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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05774951




Registration number
NCT05774951
Ethics application status
Date submitted
16/02/2023
Date registered
20/03/2023

Titles & IDs
Public title
A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
Scientific title
CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence
Secondary ID [1] 0 0
2022-501024-20-00
Secondary ID [2] 0 0
D8531C00002
Universal Trial Number (UTN)
Trial acronym
CAMBRIA-1
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

Active comparator: Arm A: standard endocrine therapy of investigator´s choice - Continue standard endocrine therapy of investigator's choice (aromatase inhibitors \[AI; exemestane, letrozole, anastrozole\] or tamoxifen)

Experimental: Arm B: camizestrant - Camizestrant


Treatment: Drugs: Camizestrant
Camizestrant. Experimental. Administered orally

Treatment: Drugs: Tamoxifen
Tamoxifen. Comparator. Administered per local approved label

Treatment: Drugs: Anastrozole
Anastrozole. Comparator. Administered per local approved label

Treatment: Drugs: Letrozole
Letrozole. Comparator. Administered per local approved label

Treatment: Drugs: Exemestane
Exemestane. Comparator. Administered per local approved label
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 10 years
Secondary outcome [1] 0 0
Invasive disease-free survival (IDFS)
Timepoint [1] 0 0
Up to 10 years
Secondary outcome [2] 0 0
Distant relapse-free survival (DRFS)
Timepoint [2] 0 0
Up to 10 years
Secondary outcome [3] 0 0
Overall survival (OS)
Timepoint [3] 0 0
Up to 10 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 5 years)
Secondary outcome [5] 0 0
Absolute and percent change from baseline in Clinical Laboratory Parameters
Timepoint [5] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [6] 0 0
Absolute and percent change from baseline in Vital Sign Parameters
Timepoint [6] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [7] 0 0
Number of participants with abnormal physical examinations
Timepoint [7] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [8] 0 0
Change from baseline of arthralgia as measured by the EORTC-IL-194 (European Organisation for Research and Treatment of Cancer) item 10. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
Timepoint [8] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [9] 0 0
Change from baseline of hot flush as measured by the EORTC-IL-194 item 4. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
Timepoint [9] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [10] 0 0
Change from baseline of vaginal dryness as measured by the EORTC-IL-194 item 15. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
Timepoint [10] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [11] 0 0
Proportion of patients experiencing each level of symptomatic AEs of arthralgia as measured by the EORTC-IL-194 item 10. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
Timepoint [11] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [12] 0 0
Proportion of patients experiencing each level of symptomatic AEs of hot flush as measured by the EORTC-IL-194 item 4. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
Timepoint [12] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [13] 0 0
Proportion of patients experiencing each level of symptomatic AEs of vaginal dryness as measured by the EORTC-IL-194 item 15. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
Timepoint [13] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [14] 0 0
Change from baseline and TTD (time to deterioration ) of health-related QoL (quality of life) as measured by the 2 global QoL items from the EORTC-QLQ-C30 items 11 and 12. EORTC-QLQ-C30 uses 0 - 4 scale (higher score is worse)
Timepoint [14] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [15] 0 0
Pharmacokinetics (PK)
Timepoint [15] 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 high or intermediate risk of recurrence, based on clinical-pathological risk features, as defined in the protocol.
* Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy
* Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/- CDK4/6 inhibitor)
* Eastern Cooperative Oncology Group (ECOG) performance status of = 1
* Adequate organ and marrow function
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Inoperable locally advanced or metastatic breast cancer
* Pathological complete response following treatment with neoadjuvant therapy
* History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered at very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation
* Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance
* Known LVEF <50% with heart failure NYHA Grade =2.
