Breast Cancer, Early Breast CancerPhase 3CAMBRIA-2NCT05952557

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

A Phase 3 study testing Camizestrant, Tamoxifen and Anastrozole in people with Breast Cancer, Early Breast Cancer, run by AstraZeneca at 661 sites in 44 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Breast Cancer, Early Breast Cancer
What is being tested?: Camizestrant, Tamoxifen and Anastrozole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5,511 participants
Where: 661 sitesin 44 countries
Study dates: 5 Oct 2023to 6 May 2037
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Women and Men; ≥18 years at the time of screening (or per national guidelines)
Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with 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

Who cannot join

Inoperable locally advanced or metastatic breast cancer
Pathological complete response following treatment with neoadjuvant therapy
History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered 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

Show all 11Show fewer

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.

Trial locations and contacts

661 sites in 44 countries.

Country

City, postcode or hospital

661 sites in 44 countries

United States111 sites

Research Site
Aberdeen, South Dakota, 57401
Research Site
Albuquerque, New Mexico, 87109
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Annapolis, Maryland, 21401
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Appleton, Wisconsin, 54911
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Atlanta, Georgia, 30318
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Aurora, Colorado, 80045
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Austin, Texas, 78731
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Bay Shore, New York, 11706
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Bethesda, Maryland, 20817
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Boston, Massachusetts, 02111
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Boston, Massachusetts, 02115
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Charleston, South Carolina, 29425
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Charlotte, North Carolina, 28204
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Charlottesville, Virginia, 22908
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Chicago, Illinois, 60637
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Cincinnati, Ohio, 45255
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Clearwater, Florida, 33756
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Cleveland, Ohio, 44106
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Columbus, Ohio, 43212
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Dallas, Texas, 75246
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Des Moines, Iowa, 50309
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Detroit, Michigan, 48202
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Dothan, Alabama, 36303
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Duarte, California, 91010
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East Syracuse, New York, 13057
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El Paso, Texas, 79902
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Elmhurst, Illinois, 60126
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Fairfax, Virginia, 22031
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Farmington, New Mexico, 87401
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Fayetteville, Arkansas, 72703
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Flower Mound, Texas, 75028
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Fort Myers, Florida, 33901
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Fort Wayne, Indiana, 46804
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Fountain Valley, California, 92708
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Gainesville, Florida, 32610
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Gettysburg, Pennsylvania, 17325
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Greenlawn, New York, 11740
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Hershey, Pennsylvania, 17033
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Hooksett, New Hampshire, 03106
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Houston, Texas, 77024
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Irvine, California, 92618
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Jacksonville, Florida, 32224
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Kansas City, Missouri, 64111
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Knoxville, Tennessee, 37909
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Knoxville, Tennessee, 37920
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La Jolla, California, 92093
Research Site
Lincoln, Nebraska, 68506
Research Site
Littleton, Colorado, 80120
Research Site
Littleton, Colorado, 80129
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Los Angeles, California, 90017
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Louisville, Kentucky, 40202
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Madison, Wisconsin, 53792
Research Site
Manchester, New Hampshire, 03103
Research Site
Marietta, Georgia, 30060
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Memphis, Tennessee, 38120
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Midlothian, Virginia, 23114
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Minneapolis, Minnesota, 55416
Research Site
Morgantown, West Virginia, 26505
Research Site
Naperville, Illinois, 60540
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Nashville, Tennessee, 37203
Research Site
Nashville, Tennessee, 37232
Research Site
New Brunswick, New Jersey, 08901
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New Haven, Connecticut, 06510
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New Hyde Park, New York, 11042
Research Site
New Orleans, Louisiana, 70121
Research Site
New York, New York, 10029
Research Site
New York, New York, 10065
Research Site
Newark, Delaware, 19713
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Norfolk, Virginia, 23502
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Omaha, Nebraska, 68124
Research Site
Pembroke Pines, Florida, 33028
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Phoenix, Arizona, 85054
Research Site
Pinehurst, North Carolina, 28374
Research Site
Pittsburgh, Pennsylvania, 15213
Research Site
Plantation, Florida, 33322
Research Site
Plantation, Florida, 33324
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Portland, Oregon, 97210
Research Site
Portland, Oregon, 97213
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Portland, Oregon, 97225
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Puyallup, Washington, 98373
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Raleigh, North Carolina, 27607
Research Site
Roanoke, Virginia, 24014
Research Site
Rochester, Minnesota, 55905
Research Site
Rock Hill, South Carolina, 29732
Research Site
San Antonio, Texas, 78217
Research Site
Sayre, Pennsylvania, 18840
Research Site
Scarborough, Maine, 04074
Research Site
Sioux Falls, South Dakota, 57105
Research Site
Spartanburg, South Carolina, 29303
Research Site
Spokane, Washington, 99202
Research Site
St Louis, Missouri, 63110
Research Site
St Louis, Missouri, 63131
Research Site
St. Petersburg, Florida, 33705
Research Site
St. Petersburg, Florida, 33709
Research Site
Stony Brook, New York, 11794
Research Site
Tallahassee, Florida, 32308
Research Site
Thomasville, Georgia, 31792
Research Site
Towson, Maryland, 21204
Research Site
Tucson, Arizona, 85745
Research Site
Tyler, Texas, 75702
Research Site
Urbana, Illinois, 61801
Research Site
Vancouver, Washington, 98684
Research Site
Walnut Creek, California, 94598
Research Site
West Hollywood, California, 90048
Research Site
West Palm Beach, Florida, 33401
Research Site
White Plains, New York, 10601
Research Site
Winchester, Virginia, 22601
Research Site
Winston-Salem, North Carolina, 27103
Research Site
York, Pennsylvania, 17403
Research Site
Ypsilanti, Michigan, 48197

