  • Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant
  • Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding.
  • Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-/peri-menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists that would preclude the patient from receiving any LHRH agonist.

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 ± abemaciclib
standard endocrine therapy of investigator's choice (aromatase inhibitors [AI; exemestane, letrozole, anastrozole] or tamoxifen) ± abemaciclib
Tamoxifen. Comparator. Administered orally
Anastrozole. Comparator. Administered orally
Letrozole. Comparator. Administered orally
Exemestane. Comparator. Administered orally
Abemaciclib adjuvant treatment Administered orally
Experimental: Arm B: camizestrant ± abemaciclib
camizestrant ± abemaciclib
Camizestrant. Experimental. Administered orally
Other Names:
  • AZD9833
Abemaciclib adjuvant treatment Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Invasive breast cancer-free survival (IBCFS)
Time Frame: Up to 14 years

IBCFS is defined as time from randomisation until date of first occurrence of:

  • Invasive ipsilateral breast tumour recurrence
  • Locoregional invasive breast cancer recurrence
  • Distant recurrence
  • Contralateral invasive breast cancer
  • Death attributable to any cause.
Up to 14 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distant relapse-free survival (DRFS)
Time Frame: Up to 14 years
DRFS is defined as time from randomisation until date of first distant recurrence or death from any cause, whichever occurs first.
Up to 14 years
Overall survival (OS)
Time Frame: Up to 14 years
OS is defined as time from randomisation until death from any cause.
Up to 14 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 7 years)
Until 28 days after the final dose of study treatment (up to 7 years)
Proportion of time on study treatment with high side-effect burden as measured by the PGI-TT.
Time Frame: Until 28 days after the final dose of study treatment (up to 7 years)
Until 28 days after the final dose of study treatment (up to 7 years)
Invasive disease-free survival (IDFS)
Time Frame: Up to 14 years

IDFS is defined as time from randomisation until date of first occurrence of one of the following events:

  • Invasive ipsilateral breast tumor recurrence
  • Locoregional invasive breast cancer recurrence
  • Distant recurrence
  • Contralateral invasive breast cancer
  • Second primary non-breast invasive cancer
  • Death attributable to any cause.
Up to 14 years
Change from baseline and time to deterioration of health-related quality of life as measured by the 2 global QoL items from the EORTC IL-311
Time Frame: Until 28 days after the final dose of study treatment (up to 7 years)
Until 28 days after the final dose of study treatment (up to 7 years)
Pharmacokinetics (PK)
Time Frame: Until 6 months from treatment start
Plasma concentrations of camizestrant pre-dose (trough concentration)
Until 6 months from treatment start

Collaborators and Investigators

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

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)

October 5, 2023

Primary Completion (Estimated)

March 4, 2030

Study Completion (Estimated)

May 6, 2037

Study Registration Dates

First Submitted

May 17, 2023

First Submitted That Met QC Criteria

July 11, 2023

First Posted (Actual)

July 19, 2023

Study Record Updates

Last Update Posted (Actual)

June 19, 2025

Last Update Submitted That Met QC Criteria

June 18, 2025

Last Verified

June 1, 2025

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 refer 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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