* Mean resting QTcF interval >480 ms at screening
* Concurrent exogenous 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
31/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/05/2036
Actual
Sample size
Target
4300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Birtinya
Recruitment hospital [2] 0 0
Research Site - Brighton
Recruitment hospital [3] 0 0
Research Site - Concord
Recruitment hospital [4] 0 0
Research Site - Nedlands
Recruitment hospital [5] 0 0
Research Site - Randwick
Recruitment hospital [6] 0 0
Research Site - Tweed Heads
Recruitment hospital [7] 0 0
Research Site - Waratah
Recruitment hospital [8] 0 0
Research Site - Wendouree
Recruitment postcode(s) [1] 0 0
4575 - Birtinya
Recruitment postcode(s) [2] 0 0
3186 - Brighton
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment postcode(s) [5] 0 0
2031 - Randwick
Recruitment postcode(s) [6] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [7] 0 0
2298 - Waratah
Recruitment postcode(s) [8] 0 0
3355 - Wendouree
Recruitment outside Australia
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United States of America
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Alabama
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Alaska
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Country [188] 0 0
France
State/province [188] 0 0
Lorient cedex
Country [189] 0 0
France
State/province [189] 0 0
Lyon
Country [190] 0 0
France
State/province [190] 0 0
Marseille
Country [191] 0 0
France
State/province [191] 0 0
Metz Cedex 03
Country [192] 0 0
France
State/province [192] 0 0
Montpellier
Country [193] 0 0
France
State/province [193] 0 0
Nantes
Country [194] 0 0
France
State/province [194] 0 0
Nimes
Country [195] 0 0
France
State/province [195] 0 0
Paris
Country [196] 0 0
France
State/province [196] 0 0
Pierre Benite
Country [197] 0 0
France
State/province [197] 0 0
Plerin SUR MER
Country [198] 0 0
France
State/province [198] 0 0
Poitiers
Country [199] 0 0
France
State/province [199] 0 0
Quimper Cedex
Country [200] 0 0
France
State/province [200] 0 0
Rennes
Country [201] 0 0
France
State/province [201] 0 0
Saint Cloud
Country [202] 0 0
France
State/province [202] 0 0
Saint Herblain Cedex
Country [203] 0 0
France
State/province [203] 0 0
St-Priest-en-Jarez
Country [204] 0 0
France
State/province [204] 0 0
Suresnes Cedex
Country [205] 0 0
France
State/province [205] 0 0
Toulouse
Country [206] 0 0
France
State/province [206] 0 0
Tours CEDEX
Country [207] 0 0
France
State/province [207] 0 0
Villejuif
Country [208] 0 0
Georgia
State/province [208] 0 0
Batumi
Country [209] 0 0
Georgia
State/province [209] 0 0
Tbilisi
Country [210] 0 0
Germany
State/province [210] 0 0
Aachen
Country [211] 0 0
Germany
State/province [211] 0 0
Augsburg
Country [212] 0 0
Germany
State/province [212] 0 0
Bayreuth
Country [213] 0 0
Germany
State/province [213] 0 0
Berlin
Country [214] 0 0
Germany
State/province [214] 0 0
Bonn
Country [215] 0 0
Germany
State/province [215] 0 0
Deggendorf
Country [216] 0 0
Germany
State/province [216] 0 0
Dessau-Rosslau
Country [217] 0 0
Germany
State/province [217] 0 0
Dresden
Country [218] 0 0
Germany
State/province [218] 0 0
Düsseldorf
Country [219] 0 0
Germany
State/province [219] 0 0
