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
Status: Recruiting
Location: See all (716) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 130
Healthy Volunteers: f
View:
• 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
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Research Site
NOT_YET_RECRUITING
Wiesbaden
Research Site
ACTIVE_NOT_RECRUITING
Wiesbaden
Research Site
ACTIVE_NOT_RECRUITING
Worms
Research Site
ACTIVE_NOT_RECRUITING
Wuppertal
Greece
Research Site
ACTIVE_NOT_RECRUITING
Athens
Research Site
ACTIVE_NOT_RECRUITING
Athens
Research Site
ACTIVE_NOT_RECRUITING
Athens
Research Site
ACTIVE_NOT_RECRUITING
Chaïdári
Research Site
ACTIVE_NOT_RECRUITING
Heraklion
Research Site
ACTIVE_NOT_RECRUITING
Ioannina
Research Site
ACTIVE_NOT_RECRUITING
Rio
Research Site
ACTIVE_NOT_RECRUITING
Thessaloniki
Research Site
NOT_YET_RECRUITING
Thessaloniki
Research Site
ACTIVE_NOT_RECRUITING
Thessaloniki
Research Site
ACTIVE_NOT_RECRUITING
Thessaloniki
Hungary
Research Site
ACTIVE_NOT_RECRUITING
Budapest
Research Site
ACTIVE_NOT_RECRUITING
Budapest
Research Site
ACTIVE_NOT_RECRUITING
Budapest
Research Site
WITHDRAWN
Budapest
Research Site
ACTIVE_NOT_RECRUITING
Debrecen
Research Site
ACTIVE_NOT_RECRUITING
Győr
Research Site
ACTIVE_NOT_RECRUITING
Gyula
Research Site
ACTIVE_NOT_RECRUITING
Kaposvár
Research Site
ACTIVE_NOT_RECRUITING
Miskolc
Research Site
ACTIVE_NOT_RECRUITING
Nyíregyháza
Research Site
ACTIVE_NOT_RECRUITING
Szekszárd
Research Site
WITHDRAWN
Szolnok
India
Research Site
RECRUITING
Bangalore
Research Site
ACTIVE_NOT_RECRUITING
Bangalore
Research Site
RECRUITING
Belagavi
Research Site
WITHDRAWN
Bhubaneswar
Research Site
ACTIVE_NOT_RECRUITING
Hubli
Research Site
WITHDRAWN
Hyderabad
Research Site
WITHDRAWN
Jaipur
Research Site
ACTIVE_NOT_RECRUITING
Kolkata
Research Site
ACTIVE_NOT_RECRUITING
Mumbai
Research Site
RECRUITING
Nagpur
Research Site
ACTIVE_NOT_RECRUITING
Nashik
Research Site
WITHDRAWN
New Delhi
Research Site
WITHDRAWN
New Delhi
Research Site
ACTIVE_NOT_RECRUITING
New Delhi
Research Site
RECRUITING
Pune
Research Site
ACTIVE_NOT_RECRUITING
Pune
Research Site
ACTIVE_NOT_RECRUITING
Thāne
Research Site
ACTIVE_NOT_RECRUITING
Visakhapatnam
Research Site
ACTIVE_NOT_RECRUITING
West Bengal
Israel
Research Site
ACTIVE_NOT_RECRUITING
Afula
Research Site
RECRUITING
Ashdod
Research Site
ACTIVE_NOT_RECRUITING
Haifa
Research Site
ACTIVE_NOT_RECRUITING
Jerusalem
Research Site
ACTIVE_NOT_RECRUITING
Jerusalem
Research Site
ACTIVE_NOT_RECRUITING
Kfar Saba
Research Site
ACTIVE_NOT_RECRUITING
Nahariya
Research Site
ACTIVE_NOT_RECRUITING
Ramat Gan
Research Site
ACTIVE_NOT_RECRUITING
Rehovot
Research Site
WITHDRAWN
Tel Aviv
Italy
Research Site
ACTIVE_NOT_RECRUITING
Bari
Research Site
ACTIVE_NOT_RECRUITING
Catania
Research Site
ACTIVE_NOT_RECRUITING
Catanzaro
Research Site
ACTIVE_NOT_RECRUITING
Florence
Research Site
ACTIVE_NOT_RECRUITING
Genova
Research Site
ACTIVE_NOT_RECRUITING
Grosseto
Research Site
ACTIVE_NOT_RECRUITING
Milan
Research Site
