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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05952557




Registration number
NCT05952557
Ethics application status
Date submitted
17/05/2023
Date registered
19/07/2023
Date last updated
5/11/2024

Titles & IDs
Public title
An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)
Scientific 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
Secondary ID [1] 0 0
2023-504031-41-00
Secondary ID [2] 0 0
D8535C00001
Universal Trial Number (UTN)
Trial acronym
CAMBRIA-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer, Early Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Camizestrant
Treatment: Drugs - Tamoxifen
Treatment: Drugs - Anastrozole
Treatment: Drugs - Letrozole
Treatment: Drugs - Exemestane
Treatment: Drugs - Abemaciclib

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

Experimental: Arm B: camizestrant ± abemaciclib - camizestrant ± abemaciclib


Treatment: Drugs: Camizestrant
Camizestrant. Experimental. Administered orally

Treatment: Drugs: Tamoxifen
Tamoxifen. Comparator. Administered orally

Treatment: Drugs: Anastrozole
Anastrozole. Comparator. Administered orally

Treatment: Drugs: Letrozole
Letrozole. Comparator. Administered orally

Treatment: Drugs: Exemestane
Exemestane. Comparator. Administered orally

Treatment: Drugs: Abemaciclib
Abemaciclib adjuvant treatment Administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Invasive breast cancer-free survival (IBCFS)
Timepoint [1] 0 0
Up to 14 years
Secondary outcome [1] 0 0
Invasive disease-free survival (IDFS)
Timepoint [1] 0 0
Up to 14 years
Secondary outcome [2] 0 0
Distant relapse-free survival (DRFS)
Timepoint [2] 0 0
Up to 14 years
Secondary outcome [3] 0 0
Overall survival (OS)
Timepoint [3] 0 0
Up to 14 years
Secondary outcome [4] 0 0
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)
Timepoint [4] 0 0
Until 28 days after the final dose of study treatment (up to 7 years)
Secondary outcome [5] 0 0
Proportion of time on study treatment with high side-effect burden as measured by the PGI-TT.
Timepoint [5] 0 0
Until 28 days after the final dose of study treatment (up to 7 years)
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Until 28 days after the final dose of study treatment (up to 7 years)
Secondary outcome [7] 0 0
Pharmacokinetics (PK)
Timepoint [7] 0 0
Until 6 months from treatment start