Other trials in United States

China60 sites

Research Site
Baoding, 071000
Research Site
Beijing, 100021
Research Site
Beijing, 100039
Research Site
Beijing, 100142
Research Site
Beijing, 100191
Research Site
Beijing, 100730
Research Site
Bengbu, 233004
Research Site
Binzhou, 256606
Research Site
Cangzhou, 061001
Research Site
Changchun, 130021
Research Site
Changsha, 410008
Research Site
Chengdu, 610042
Research Site
Chengdu, 610072
Research Site
Chifeng, 024000
Research Site
Foshan, 528000
Research Site
Fuzhou, 350014
Research Site
Guangzhou, 510060
Research Site
Haikou, 570311
Research Site
Hangzhou, 310000
Research Site
Hangzhou, 310009
Research Site
Hangzhou, 310016
Research Site
Hangzhou, 310022
Research Site
Harbin, 150081
Research Site
Hefei, 230001
Research Site
Hefei, 230012
Research Site
Hefei, 230022
Research Site
Hefei, 230601
Research Site
Hohhot, 010017
Research Site
Huizhou, 516001
Research Site
Jinzhou, 121001
Research Site
Lanzhou, 730050
Research Site
Linyi, 276000
Research Site
Liuzhou, 545005
Research Site
Liuzhou, 545006
Research Site
Nanchang, 330009
Research Site
Nanjing, 210029
Research Site
Nanning, 530021
Research Site
Nantong, 226001
Research Site
Neijiang, 641000
Research Site
Shandong, 250117
Research Site
Shangqiu, 476100
Research Site
Shantou, 515031
Research Site
Shaoguan Shi, 512025
Research Site
Shenyang, 110042
Research Site
Shenzhen, 518020
Research Site
Shijiazhuang, 050011
Research Site
Suining Shi, 629000
Research Site
Suzhou, 215004
Research Site
Suzhou, 215600
Research Site
Taizhou, 317000
Research Site
Tianjin, 300060
Research Site
Weifang, 261000
Research Site
Wuhan, 430060
Research Site
Wuhan, 430079
Research Site
Xi'an, 710004
Research Site
Xiangfan, 441021
Research Site
Xinxiang, 453100
Research Site
Xuzhou, 221002
Research Site
Xuzhou, 221009
Research Site
Zunyi, 563100