ACTIVE_NOT_RECRUITING
Milan
Research Site
ACTIVE_NOT_RECRUITING
Modena
Research Site
WITHDRAWN
Napoli
Research Site
ACTIVE_NOT_RECRUITING
Napoli
Research Site
ACTIVE_NOT_RECRUITING
Pisa
Research Site
ACTIVE_NOT_RECRUITING
Reggio Emilia
Research Site
ACTIVE_NOT_RECRUITING
Roma
Research Site
ACTIVE_NOT_RECRUITING
Rozzano
Research Site
ACTIVE_NOT_RECRUITING
Turin
Japan
Research Site
ACTIVE_NOT_RECRUITING
Chiba
Research Site
ACTIVE_NOT_RECRUITING
Chūōku
Research Site
ACTIVE_NOT_RECRUITING
Fukuoka
Research Site
ACTIVE_NOT_RECRUITING
Fukushima
Research Site
ACTIVE_NOT_RECRUITING
Hidaka-shi
Research Site
ACTIVE_NOT_RECRUITING
Hirakata-shi
Research Site
ACTIVE_NOT_RECRUITING
Hiroshima
Research Site
ACTIVE_NOT_RECRUITING
Isehara-shi
Research Site
ACTIVE_NOT_RECRUITING
Kagoshima
Research Site
ACTIVE_NOT_RECRUITING
Kashiwa
Research Site
ACTIVE_NOT_RECRUITING
Kitaadachi-gun
Research Site
ACTIVE_NOT_RECRUITING
Kōtoku
Research Site
ACTIVE_NOT_RECRUITING
Kumamoto
Research Site
ACTIVE_NOT_RECRUITING
Kurume-shi
Research Site
ACTIVE_NOT_RECRUITING
Kyoto
Research Site
ACTIVE_NOT_RECRUITING
Matsuyama
Research Site
ACTIVE_NOT_RECRUITING
Nagoya
Research Site
ACTIVE_NOT_RECRUITING
Nagoya
Research Site
ACTIVE_NOT_RECRUITING
Nagoya
Research Site
ACTIVE_NOT_RECRUITING
Niigata
Research Site
ACTIVE_NOT_RECRUITING
Ōita
Research Site
ACTIVE_NOT_RECRUITING
Osaka
Research Site
ACTIVE_NOT_RECRUITING
Osaka
Research Site
ACTIVE_NOT_RECRUITING
Osaka
Research Site
ACTIVE_NOT_RECRUITING
Ota-shi
Research Site
ACTIVE_NOT_RECRUITING
Sagamihara-shi
Research Site
ACTIVE_NOT_RECRUITING
Sapporo
Research Site
ACTIVE_NOT_RECRUITING
Sendai
Research Site
ACTIVE_NOT_RECRUITING
Shinagawa-ku
Research Site
ACTIVE_NOT_RECRUITING
Suita-shi
Research Site
ACTIVE_NOT_RECRUITING
Sunto-gun
Research Site
ACTIVE_NOT_RECRUITING
Takasaki-shi
Research Site
ACTIVE_NOT_RECRUITING
Tsu
Research Site
ACTIVE_NOT_RECRUITING
Yokohama
Malaysia
Research Site
ACTIVE_NOT_RECRUITING
George Town
Research Site
ACTIVE_NOT_RECRUITING
George Town
Research Site
ACTIVE_NOT_RECRUITING
Johor Bahru
Research Site
ACTIVE_NOT_RECRUITING
Kota Bharu
Research Site
ACTIVE_NOT_RECRUITING
Kuala Lumpur
Research Site
ACTIVE_NOT_RECRUITING
Kuala Lumpur
Research Site
ACTIVE_NOT_RECRUITING
Kuala Lumpur
Research Site
ACTIVE_NOT_RECRUITING
Kuching
Research Site
ACTIVE_NOT_RECRUITING
Malacca
Research Site
ACTIVE_NOT_RECRUITING
Sabak Bernam
Mexico
Research Site
ACTIVE_NOT_RECRUITING
Aguascalientes
Research Site
ACTIVE_NOT_RECRUITING
Alc. Cuauhtémoc
Research Site
WITHDRAWN
Colonia Lindavista
Research Site
ACTIVE_NOT_RECRUITING
Mérida
Research Site
ACTIVE_NOT_RECRUITING
México
Research Site
WITHDRAWN
México
Research Site
ACTIVE_NOT_RECRUITING
México
Research Site
ACTIVE_NOT_RECRUITING
Mexico City
Research Site
NOT_YET_RECRUITING
Monterrey
Research Site
ACTIVE_NOT_RECRUITING
Monterrey
Research Site
WITHDRAWN
Monterrey
Research Site
WITHDRAWN
Monterrey
Research Site
RECRUITING
San Luis Potosí City
Research Site
ACTIVE_NOT_RECRUITING
Toluca
Research Site