Eligibility
Key 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
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
6/05/2037
Actual
Sample size
Target
5500
Accrual to date
Final
Recruitment in Australia
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5081 - Adelaide
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2500 - Wollongong
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France
State/province [187] 0 0
Montpellier
Country [188] 0 0
France
State/province [188] 0 0
Nantes
Country [189] 0 0
France
State/province [189] 0 0
Nimes
Country [190] 0 0
France
State/province [190] 0 0
Pierre Benite
Country [191] 0 0
France
State/province [191] 0 0
Plerin SUR MER
Country [192] 0 0
France
State/province [192] 0 0
Rennes
Country [193] 0 0
France
State/province [193] 0 0
Rouen
Country [194] 0 0
France
State/province [194] 0 0
Saint Herblain
Country [195] 0 0
France
State/province [195] 0 0
Saint-Priest-En-Jarez
Country [196] 0 0
France
State/province [196] 0 0
Strasbourg
Country [197] 0 0
France
State/province [197] 0 0
Toulouse
Country [198] 0 0
France
State/province [198] 0 0
Vandoeuvre les Nancy
Country [199] 0 0
France
State/province [199] 0 0
Villejuif Cedex
Country [200] 0 0
Georgia
State/province [200] 0 0
Batumi
Country [201] 0 0
Georgia
State/province [201] 0 0
Tbilisi
Country [202] 0 0
Germany
State/province [202] 0 0
Aachen
Country [203] 0 0
Germany
State/province [203] 0 0
Berlin
Country [204] 0 0
Germany
State/province [204] 0 0
Darmstadt
Country [205] 0 0
Germany
State/province [205] 0 0
Deggendorf
Country [206] 0 0
Germany
State/province [206] 0 0
Dessau-Rosslau
Country [207] 0 0
Germany
State/province [207] 0 0
Dresden
Country [208] 0 0
Germany
State/province [208] 0 0
Düsseldorf
Country [209] 0 0
Germany
State/province [209] 0 0
Essen
Country [210] 0 0
Germany
State/province [210] 0 0
Freudenstadt
Country [211] 0 0
Germany
State/province [211] 0 0
Georgsmarienhuette
Country [212] 0 0
Germany
State/province [212] 0 0
Hamburg
Country [213] 0 0
Germany
State/province [213] 0 0
Hamm
Country [214] 0 0
Germany
State/province [214] 0 0
Hanau
Country [215] 0 0
Germany
State/province [215] 0 0
Hannover
Country [216] 0 0
Germany
State/province [216] 0 0
Heidelberg
Country [217] 0 0
Germany
State/province [217] 0 0
Karlsruhe
Country [218] 0 0
Germany
State/province [218] 0 0
Koblenz
Country [219] 0 0
Germany
State/province [219] 0 0
Köln
Country [220] 0 0
Germany
State/province [220] 0 0
Mainz
Country [221] 0 0
Germany
State/province [221] 0 0
Nurtingen
Country [222] 0 0
Germany
State/province [222] 0 0
Offenburg
Country [223] 0 0
Germany
State/province [223] 0 0
Rostock
Country [224] 0 0
Germany
State/province [224] 0 0
Saarbrücken
Country [225] 0 0
Germany
State/province [225] 0 0
Schweinfurt
Country [226] 0 0
Germany
State/province [226] 0 0
Speyer
Country [227] 0 0
Germany
State/province [227] 0 0
Torgau
Country [228] 0 0
Germany
State/province [228] 0 0
Wiesbaden
Country [229] 0 0
Germany
State/province [229] 0 0
Witten
Country [230] 0 0
Germany
State/province [230] 0 0
Worms
Country [231] 0 0
Germany
State/province [231] 0 0
Wuppertal
Country [232] 0 0
Greece
State/province [232] 0 0
Athens
Country [233] 0 0
Greece
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Heraklion
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Greece
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Ioannina
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Greece
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Larissa
Country [236] 0 0
Greece
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Marousi
Country [237] 0 0
Greece
State/province [237] 0 0
Piraeus
Country [238] 0 0
Greece
State/province [238] 0 0
Rio
Country [239] 0 0
Greece
State/province [239] 0 0
Thessaloniki
Country [240] 0 0
Hungary
State/province [240] 0 0
Budapest
Country [241] 0 0
Hungary
State/province [241] 0 0
Debrecen
Country [242] 0 0
Hungary
State/province [242] 0 0
Gyula
Country [243] 0 0