Eggenfelden
Country [220] 0 0
Germany
State/province [220] 0 0
Esslingen
Country [221] 0 0
Germany
State/province [221] 0 0
Georgsmarienhuette
Country [222] 0 0
Germany
State/province [222] 0 0
Guetersloh
Country [223] 0 0
Germany
State/province [223] 0 0
Hamburg
Country [224] 0 0
Germany
State/province [224] 0 0
Heidelberg
Country [225] 0 0
Germany
State/province [225] 0 0
Kiel
Country [226] 0 0
Germany
State/province [226] 0 0
Landshut
Country [227] 0 0
Germany
State/province [227] 0 0
Luebeck
Country [228] 0 0
Germany
State/province [228] 0 0
Mainz
Country [229] 0 0
Germany
State/province [229] 0 0
Memmingen
Country [230] 0 0
Germany
State/province [230] 0 0
München
Country [231] 0 0
Germany
State/province [231] 0 0
Ravensburg
Country [232] 0 0
Germany
State/province [232] 0 0
Rüsselsheim am Main
Country [233] 0 0
Germany
State/province [233] 0 0
Stralsund
Country [234] 0 0
Germany
State/province [234] 0 0
Torgau
Country [235] 0 0
Germany
State/province [235] 0 0
Trier
Country [236] 0 0
Germany
State/province [236] 0 0
Ulm
Country [237] 0 0
Germany
State/province [237] 0 0
Velbert
Country [238] 0 0
Germany
State/province [238] 0 0
Wiesbaden
Country [239] 0 0
Germany
State/province [239] 0 0
Worms
Country [240] 0 0
Germany
State/province [240] 0 0
Wuppertal
Country [241] 0 0
Greece
State/province [241] 0 0
Athens
Country [242] 0 0
Greece
State/province [242] 0 0
Chaidari
Country [243] 0 0
Greece
State/province [243] 0 0
Heraklion
Country [244] 0 0
Greece
State/province [244] 0 0
Ioannina
Country [245] 0 0
Greece
State/province [245] 0 0
Rio
Country [246] 0 0
Greece
State/province [246] 0 0
Thessaloniki
Country [247] 0 0
Hungary
State/province [247] 0 0
Budapest
Country [248] 0 0
Hungary
State/province [248] 0 0
Debrecen
Country [249] 0 0
Hungary
State/province [249] 0 0
Gyula
Country [250] 0 0
Hungary
State/province [250] 0 0
Gyor
Country [251] 0 0
Hungary
State/province [251] 0 0
Kaposvár
Country [252] 0 0
Hungary
State/province [252] 0 0
Miskolc
Country [253] 0 0
Hungary
State/province [253] 0 0
Nyíregyháza
Country [254] 0 0
Hungary
State/province [254] 0 0
Szekszárd
Country [255] 0 0
Hungary
State/province [255] 0 0
Szolnok
Country [256] 0 0
India
State/province [256] 0 0
Bangalore
Country [257] 0 0
India
State/province [257] 0 0
Belagavi
Country [258] 0 0
India
State/province [258] 0 0
Bhubaneswar
Country [259] 0 0
India
State/province [259] 0 0
Hubli
Country [260] 0 0
India
State/province [260] 0 0
Hyderabad
Country [261] 0 0
India
State/province [261] 0 0
Jaipur
Country [262] 0 0
India
State/province [262] 0 0
Kolkata
Country [263] 0 0
India
State/province [263] 0 0
Mumbai
Country [264] 0 0
India
State/province [264] 0 0
Nagpur
Country [265] 0 0
India
State/province [265] 0 0
Nashik
Country [266] 0 0
India
State/province [266] 0 0
New Delhi
Country [267] 0 0
India
State/province [267] 0 0
Pune
Country [268] 0 0
India
State/province [268] 0 0
Thane
Country [269] 0 0
India
State/province [269] 0 0
Visakhapatnam
Country [270] 0 0
India
State/province [270] 0 0
West Bengal
Country [271] 0 0
Israel
State/province [271] 0 0
Afula
Country [272] 0 0
Israel
State/province [272] 0 0
Ashdod
Country [273] 0 0
Israel
State/province [273] 0 0
Haifa