Other trials in China

Spain50 sites

Research Site
A Coruña, 15006
Research Site
A Coruña, 15009
Research Site
Albacete, 02006
Research Site
Alicante, 03010
Research Site
Badalona, 08916
Research Site
Barakaldo, 48903
Research Site
Barcelona, 08003
Research Site
Barcelona, 08035
Research Site
Barcelona, 08036
Research Site
Barcelona, 08041
Research Site
Burgos, 09006
Research Site
Cáceres, 10003
Research Site
Castellon, 12002
Research Site
Córdoba, 14004
Research Site
Donostia / San Sebastian, 20014
Research Site
El Palmar, 30120
Research Site
Elche(Alicante), 03202
Research Site
Fuenlabrada, 28942
Research Site
Girona, 17007
Research Site
Granada, 18012
Research Site
Granada, 18016
Research Site
Jerez de la Frontera, 11407
Research Site
La Laguna (Tenerife), 38320
Research Site
León, 24008
Research Site
Lleida, 25198
Research Site
Madrid, 28007
Research Site
Madrid, 28009
Research Site
Madrid, 28033
Research Site
Madrid, 28034
Research Site
Madrid, 28040
Research Site
Madrid, 28041
Research Site
Madrid, 28050
Research Site
Málaga, 29010
Research Site
Málaga, 29016
Research Site
Manresa, 08243
Research Site
Murcia, 30008
Research Site
Palma de Mallorca, 07120
Research Site
Reus, 43204
Research Site
Sabadell, 08208
Research Site
Salamanca, 37007
Research Site
Sant Joan Despí, 08970
Research Site
Seville, 41009
Research Site
Seville, 41014
Research Site
Seville, 41015
Research Site
Toledo, 45007
Research Site
Valencia, 46009
Research Site
Valencia, 46010
Research Site
Valencia, 46015
Research Site
Vigo, 36312
Research Site
Zaragoza, 50009

Other trials in Spain

Japan33 sites

Research Site
Bunkyō City, 113-8431
Research Site
Chiba, 260-8717
Research Site
Chūōku, 104-8560
Research Site
Fukuoka, 811-1395
Research Site
Fukushima, 960-1295
Research Site
Hirakata-shi, 573-1191
Research Site
Hiroshima, 730-8518
Research Site
Iruma-Gun, 350-0495
Research Site
Isehara-shi, 259-1193
Research Site
Kagoshima, 892-0833
Research Site
Kamogawa-shi, 296-0041
Research Site
Kōtoku, 135-8550
Research Site
Kumamoto, 860-8556
Research Site
Kurume-shi, 830-0013
Research Site
Kyoto, 606-8507
Research Site
Matsuyama, 791-0280
Research Site
Nagoya, 464-8681
Research Site
Nagoya, 466-8550
Research Site
Nagoya, 467-0001
Research Site
Niigata, 951-8566
Research Site
Osaka, 541-8567
Research Site
Ota-shi, 373-8550
Research Site
Sapporo, 003-0804
Research Site
Sapporo, 060-8638
Research Site
Sendai
Research Site
Shinagawa-ku, 142-8666
Research Site
Suita-shi, 565-0871
Research Site
Sunto-gun, 411-8777
Research Site
Takasaki-shi, 370-0829
Research Site
Tsu, 514-8507
Research Site
Utsunomiya, 320-0834
Research Site
Yokohama, 222-0036
Research Site
Yokohama, 241-8515