Hungary
State/province [243] 0 0
Gyor
Country [244] 0 0
Hungary
State/province [244] 0 0
Kaposvár
Country [245] 0 0
Hungary
State/province [245] 0 0
Kecskemét
Country [246] 0 0
Hungary
State/province [246] 0 0
Miskolc
Country [247] 0 0
Hungary
State/province [247] 0 0
Nyíregyháza
Country [248] 0 0
Hungary
State/province [248] 0 0
Salgotarjan
Country [249] 0 0
Hungary
State/province [249] 0 0
Szekszárd
Country [250] 0 0
Hungary
State/province [250] 0 0
Zalaegerszeg
Country [251] 0 0
India
State/province [251] 0 0
Ansari Nagar
Country [252] 0 0
India
State/province [252] 0 0
Bangalore
Country [253] 0 0
India
State/province [253] 0 0
Belgavi
Country [254] 0 0
India
State/province [254] 0 0
Delhi
Country [255] 0 0
India
State/province [255] 0 0
Dhanvantari Nagar
Country [256] 0 0
India
State/province [256] 0 0
Gurgaon
Country [257] 0 0
India
State/province [257] 0 0
Kanpur
Country [258] 0 0
India
State/province [258] 0 0
Kolkata
Country [259] 0 0
India
State/province [259] 0 0
Mysuru
Country [260] 0 0
India
State/province [260] 0 0
Nagpur
Country [261] 0 0
India
State/province [261] 0 0
Nashik
Country [262] 0 0
India
State/province [262] 0 0
New Delhi
Country [263] 0 0
India
State/province [263] 0 0
Surat
Country [264] 0 0
Ireland
State/province [264] 0 0
Cork
Country [265] 0 0
Ireland
State/province [265] 0 0
Dublin
Country [266] 0 0
Ireland
State/province [266] 0 0
Galway
Country [267] 0 0
Ireland
State/province [267] 0 0
Waterford
Country [268] 0 0
Israel
State/province [268] 0 0
Afula
Country [269] 0 0
Israel
State/province [269] 0 0
Ashdod
Country [270] 0 0
Israel
State/province [270] 0 0
Beer Sheva
Country [271] 0 0
Israel
State/province [271] 0 0
Haifa
Country [272] 0 0
Israel
State/province [272] 0 0
Jerusalem
Country [273] 0 0
Israel
State/province [273] 0 0
Kfar Saba
Country [274] 0 0
Israel
State/province [274] 0 0
Nahariya
Country [275] 0 0
Israel
State/province [275] 0 0
Ramat Gan
Country [276] 0 0
Italy
State/province [276] 0 0
Bologna
Country [277] 0 0
Italy
State/province [277] 0 0
Brindisi
Country [278] 0 0
Italy
State/province [278] 0 0
Firenze
Country [279] 0 0
Italy
State/province [279] 0 0
Genoa
Country [280] 0 0
Italy
State/province [280] 0 0
Milano
Country [281] 0 0
Italy
State/province [281] 0 0
Milan
Country [282] 0 0
Italy
State/province [282] 0 0
Misterbianco
Country [283] 0 0
Italy
State/province [283] 0 0
Modena
Country [284] 0 0
Italy
State/province [284] 0 0
Monza
Country [285] 0 0
Italy
State/province [285] 0 0
Napoli
Country [286] 0 0
Italy
State/province [286] 0 0
Novara
Country [287] 0 0
Italy
State/province [287] 0 0
Padova
Country [288] 0 0
Italy
State/province [288] 0 0
Roma
Country [289] 0 0
Italy
State/province [289] 0 0
Rozzano
Country [290] 0 0
Italy
State/province [290] 0 0
Torino
Country [291] 0 0
Italy
State/province [291] 0 0
Trento
Country [292] 0 0
Japan
State/province [292] 0 0
Chiba-shi
Country [293] 0 0
Japan
State/province [293] 0 0
Fukuoka-shi
Country [294] 0 0
Japan
State/province [294] 0 0
Fukushima-shi
Country [295] 0 0
Japan
State/province [295] 0 0
Hirakata-shi
Country [296] 0 0
Japan
State/province [296] 0 0
Hiroshima-shi
Country [297] 0 0
Japan
State/province [297] 0 0
Iruma-Gun
Country [298] 0 0
Japan
State/province [298] 0 0
Isehara-shi
Country [299] 0 0
Japan
State/province [299] 0 0
Kagoshima-shi
Country [300] 0 0
Japan
State/province [300] 0 0
Kashiwa
Country [301] 0 0
Japan
State/province [301] 0 0
Koto-ku
Country [302] 0 0
Japan
State/province [302] 0 0
Kumamoto-shi
Country [303] 0 0
Japan
State/province [303] 0 0
Kurume-shi
Country [304] 0 0
Japan
State/province [304] 0 0
Kyoto-shi
Country [305] 0 0
Japan
State/province [305] 0 0
Matsuyama-shi
Country [306] 0 0
Japan
State/province [306] 0 0
Nagoya-shi
Country [307] 0 0
Japan
State/province [307] 0 0
Niigata-shi
Country [308] 0 0
Japan
State/province [308] 0 0
Osaka-shi
Country [309] 0 0
Japan
State/province [309] 0 0
Ota-shi
Country [310] 0 0
Japan