Country [274] 0 0
Israel
State/province [274] 0 0
Jerusalem
Country [275] 0 0
Israel
State/province [275] 0 0
Kfar-Saba
Country [276] 0 0
Israel
State/province [276] 0 0
Nahariya
Country [277] 0 0
Israel
State/province [277] 0 0
Ramat Gan
Country [278] 0 0
Israel
State/province [278] 0 0
Rehovot
Country [279] 0 0
Israel
State/province [279] 0 0
Tel Aviv
Country [280] 0 0
Italy
State/province [280] 0 0
Bari
Country [281] 0 0
Italy
State/province [281] 0 0
Catania
Country [282] 0 0
Italy
State/province [282] 0 0
Catanzaro
Country [283] 0 0
Italy
State/province [283] 0 0
Firenze
Country [284] 0 0
Italy
State/province [284] 0 0
Genova
Country [285] 0 0
Italy
State/province [285] 0 0
Grosseto
Country [286] 0 0
Italy
State/province [286] 0 0
Milano
Country [287] 0 0
Italy
State/province [287] 0 0
Milan
Country [288] 0 0
Italy
State/province [288] 0 0
Modena
Country [289] 0 0
Italy
State/province [289] 0 0
Napoli
Country [290] 0 0
Italy
State/province [290] 0 0
Pisa
Country [291] 0 0
Italy
State/province [291] 0 0
Reggio Emilia
Country [292] 0 0
Italy
State/province [292] 0 0
Roma
Country [293] 0 0
Italy
State/province [293] 0 0
Rozzano
Country [294] 0 0
Italy
State/province [294] 0 0
Turin
Country [295] 0 0
Japan
State/province [295] 0 0
Chiba-shi
Country [296] 0 0
Japan
State/province [296] 0 0
Fukuoka-shi
Country [297] 0 0
Japan
State/province [297] 0 0
Fukushima-shi
Country [298] 0 0
Japan
State/province [298] 0 0
Hidaka-shi
Country [299] 0 0
Japan
State/province [299] 0 0
Hirakata-shi
Country [300] 0 0
Japan
State/province [300] 0 0
Hiroshima-shi
Country [301] 0 0
Japan
State/province [301] 0 0
Isehara-shi
Country [302] 0 0
Japan
State/province [302] 0 0
Kagoshima-shi
Country [303] 0 0
Japan
State/province [303] 0 0
Kashiwa
Country [304] 0 0
Japan
State/province [304] 0 0
Kitaadachi-gun
Country [305] 0 0
Japan
State/province [305] 0 0
Koto-ku
Country [306] 0 0
Japan
State/province [306] 0 0
Kumamoto-shi
Country [307] 0 0
Japan
State/province [307] 0 0
Kurume-shi
Country [308] 0 0
Japan
State/province [308] 0 0
Kyoto-shi
Country [309] 0 0
Japan
State/province [309] 0 0
Matsuyama-shi
Country [310] 0 0
Japan
State/province [310] 0 0
Nagoya-shi
Country [311] 0 0
Japan
State/province [311] 0 0
Niigata-shi
Country [312] 0 0
Japan
State/province [312] 0 0
Osaka-shi
Country [313] 0 0
Japan
State/province [313] 0 0
Ota-shi
Country [314] 0 0
Japan
State/province [314] 0 0
Sagamihara-shi
Country [315] 0 0
Japan
State/province [315] 0 0
Sapporo
Country [316] 0 0
Japan
State/province [316] 0 0
Sendai-shi
Country [317] 0 0
Japan
State/province [317] 0 0
Suita-shi
Country [318] 0 0
Japan
State/province [318] 0 0
Sunto-gun
Country [319] 0 0
Japan
State/province [319] 0 0
Takasaki-shi
Country [320] 0 0
Japan
State/province [320] 0 0
Tsu-shi
Country [321] 0 0
Japan
State/province [321] 0 0
Yokohama-shi
Country [322] 0 0
Korea, Republic of
State/province [322] 0 0
Busan
Country [323] 0 0
Korea, Republic of
State/province [323] 0 0
Daegu
Country [324] 0 0
Korea, Republic of
State/province [324] 0 0
Donggu
Country [325] 0 0
Korea, Republic of
State/province [325] 0 0
Goyang-si
Country [326] 0 0
Korea, Republic of
State/province [326] 0 0
Jeonnam
Country [327] 0 0
Korea, Republic of