Other trials in Japan

Brazil31 sites

Research Site
Alfenas, 37130-000
Research Site
Belo Horizonte, 30130-100
Research Site
Blumenau, 89010-340
Research Site
Brasília, 71615-907
Research Site
Curitiba, 80730-380
Research Site
Curitiba, 80810-050
Research Site
Fortaleza, 60135-237
Research Site
Fortaleza, 60430-230
Research Site
Goiânia, 74000-000
Research Site
Itajaí, 88301-220
Research Site
João Pessoa, 58013-140
Research Site
Natal, 59075-740
Research Site
Porto Alegre, 90035-001
Research Site
Porto Alegre, 90050-170
Research Site
Porto Alegre, 90610000
Research Site
Porto Velho, 76834-899
Research Site
Pouso Alegre, 37554-216
Research Site
Recife, 50070-480
Research Site
Ribeirão Preto, 14015-130
Research Site
Rio de Janeiro, 20560-120
Research Site
Rio de Janeiro, 22793-080
Research Site
Salvador, 40170-110
Research Site
Santo André, 09060-650
Research Site
São Paulo, 01246-000
Research Site
São Paulo, 01327-001
Research Site
São Paulo, 01409-902
Research Site
São Paulo, 03102-006
Research Site
Taubaté, 12030-200
Research Site
Teresina, 64049-200
Research Site
Três Lagoas, 79601-001
Research Site
Vitória, 29043-260

Other trials in Brazil

Germany27 sites

Research Site
Aachen, 52074
Research Site
Berlin, 12559
Research Site
Cologne, 51067
Research Site
Darmstadt, 64283
Research Site
Deggendorf, 94469
Research Site
Dessau, 6847
Research Site
Düsseldorf, 40235
Research Site
Essen, 45130
Research Site
Georgsmarienhütte, 49124
Research Site
Hamburg, 20357
Research Site
Hamburg, 22457
Research Site
Hanover, 30177
Research Site
Hanover, 30559
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Heidelberg, 69120
Research Site
Karlsruhe, 76135
Research Site
Koblenz, 56068
Research Site
Mainz, 55131
Research Site
Offenburg, 77654
Research Site
Rostock, 18057
Research Site
Saarbrücken, 66113
Research Site
Schweinfurt, 97421
Research Site
Torgau, 4860
Research Site
Wiesbaden, 65189
Research Site
Wiesbaden, 65199
Research Site
Witten, 58452
Research Site
Worms, 67550
Research Site
Wuppertal, 42283

Other trials in Germany

Australia24 sites

Research Site
Bankstown, 2200
Research Site
Bendigo, 3550
Research Site
Bowral, 2576
Research Site
Brighton, 3186
Research Site
Clayton, 3168
Research Site
Coffs Harbour, 2450
Research Site
Fitzroy, 3065
Research Site
Frankston, 3199
Research Site
Garran, 2605
Research Site
Gateshead, 2290
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Heidelberg, 3084
Research Site
Liverpool, 2170
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Melbourne, 3004
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Murdoch, WA6150
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Randwick, 2031
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Richmond, 3121
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Shepparton, 3630
Research Site
South Brisbane, 4101
Research Site
St Leonards, 2065
Research Site
Subiaco, 6008
Research Site
Wangaratta, 3677
Research Site
Waratah, 2298
Research Site
Warnnambool, 3280
Research Site
Wollongong, 2500

Other trials in Australia

France23 sites

Research Site
Angers, 49100
Research Site
Bordeaux, 33076
Research Site
Caen, 14076
Research Site
Clermont-Ferrand, 63000
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Dijon, 21000
Research Site
Epagny Metz-Tessy, 74370
Research Site
Lille, 59000
Research Site
Lyon, 75004
Research Site
Marseille, 13273
Research Site
Montpellier, 34298
Research Site
Nantes, 44277
Research Site
Nîmes, 30029
Research Site
Paris, 75005
Research Site
Pierre-Bénite, 69495
Research Site
Rennes, 35000
Research Site
Rouen, 76021
Research Site
Saint-Cloud, 92210
Research Site
Saint-Herblain, 44800
Research Site
Saint-Priest-en-Jarez, 42270
Research Site
Strasbourg, 67200
Research Site
Toulouse, 31059
Research Site
Vandœuvre-lès-Nancy, 54519
Research Site
Villejuif, 94805