State/province [310] 0 0
Sapporo-shi
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Japan
State/province [311] 0 0
Sendai-shi
Country [312] 0 0
Japan
State/province [312] 0 0
Shinagawa-ku
Country [313] 0 0
Japan
State/province [313] 0 0
Suita-shi
Country [314] 0 0
Japan
State/province [314] 0 0
Sunto-gun
Country [315] 0 0
Japan
State/province [315] 0 0
Takasaki-shi
Country [316] 0 0
Japan
State/province [316] 0 0
Tsu-shi
Country [317] 0 0
Japan
State/province [317] 0 0
Yokohama-shi
Country [318] 0 0
Korea, Republic of
State/province [318] 0 0
Cheonan-si
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Korea, Republic of
State/province [319] 0 0
Daegu
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Korea, Republic of
State/province [320] 0 0
Goyang-si
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Korea, Republic of
State/province [321] 0 0
Seongnam-si
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Korea, Republic of
State/province [322] 0 0
Seoul
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Johor Bahru
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Malaysia
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Kota Bharu
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Malaysia
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Kuala Lumpur
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Malaysia
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Kuching
Country [327] 0 0
Malaysia
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Melaka
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Malaysia
State/province [328] 0 0
Pulau Pinang
Country [329] 0 0
Mexico
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Alc. Cuauhtémoc
Country [330] 0 0
Mexico
State/province [330] 0 0
Cancún
Country [331] 0 0
Mexico
State/province [331] 0 0
Colonia Lindavista
Country [332] 0 0
Mexico
State/province [332] 0 0
Mexico
Country [333] 0 0
Mexico
State/province [333] 0 0
Monterrey
Country [334] 0 0
Mexico
State/province [334] 0 0
San Luis Potosí
Country [335] 0 0
Mexico
State/province [335] 0 0
Tuxtla Gutiérrez
Country [336] 0 0
Mexico
State/province [336] 0 0
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Country [337] 0 0
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State/province [337] 0 0
Auckland
Country [338] 0 0
New Zealand
State/province [338] 0 0
Hamilton
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New Zealand
State/province [339] 0 0
Palmerston North
Country [340] 0 0
Peru
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Arequipa
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Peru
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Lima
Country [342] 0 0
Philippines
State/province [342] 0 0
Bacolod
Country [343] 0 0
Philippines
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Cebu City
Country [344] 0 0
Philippines
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Iloilo City
Country [345] 0 0
Philippines
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Quezon
Country [346] 0 0
Poland
State/province [346] 0 0
Biala Podlaska
Country [347] 0 0
Poland
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Bialystok
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
State/province [350] 0 0
Gdynia
Country [351] 0 0
Poland
State/province [351] 0 0
Grudziadz
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Poland
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Koszalin
Country [353] 0 0
Poland
State/province [353] 0 0
Kraków
Country [354] 0 0
Poland
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Lublin
Country [355] 0 0
Poland
State/province [355] 0 0
Opole
Country [356] 0 0
Poland
State/province [356] 0 0
Poznan
Country [357] 0 0
Poland
State/province [357] 0 0
Racibórz
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Poland
State/province [358] 0 0
Rzeszow
Country [359] 0 0
Poland
State/province [359] 0 0
Rzeszów
Country [360] 0 0
Poland
State/province [360] 0 0
Szczecin
Country [361] 0 0