State/province [327] 0 0
Seongbuk-Gu
Country [328] 0 0
Korea, Republic of
State/province [328] 0 0
Seoul
Country [329] 0 0
Malaysia
State/province [329] 0 0
George Town
Country [330] 0 0
Malaysia
State/province [330] 0 0
Georgetown
Country [331] 0 0
Malaysia
State/province [331] 0 0
Johor Bahru
Country [332] 0 0
Malaysia
State/province [332] 0 0
Kota Bharu
Country [333] 0 0
Malaysia
State/province [333] 0 0
Kuala Lumpur
Country [334] 0 0
Malaysia
State/province [334] 0 0
Kuching
Country [335] 0 0
Malaysia
State/province [335] 0 0
Melaka
Country [336] 0 0
Malaysia
State/province [336] 0 0
Sabah
Country [337] 0 0
Mexico
State/province [337] 0 0
Aguascalientes
Country [338] 0 0
Mexico
State/province [338] 0 0
Alc. Cuauhtémoc
Country [339] 0 0
Mexico
State/province [339] 0 0
Colonia Lindavista
Country [340] 0 0
Mexico
State/province [340] 0 0
Mexico City
Country [341] 0 0
Mexico
State/province [341] 0 0
Mexico
Country [342] 0 0
Mexico
State/province [342] 0 0
Monterrey
Country [343] 0 0
Mexico
State/province [343] 0 0
Mérida
Country [344] 0 0
Mexico
State/province [344] 0 0
San Luis Potosí
Country [345] 0 0
Mexico
State/province [345] 0 0
Toluca
Country [346] 0 0
Mexico
State/province [346] 0 0
Veracruz
Country [347] 0 0
Netherlands
State/province [347] 0 0
Dirksland
Country [348] 0 0
Netherlands
State/province [348] 0 0
Geleen
Country [349] 0 0
Netherlands
State/province [349] 0 0
Groningen
Country [350] 0 0
Netherlands
State/province [350] 0 0
Hoofddorp
Country [351] 0 0
Netherlands
State/province [351] 0 0
Rotterdam
Country [352] 0 0
Peru
State/province [352] 0 0
Arequipa
Country [353] 0 0
Peru
State/province [353] 0 0
Callao
Country [354] 0 0
Peru
State/province [354] 0 0
La Libertad
Country [355] 0 0
Peru
State/province [355] 0 0
Lima
Country [356] 0 0
Peru
State/province [356] 0 0
Trujillo
Country [357] 0 0
Philippines
State/province [357] 0 0
Bacolod
Country [358] 0 0
Philippines
State/province [358] 0 0
Cebu
Country [359] 0 0
Philippines
State/province [359] 0 0
Iloilo city
Country [360] 0 0
Philippines
State/province [360] 0 0
Manila
Country [361] 0 0
Philippines
State/province [361] 0 0
Quezon City
Country [362] 0 0
Poland
State/province [362] 0 0
Bialystok
Country [363] 0 0
Poland
State/province [363] 0 0
Grudziadz
Country [364] 0 0
Poland
State/province [364] 0 0
Koszalin
Country [365] 0 0
Poland
State/province [365] 0 0
Lublin
Country [366] 0 0
Poland
State/province [366] 0 0
Opole
Country [367] 0 0
Poland
State/province [367] 0 0
Poznan
Country [368] 0 0
Poland
State/province [368] 0 0
Racibórz
Country [369] 0 0
Poland
State/province [369] 0 0
Rzeszów
Country [370] 0 0
Poland
State/province [370] 0 0
Warszawa
Country [371] 0 0
Poland
State/province [371] 0 0
Wieliszew
Country [372] 0 0
Poland
State/province [372] 0 0
Lódz
Country [373] 0 0
Portugal
State/province [373] 0 0
Amadora
Country [374] 0 0
Portugal
State/province [374] 0 0
Braga
Country [375] 0 0
Portugal
State/province [375] 0 0
Guimarães
Country [376] 0 0
Portugal
State/province [376] 0 0
Lisboa
Country [377] 0 0
Portugal
State/province [377] 0 0
Matosinhos
Country [378] 0 0
Portugal
State/province [378] 0 0
Porto
Country [379] 0 0
Portugal
State/province [379] 0 0
Vila Nova de Gaia