Other trials in France

United Kingdom20 sites

Research Site
Aberdeen, AB25 2ZN
Research Site
Burton-on-Trent, DE13 0RB
Research Site
Cambridge, CB2 2QQ
Research Site
Derby, DE22 3NE
Research Site
Guildford, GU27XX
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Ipswich, IP4 5PD
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Lancaster, LA1 4RP
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Leeds, LS9 7TF
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Leicester, LE1 5WW
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London, EC1M 6BQ
Research Site
London, NW3 2QG
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London, SE1 9RT
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London, SW2 6JJ
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Manchester, M20 4BX
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Northampton, NN1 5BD
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Shrewsbury, SY3 8XQ
Research Site
Sutton, SM2 5PT
Research Site
Sutton in Ashfield, NG17 4JL
Research Site
Taunton, TA1 5DA
Research Site
Whitchurch, CF14 2TL

Other trials in United Kingdom

Italy17 sites

Research Site
Bergamo, 24127
Research Site
Bologna, 40138
Research Site
Florence, 50134
Research Site
Genoa, 16132
Research Site
Meldola, 47014
Research Site
Milan, 20132
Research Site
Milan, 20141
Research Site
Misterbianco, 95045
Research Site
Monza, 20900
Research Site
Naples, 80131
Research Site
Novara, 28100
Research Site
Padova, 35128
Research Site
Roma, 00161
Research Site
Roma, 00168
Research Site
Rozzano, 20089
Research Site
Torino, 10126
Research Site
Trento, 38100

Other trials in Italy

Canada15 sites

Research Site
Barrie, Ontario, L4M 6M2
Research Site
Calgary, Alberta, T2N 4N2
Research Site
Chicoutimi, Quebec, G7H 5H6
Research Site
Edmonton, Alberta, t6G1Z2
Research Site
Greater Sudbury, Ontario, P3E 5J1
Research Site
Kelowna, British Columbia, V1Y 5L3
Research Site
Kingston, Ontario, K7L 2V7
Research Site
Lévis, Quebec, G6V 3Z1
Research Site
Montreal, Quebec, H1T 2M4
Research Site
Montreal, Quebec, H2X 3E4
Research Site
Montreal, Quebec, H4A 3J1
Research Site
North Vancouver, British Columbia, V7L 2L7
Research Site
Québec, Quebec, G1S 4L8
Research Site
Saskatoon, Saskatchewan, S7N 4H4
Research Site
Thunder Bay, Ontario, P7B 6V4

Other trials in Canada

India15 sites

Research Site
Ansārinagar, 110 029
Research Site
Bangalore, 560064
Research Site
Dehradun, 248016
Research Site
Delhi, 110088
Research Site
Kolkata, 700160
Research Site
Kozhikode, 673 601
Research Site
Mumbai, 400612
Research Site
Mysuru, 570017
Research Site
Nagpur, 440001
Research Site
Nashik, 422 009
Research Site
Nashik, 422002
Research Site
New Delhi, 110 085
Research Site
New Delhi, 110029
Research Site
New Delhi, 110075
Research Site
Surat, 395002

Other trials in India

Greece14 sites

Research Site
Athens, 115 22
Research Site
Athens, 11527, GR
Research Site
Athens, 11528
Research Site
Athens, 12462
Research Site
Heraklion, 71110
Research Site
Ioannina, 455 00
Research Site
Larissa, 41335, GR
Research Site
Marousi, 151 23
Research Site
Piraeus, 185 37
Research Site
Rio, 265 04
Research Site
Thessaloniki, 546 39
Research Site
Thessaloniki, 552 36
Research Site
Thessaloniki, 56403
Research Site
Thessaloniki, 570 01