Poland
State/province [361] 0 0
Tomaszów Mazowiecki
Country [362] 0 0
Poland
State/province [362] 0 0
Warszawa
Country [363] 0 0
Poland
State/province [363] 0 0
Wroclaw
Country [364] 0 0
Poland
State/province [364] 0 0
Lódz
Country [365] 0 0
Portugal
State/province [365] 0 0
Amadora
Country [366] 0 0
Portugal
State/province [366] 0 0
Lisboa
Country [367] 0 0
Portugal
State/province [367] 0 0
Porto
Country [368] 0 0
Portugal
State/province [368] 0 0
Viana do Castelo
Country [369] 0 0
Portugal
State/province [369] 0 0
Vila Nova de Gaia
Country [370] 0 0
Puerto Rico
State/province [370] 0 0
Rio Piedras
Country [371] 0 0
Romania
State/province [371] 0 0
Bucuresti
Country [372] 0 0
Romania
State/province [372] 0 0
Cluj-Napoca
Country [373] 0 0
Romania
State/province [373] 0 0
Craiova
Country [374] 0 0
Romania
State/province [374] 0 0
Iasi
Country [375] 0 0
Romania
State/province [375] 0 0
Oradea
Country [376] 0 0
Romania
State/province [376] 0 0
Otopeni
Country [377] 0 0
Romania
State/province [377] 0 0
Ovidiu
Country [378] 0 0
Romania
State/province [378] 0 0
Pitesti
Country [379] 0 0
Romania
State/province [379] 0 0
Sibiu
Country [380] 0 0
Romania
State/province [380] 0 0
Timisoara
Country [381] 0 0
Saudi Arabia
State/province [381] 0 0
Riyadh/MENA
Country [382] 0 0
Serbia
State/province [382] 0 0
Belgrade
Country [383] 0 0
Serbia
State/province [383] 0 0
Belgrad
Country [384] 0 0
Serbia
State/province [384] 0 0
Beograd
Country [385] 0 0
Serbia
State/province [385] 0 0
Kragujevac
Country [386] 0 0
Serbia
State/province [386] 0 0
Nis
Country [387] 0 0
Serbia
State/province [387] 0 0
Novi Sad
Country [388] 0 0
Serbia
State/province [388] 0 0
Valjevo
Country [389] 0 0
Serbia
State/province [389] 0 0
Zrenjanin
Country [390] 0 0
South Africa
State/province [390] 0 0
Bloemfontein
Country [391] 0 0
South Africa
State/province [391] 0 0
George
Country [392] 0 0
South Africa
State/province [392] 0 0
Johannesburg
Country [393] 0 0
South Africa
State/province [393] 0 0
Pietermaritzburg
Country [394] 0 0
South Africa
State/province [394] 0 0
Port Elizabeth
Country [395] 0 0
Spain
State/province [395] 0 0
A Coruña
Country [396] 0 0
Spain
State/province [396] 0 0
Albacete
Country [397] 0 0
Spain
State/province [397] 0 0
Alicante
Country [398] 0 0
Spain
State/province [398] 0 0
Badalona
Country [399] 0 0
Spain
State/province [399] 0 0
Barakaldo
Country [400] 0 0
Spain
State/province [400] 0 0
Barcelona
Country [401] 0 0
Spain
State/province [401] 0 0
Burgos
Country [402] 0 0
Spain
State/province [402] 0 0
Caceres
Country [403] 0 0
Spain
State/province [403] 0 0
Castello de la Plana
Country [404] 0 0
Spain
State/province [404] 0 0
Cordoba
Country [405] 0 0
Spain
State/province [405] 0 0
El Palmar
Country [406] 0 0
Spain
State/province [406] 0 0
Elche(Alicante)
Country [407] 0 0
Spain
State/province [407] 0 0
Fuenlabrada
Country [408] 0 0
Spain
State/province [408] 0 0
Granada
Country [409] 0 0
Spain
State/province [409] 0 0
Jerez de la Frontera
Country [410] 0 0
Spain
State/province [410] 0 0
La Coruña
Country [411] 0 0
Spain
State/province [411] 0 0
La Laguna (Tenerife)
Country [412] 0 0
Spain
State/province [412] 0 0
Leon
Country [413] 0 0
Spain
State/province [413] 0 0
Lérida
Country [414] 0 0
Spain
State/province [414] 0 0
Madrid
Country [415] 0 0
Spain
State/province [415] 0 0
Malaga
Country [416] 0 0
Spain
State/province [416] 0 0
Manresa
Country [417] 0 0
Spain
State/province [417] 0 0
Murcia
Country [418] 0 0
Spain
State/province [418] 0 0
Málaga
Country [419] 0 0
Spain
State/province [419] 0 0
Palma de Mallorca
Country [420] 0 0
Spain
State/province [420] 0 0
Reus,Tarragona
Country [421] 0 0
Spain
State/province [421] 0 0
Sabadell
Country [422] 0 0
Spain
State/province [422] 0 0
Salamanca
Country [423] 0 0
Spain
State/province [423] 0 0
San Sebastian
Country [424] 0 0
Spain
State/province [424] 0 0
Sant Joan Despí
Country [425] 0 0
Spain
State/province [425] 0 0
Sevilla
Country [426] 0 0