Country [380] 0 0
Romania
State/province [380] 0 0
Baia Mare
Country [381] 0 0
Romania
State/province [381] 0 0
Brasov
Country [382] 0 0
Romania
State/province [382] 0 0
Cluj Napoca
Country [383] 0 0
Romania
State/province [383] 0 0
Cluj-Napoca
Country [384] 0 0
Romania
State/province [384] 0 0
Constanta
Country [385] 0 0
Romania
State/province [385] 0 0
Craiova
Country [386] 0 0
Romania
State/province [386] 0 0
Floresti
Country [387] 0 0
Romania
State/province [387] 0 0
Iasi
Country [388] 0 0
Romania
State/province [388] 0 0
Oradea
Country [389] 0 0
Romania
State/province [389] 0 0
Pitesti
Country [390] 0 0
Romania
State/province [390] 0 0
Sibiu
Country [391] 0 0
Romania
State/province [391] 0 0
Timisoara
Country [392] 0 0
Serbia
State/province [392] 0 0
Belgrade
Country [393] 0 0
Serbia
State/province [393] 0 0
Belgrad
Country [394] 0 0
Serbia
State/province [394] 0 0
Beograd
Country [395] 0 0
Serbia
State/province [395] 0 0
Kragujevac
Country [396] 0 0
Serbia
State/province [396] 0 0
Nis
Country [397] 0 0
Serbia
State/province [397] 0 0
Sremska Kamenica
Country [398] 0 0
Serbia
State/province [398] 0 0
Valjevo
Country [399] 0 0
Serbia
State/province [399] 0 0
Zrenjanin
Country [400] 0 0
Singapore
State/province [400] 0 0
Singapore
Country [401] 0 0
South Africa
State/province [401] 0 0
Amanzimtoti
Country [402] 0 0
South Africa
State/province [402] 0 0
Bloemfontein
Country [403] 0 0
South Africa
State/province [403] 0 0
George
Country [404] 0 0
South Africa
State/province [404] 0 0
Johannesburg
Country [405] 0 0
South Africa
State/province [405] 0 0
Pietermaritzburg
Country [406] 0 0
South Africa
State/province [406] 0 0
Pretoria
Country [407] 0 0
South Africa
State/province [407] 0 0
Soweto
Country [408] 0 0
Spain
State/province [408] 0 0
A Coruña
Country [409] 0 0
Spain
State/province [409] 0 0
Albacete
Country [410] 0 0
Spain
State/province [410] 0 0
Alcoy
Country [411] 0 0
Spain
State/province [411] 0 0
Alicant
Country [412] 0 0
Spain
State/province [412] 0 0
Alzira
Country [413] 0 0
Spain
State/province [413] 0 0
Badajoz
Country [414] 0 0
Spain
State/province [414] 0 0
Badalona
Country [415] 0 0
Spain
State/province [415] 0 0
Barakaldo
Country [416] 0 0
Spain
State/province [416] 0 0
Barcelona
Country [417] 0 0
Spain
State/province [417] 0 0
Cáceres
Country [418] 0 0
Spain
State/province [418] 0 0
Elche(Alicante)
Country [419] 0 0
Spain
State/province [419] 0 0
Galdakao
Country [420] 0 0
Spain
State/province [420] 0 0
Gerona
Country [421] 0 0
Spain
State/province [421] 0 0
Granada
Country [422] 0 0
Spain
State/province [422] 0 0
Jerez De La Frontera (Cádiz)
Country [423] 0 0
Spain
State/province [423] 0 0
L'Hospitalet de Llobregat
Country [424] 0 0
Spain
State/province [424] 0 0
Leganés
Country [425] 0 0
Spain
State/province [425] 0 0
Lérida
Country [426] 0 0
Spain
State/province [426] 0 0
Madrid
Country [427] 0 0
Spain
State/province [427] 0 0
Majadahonda
Country [428] 0 0
Spain
State/province [428] 0 0
Manresa
Country [429] 0 0
Spain
State/province [429] 0 0
Murcia
Country [430] 0 0
Spain
State/province [430] 0 0
Oviedo
Country [431] 0 0
Spain
State/province [431] 0 0
Parla
Country [432] 0 0
Spain
State/province [432] 0 0
Puerto De Sagunto
Country [433] 0 0