Other trials in Greece

Poland13 sites

Research Site
Biała Podlaska, 21-500
Research Site
Bialystok, 15-027
Research Site
Bydgoszcz, 85-796
Research Site
Gdansk, 80-952
Research Site
Gdynia, 81-519
Research Site
Koszalin, 75-581
Research Site
Krakow, 31-501
Research Site
Lodz, 90-302
Research Site
Opole, 45-061
Research Site
Rzeszów, 35-021
Research Site
Rzeszów, 35-055
Research Site
Warsaw, 02-781
Research Site
Wroclaw, 53-413

Other trials in Poland

Argentina12 sites

Research Site
CABA, C1061
Research Site
Capital Federal, 1118
Research Site
Ciudad de Buenos Aires, 1426
Research Site
Ciudad de Buenos Aires, C1025ABI
Research Site
Ciudad de Buenos Aires, C1426ANZ
Research Site
Córdoba, 5001
Research Site
Córdoba, X5800HHW
Research Site
La Plata, 1900
Research Site
Rosario, 2123
Research Site
San Juan, 5400
Research Site
San Miguel de Tucumán, 4000
Research Site
Viedma, R8500ACE

Other trials in Argentina

Austria12 sites

Research Site
Graz, 8036
Research Site
Innsbruck, 6020
Research Site
Linz, 4010
Research Site
Linz, 4021
Research Site
Salzburg, 5020
Research Site
Sankt Veit an der Glan, 9300
Research Site
Steyr, 4400
Research Site
Vienna, 1090
Research Site
Vienna, 1130
Research Site
Vienna, 1160
Research Site
Wels, 4600
Research Site
Wiener Neustadt, 2700

Other trials in Austria

Hungary12 sites

Research Site
Budapest, 1082
Research Site
Budapest, 1122
Research Site
Debrecen, 4032
Research Site
Gyula, 5700
Research Site
Kaposvár, 7400
Research Site
Kecskemét, 6000
Research Site
Miskolc, 3526
Research Site
Nyíregyháza, 4400
Research Site
Salgótarján, 3100
Research Site
Szeged, 6725
Research Site
Szekszárd, 7100
Research Site
Zalaegerszeg, 8900

Other trials in Hungary

Switzerland12 sites

Research Site
Baden, CH-5405
Research Site
Basel, 4031
Research Site
Bellinzona, 6500
Research Site
Chur, 7000
Research Site
Frauenfeld, 8501
Research Site
La Chaux-de-Fonds, 2300
Research Site
Lausanne, 1011
Research Site
Lucerne, 6000
Research Site
Lucerne, 6006
Research Site
Sankt Gallen, 9016
Research Site
Winterthur, 8401
Research Site
Zurich, 8008

Other trials in Switzerland

Romania11 sites

Research Site
Bucharest, 011171
Research Site
Bucharest, 013812
Research Site
Cluj-Napoca, 400015
Research Site
Craiova, 200094
Research Site
Craiova, 200385
Research Site
Craiova, 200542
Research Site
Floreşti, 407280
Research Site
Otopeni, 075100
Research Site
Ovidiu, 905900
Research Site
Piteşti, 110283
Research Site
Timișoara, 300239

Other trials in Romania

South Korea11 sites

Research Site
Cheonan-si, 31151
Research Site
Daegu, 41404
Research Site
Goyang-si, 10408
Research Site
Seongnam-si, 13620
Research Site
Seoul, 02841
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 06273
Research Site
Seoul, 06351
Research Site
Seoul, 06591
Research Site
Seoul, 5505

Other trials in South Korea

Belgium10 sites

Research Site
Aalst, 9300
Research Site
Anderlecht, 1070
Research Site
Brasschaat, 2930
Research Site
Brussels, 1200
Research Site
Charleroi, 6000
Research Site
Edegem, 2650
Research Site
Ghent, 9000
Research Site
Leuven, 3000
Research Site
Namur, 5000
Research Site
Wilrijk, 2610

Other trials in Belgium

Turkey (Türkiye)10 sites

Research Site
Ankara, 06010
Research Site
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About this study

Official title: 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

Read the 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.