Spain
State/province [426] 0 0
Toledo
Country [427] 0 0
Spain
State/province [427] 0 0
Valencia
Country [428] 0 0
Spain
State/province [428] 0 0
Vigo
Country [429] 0 0
Spain
State/province [429] 0 0
Zaragoza
Country [430] 0 0
Switzerland
State/province [430] 0 0
Baden
Country [431] 0 0
Switzerland
State/province [431] 0 0
Basel
Country [432] 0 0
Switzerland
State/province [432] 0 0
Bellinzona
Country [433] 0 0
Switzerland
State/province [433] 0 0
Chur
Country [434] 0 0
Switzerland
State/province [434] 0 0
Frauenfeld
Country [435] 0 0
Switzerland
State/province [435] 0 0
La Chaux-De-Fonds
Country [436] 0 0
Switzerland
State/province [436] 0 0
Lausanne
Country [437] 0 0
Switzerland
State/province [437] 0 0
Luzern
Country [438] 0 0
Switzerland
State/province [438] 0 0
St. Gallen
Country [439] 0 0
Switzerland
State/province [439] 0 0
Winterthur
Country [440] 0 0
Switzerland
State/province [440] 0 0
Zürich
Country [441] 0 0
Taiwan
State/province [441] 0 0
Hsinchu
Country [442] 0 0
Taiwan
State/province [442] 0 0
Kaohsiung
Country [443] 0 0
Taiwan
State/province [443] 0 0
Taichung
Country [444] 0 0
Taiwan
State/province [444] 0 0
Tainan
Country [445] 0 0
Taiwan
State/province [445] 0 0
Taipei
Country [446] 0 0
Taiwan
State/province [446] 0 0
Yong Kang City
Country [447] 0 0
Thailand
State/province [447] 0 0
Bangkok
Country [448] 0 0
Thailand
State/province [448] 0 0
Hat Yai
Country [449] 0 0
Thailand
State/province [449] 0 0
Khon Kaen
Country [450] 0 0
Turkey
State/province [450] 0 0
Ankara
Country [451] 0 0
Turkey
State/province [451] 0 0
Antalya
Country [452] 0 0
Turkey
State/province [452] 0 0
Bursa
Country [453] 0 0
Turkey
State/province [453] 0 0
Cigli
Country [454] 0 0
Turkey
State/province [454] 0 0
Edirne
Country [455] 0 0
Turkey
State/province [455] 0 0
Istanbul
Country [456] 0 0
Turkey
State/province [456] 0 0
Karsiyaka
Country [457] 0 0
Turkey
State/province [457] 0 0
Malatya
Country [458] 0 0
Turkey
State/province [458] 0 0
Samsun
Country [459] 0 0
Turkey
State/province [459] 0 0
Çankaya
Country [460] 0 0
United Arab Emirates
State/province [460] 0 0
Abu Dhabi
Country [461] 0 0
United Arab Emirates
State/province [461] 0 0
Al Ain
Country [462] 0 0
United Arab Emirates
State/province [462] 0 0
Dubai
Country [463] 0 0
United Kingdom
State/province [463] 0 0
Aberdeen
Country [464] 0 0
United Kingdom
State/province [464] 0 0
Bath
Country [465] 0 0
United Kingdom
State/province [465] 0 0
Brighton
Country [466] 0 0
United Kingdom
State/province [466] 0 0
Cambridge
Country [467] 0 0
United Kingdom
State/province [467] 0 0
Guilford
Country [468] 0 0
United Kingdom
State/province [468] 0 0
Ipswich
Country [469] 0 0
United Kingdom
State/province [469] 0 0
Lancaster
Country [470] 0 0
United Kingdom
State/province [470] 0 0
Leeds
Country [471] 0 0
United Kingdom
State/province [471] 0 0
Leicester
Country [472] 0 0
United Kingdom
State/province [472] 0 0
Liverpool
Country [473] 0 0
United Kingdom
State/province [473] 0 0
London
Country [474] 0 0
United Kingdom
State/province [474] 0 0
Manchester
Country [475] 0 0
United Kingdom
State/province [475] 0 0
Northampton
Country [476] 0 0
United Kingdom
State/province [476] 0 0
Oxford
Country [477] 0 0
United Kingdom
State/province [477] 0 0
Reading
Country [478] 0 0
United Kingdom
State/province [478] 0 0
Shrewsbury
Country [479] 0 0
United Kingdom
State/province [479] 0 0
Stockton
Country [480] 0 0
United Kingdom
State/province [480] 0 0
Sutton In Ashfield
Country [481] 0 0
United Kingdom
State/province [481] 0 0
Sutton
Country [482] 0 0
United Kingdom
State/province [482] 0 0
Taunton
Country [483] 0 0
United Kingdom
State/province [483] 0 0
Warwick
Country [484] 0 0
United Kingdom
State/province [484] 0 0
Whitchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Austrian Breast and Colorectal Cancer Study Group (ABCSG)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05952557
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05952557