Spain
State/province [433] 0 0
Reus,Tarragona
Country [434] 0 0
Spain
State/province [434] 0 0
Salamanca
Country [435] 0 0
Spain
State/province [435] 0 0
San Juan de Alicante
Country [436] 0 0
Spain
State/province [436] 0 0
San Sebastián
Country [437] 0 0
Spain
State/province [437] 0 0
Santander
Country [438] 0 0
Spain
State/province [438] 0 0
Sevilla
Country [439] 0 0
Spain
State/province [439] 0 0
Teruel
Country [440] 0 0
Spain
State/province [440] 0 0
Toledo
Country [441] 0 0
Spain
State/province [441] 0 0
Valencia
Country [442] 0 0
Taiwan
State/province [442] 0 0
Hsinchu
Country [443] 0 0
Taiwan
State/province [443] 0 0
Kaohsiung
Country [444] 0 0
Taiwan
State/province [444] 0 0
Taichung
Country [445] 0 0
Taiwan
State/province [445] 0 0
Tainan City
Country [446] 0 0
Taiwan
State/province [446] 0 0
Tainan
Country [447] 0 0
Taiwan
State/province [447] 0 0
Taipei City
Country [448] 0 0
Taiwan
State/province [448] 0 0
Taipei
Country [449] 0 0
Thailand
State/province [449] 0 0
Bangkok
Country [450] 0 0
Thailand
State/province [450] 0 0
Khon Kaen
Country [451] 0 0
Thailand
State/province [451] 0 0
Phisanulok
Country [452] 0 0
Thailand
State/province [452] 0 0
Phitsanulok
Country [453] 0 0
Thailand
State/province [453] 0 0
Rachathewi
Country [454] 0 0
Thailand
State/province [454] 0 0
Songkla
Country [455] 0 0
Turkey
State/province [455] 0 0
Ankara
Country [456] 0 0
Turkey
State/province [456] 0 0
Aydin
Country [457] 0 0
Turkey
State/province [457] 0 0
Bursa
Country [458] 0 0
Turkey
State/province [458] 0 0
Dinar
Country [459] 0 0
Turkey
State/province [459] 0 0
Istambul
Country [460] 0 0
Turkey
State/province [460] 0 0
Istanbul
Country [461] 0 0
Turkey
State/province [461] 0 0
Izmir
Country [462] 0 0
Turkey
State/province [462] 0 0
Samsun
Country [463] 0 0
United Kingdom
State/province [463] 0 0
Brighton
Country [464] 0 0
United Kingdom
State/province [464] 0 0
Burton-on-Trent
Country [465] 0 0
United Kingdom
State/province [465] 0 0
Cambridge
Country [466] 0 0
United Kingdom
State/province [466] 0 0
Derby
Country [467] 0 0
United Kingdom
State/province [467] 0 0
Edinburgh
Country [468] 0 0
United Kingdom
State/province [468] 0 0
Guildford
Country [469] 0 0
United Kingdom
State/province [469] 0 0
Ipswich
Country [470] 0 0
United Kingdom
State/province [470] 0 0
Keighley
Country [471] 0 0
United Kingdom
State/province [471] 0 0
London
Country [472] 0 0
United Kingdom
State/province [472] 0 0
Manchester
Country [473] 0 0
United Kingdom
State/province [473] 0 0
Oxford
Country [474] 0 0
United Kingdom
State/province [474] 0 0
Peterborough
Country [475] 0 0
United Kingdom
State/province [475] 0 0
Stoke on Trent
Country [476] 0 0
United Kingdom
State/province [476] 0 0
Sutton
Country [477] 0 0
Vietnam
State/province [477] 0 0
Hanoi
Country [478] 0 0
Vietnam
State/province [478] 0 0
Ho Chi Minh city
Country [479] 0 0
Vietnam
State/province [479] 0 0
Ho Chi Minh
Country [480] 0 0
Vietnam
State/province [480] 0 0
Hue

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
information.center@astrazeneca.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
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
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05774951