Conditions: Breast Cancer, Early Breast Cancer
Being tested: Camizestrant, Tamoxifen, Anastrozole, Letrozole, Exemestane
Keywords: ER+, HER2-, breast cancer
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CamizestrantDrug
Also called AZD9833
Camizestrant. Experimental. Administered orally
TamoxifenDrug
Tamoxifen. Comparator. Administered orally
AnastrozoleDrug
Anastrozole. Comparator. Administered orally
LetrozoleDrug
Letrozole. Comparator. Administered orally
ExemestaneDrug
Exemestane. Comparator. Administered orally
AbemaciclibDrug
Abemaciclib adjuvant treatment Administered orally

Study groups in NCT05952557
Study group	Role	What they receive
Arm A: standard endocrine therapy of investigator´s choice ± abemaciclib	Active comparator	standard endocrine therapy of investigator's choice (aromatase inhibitors [AI; exemestane, letrozole, anastrozole] or tamoxifen) ± abemaciclib Receives: Drug: Tamoxifen; Drug: Anastrozole; Drug: Letrozole; Drug: Exemestane; Drug: Abemaciclib
Arm B: camizestrant ± abemaciclib	Experimental	camizestrant ± abemaciclib Receives: Drug: Camizestrant; Drug: Abemaciclib

What is being measured

The primary outcome is the main question the study is designed to answer.

Invasive breast cancer-free survival (IBCFS)
IBCFS is defined as time from randomisation until date of first occurrence of:
- Invasive ipsilateral breast tumour recurrence
- Locoregional invasive breast cancer recurrence
- Distant recurrence
- Contralateral invasive breast cancer
- Death attributable to any cause.
Measured: Up to 14 years

Secondary outcomes (7)

Invasive disease-free survival (IDFS)
IDFS is defined as time from randomisation until date of first occurrence of one of the following events:
- Invasive ipsilateral breast tumor recurrence
- Locoregional invasive breast cancer recurrence
- Distant recurrence
- Contralateral invasive breast cancer
- Second primary non-breast invasive cancer
- Death attributable to any cause.
Measured: Up to 14 years
Distant relapse-free survival (DRFS)
DRFS is defined as time from randomisation until date of first distant recurrence or death from any cause, whichever occurs first.
Measured: Up to 14 years
Overall survival (OS)
OS is defined as time from randomisation until death from any cause.
Measured: 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)
Measured: 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.
Measured: Until 28 days after the final dose of study treatment (up to 7 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
Measured: Until 28 days after the final dose of study treatment (up to 7 years)
Pharmacokinetics (PK)
Plasma concentrations of camizestrant pre-dose (trough concentration)
Measured: Until 6 months from treatment start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Oct 20236 May 2037

First posted19 Jul 2023
Study start5 Oct 2023
Primary completion4 Mar 2030 (estimated)
Study completion6 May 2037 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast Cancer, Early Breast CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Patients will be randomised in a 1:1 ratio to one of the following arms: • Arm A: Standard ET of investigator's choice (aromatase inhibitors \[AI; exemestane, letrozole, anastrozole\] or tamoxifen) ± abemaciclib • Arm B: Camizestrant ± abemaciclib
Masking: None (open label)
Enrolment: 5,511 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05952557
Sponsor's protocol ID: D8535C00001
Other IDs: 2023-504031-41-00, 2023
Acronym: CAMBRIA-2
Status last verified: Aug 2026
First submitted: 17 May 2023
Last updated: 10 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Publications

Hamilton EP, Loibl S, Bachelot T, Gnant M, Niikura N, Park YH, Tolaney SM, Pistilli B, Rastogi P, Saini KS, Gioni I, Johnston S, Nunes R, Quintana A, Stuart M, Syta E, Walding A, Klinowska T, Mayer IA. CAMBRIA-1 & CAMBRIA-2 phase III trials: camizestrant versus standard endocrine therapy in ER+/HER2- early breast cancer. Future Oncol. 2025 Mar;21(7):795-806. doi: 10.1080/14796694.2025.2459548. Epub 2025 Feb 27.
PubMed 40017004

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05952557
Acronym / sponsor ID: CAMBRIA-2 / D8535C00001
Conditions: Breast Cancer, Early Breast Cancer
Keywords: ER+, HER2-, breast cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 5,511 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Austrian Breast & Colorectal Cancer Study Group
Study start: 5 Oct 2023 (actual)
Primary completion: 4 Mar 2030 (estimated)
Study completion: 6 May 2037 (estimated)
First posted: 19 Jul 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Patients will be followed for 10 years from randomization of the last patient.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Patients will be randomised in a 1:1 ratio to one of the following arms: • Arm A: Standard ET of investigator's choice (aromatase inhibitors [AI; exemestane, letrozole, anastrozole] or tamoxifen) ± abemaciclib • Arm B: Camizestrant ± abemaciclib

Arm	Type	Receives
Arm A: standard endocrine therapy of investigator´s choice ± abemaciclib	Active comparator	Drug: Tamoxifen, Drug: Anastrozole, Drug: Letrozole, Drug: Exemestane, Drug: Abemaciclibstandard endocrine therapy of investigator's choice (aromatase inhibitors [AI; exemestane, letrozole, anastrozole] or tamoxifen) ± abemaciclib
Arm B: camizestrant ± abemaciclib	Experimental	Drug: Camizestrant, Drug: Abemaciclibcamizestrant ± abemaciclib

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CamizestrantAlso: AZD9833Camizestrant. Experimental. Administered orally	Drug	Arm B: camizestrant ± abemaciclib
TamoxifenTamoxifen. Comparator. Administered orally	Drug	Arm A: standard endocrine therapy of investigator´s choice ± abemaciclib
AnastrozoleAnastrozole. Comparator. Administered orally	Drug	Arm A: standard endocrine therapy of investigator´s choice ± abemaciclib
LetrozoleLetrozole. Comparator. Administered orally	Drug	Arm A: standard endocrine therapy of investigator´s choice ± abemaciclib
ExemestaneExemestane. Comparator. Administered orally	Drug	Arm A: standard endocrine therapy of investigator´s choice ± abemaciclib
AbemaciclibAbemaciclib adjuvant treatment Administered orally	Drug	Arm A: standard endocrine therapy of investigator´s choice ± abemaciclib, Arm B: camizestrant ± abemaciclib

Primary outcome

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.

7 secondary outcomes

Invasive disease-free survival (IDFS)
Time frame: Up to 14 years
Distant relapse-free survival (DRFS)
Time frame: Up to 14 years
Overall survival (OS)
Time frame: 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)
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)
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)
Pharmacokinetics (PK)
Time frame: Until 6 months from treatment start

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
Derived from this study: PubMed 40017004Hamilton EP, Loibl S, Bachelot T, Gnant M, Niikura N, Park YH, Tolaney SM, Pistilli B, Rastogi P, Saini KS, Gioni I, Johnston S, Nunes R, Quintana A, Stuart M, Syta E, Walding A, Klinowska T, Mayer IA. CAMBRIA-1 & CAMBRIA-2 phase III trials: camizestrant versus standard endocrine therapy in ER+/HER2- early breast cancer. Future Oncol. 2025 Mar;21(7):795-806. doi: 10.1080/14796694.2025.2459548. Epub 2025 Feb 27.
Breast Cancer Study Locator details (for US)Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

661 sites in 44 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Camizestrant, Tamoxifen and Anastrozole in people with Breast Cancer, Early Breast Cancer, run by AstraZeneca at 661 sites in 44 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 661 sites in United States, China, Spain, Japan, Brazil and 39 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Invasive breast cancer-free survival (IBCFS) (time frame: Up to 14 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05952557, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.