ACTIVE_NOT_RECRUITING
Veracruz
Research Site
ACTIVE_NOT_RECRUITING
Veracruz
Netherlands
Research Site
ACTIVE_NOT_RECRUITING
Dirksland
Research Site
ACTIVE_NOT_RECRUITING
Geleen
Research Site
WITHDRAWN
Groningen
Research Site
WITHDRAWN
Hoofddorp
Research Site
WITHDRAWN
Rotterdam
Research Site
ACTIVE_NOT_RECRUITING
Rotterdam
Peru
Research Site
ACTIVE_NOT_RECRUITING
Arequipa
Research Site
WITHDRAWN
Arequipa
Research Site
ACTIVE_NOT_RECRUITING
Arequipa
Research Site
NOT_YET_RECRUITING
Arequipa
Research Site
WITHDRAWN
Callao
Research Site
WITHDRAWN
La Libertad
Research Site
WITHDRAWN
Lima
Research Site
ACTIVE_NOT_RECRUITING
Lima
Research Site
WITHDRAWN
Lima
Research Site
ACTIVE_NOT_RECRUITING
Lima
Research Site
ACTIVE_NOT_RECRUITING
Trujillo
Philippines
Research Site
ACTIVE_NOT_RECRUITING
Bacolod
Research Site
ACTIVE_NOT_RECRUITING
Cebu
Research Site
WITHDRAWN
Iloilo City
Research Site
WITHDRAWN
Manila
Research Site
ACTIVE_NOT_RECRUITING
Quezon City
Research Site
ACTIVE_NOT_RECRUITING
Quezon City
Research Site
RECRUITING
Quezon City
Poland
Research Site
ACTIVE_NOT_RECRUITING
Bialystok
Research Site
ACTIVE_NOT_RECRUITING
Grudziądz
Research Site
RECRUITING
Koszalin
Research Site
RECRUITING
Lodz
Research Site
ACTIVE_NOT_RECRUITING
Lublin
Research Site
ACTIVE_NOT_RECRUITING
Opole
Research Site
ACTIVE_NOT_RECRUITING
Poznan
Research Site
ACTIVE_NOT_RECRUITING
Racibórz
Research Site
ACTIVE_NOT_RECRUITING
Rzeszów
Research Site
ACTIVE_NOT_RECRUITING
Warsaw
Research Site
ACTIVE_NOT_RECRUITING
Wieliszew
Portugal
Research Site
RECRUITING
Amadora
Research Site
RECRUITING
Braga
Research Site
ACTIVE_NOT_RECRUITING
Guimarães
Research Site
ACTIVE_NOT_RECRUITING
Lisbon
Research Site
ACTIVE_NOT_RECRUITING
Lisbon
Research Site
ACTIVE_NOT_RECRUITING
Matosinhos Municipality
Research Site
ACTIVE_NOT_RECRUITING
Porto
Research Site
ACTIVE_NOT_RECRUITING
Porto
Research Site
ACTIVE_NOT_RECRUITING
Porto
Research Site
ACTIVE_NOT_RECRUITING
Vila Nova De Gaia
Republic of Korea
Research Site
ACTIVE_NOT_RECRUITING
Busan
Research Site
ACTIVE_NOT_RECRUITING
Daegu
Research Site
RECRUITING
Donggu
Research Site
ACTIVE_NOT_RECRUITING
Goyang-si
Research Site
ACTIVE_NOT_RECRUITING
Jeonnam
Research Site
RECRUITING
Seongbuk-gu
Research Site
ACTIVE_NOT_RECRUITING
Seoul
Research Site
ACTIVE_NOT_RECRUITING
Seoul
Research Site
ACTIVE_NOT_RECRUITING
Seoul
Research Site
ACTIVE_NOT_RECRUITING
Seoul
Research Site
ACTIVE_NOT_RECRUITING
Seoul
Research Site
ACTIVE_NOT_RECRUITING
Seoul
Research Site
ACTIVE_NOT_RECRUITING
Seoul
Romania
Research Site
RECRUITING
Baia Mare
Research Site
ACTIVE_NOT_RECRUITING
Brasov
Research Site
ACTIVE_NOT_RECRUITING
Cluj-napoca
Research Site
ACTIVE_NOT_RECRUITING
Cluj-napoca
Research Site
ACTIVE_NOT_RECRUITING
Constanța
Research Site
ACTIVE_NOT_RECRUITING
Craiova
Research Site
ACTIVE_NOT_RECRUITING
Craiova
Research Site
ACTIVE_NOT_RECRUITING
Craiova
Research Site
ACTIVE_NOT_RECRUITING
Floreşti
Research Site
ACTIVE_NOT_RECRUITING
Iași
Research Site
RECRUITING
Oradea
Research Site
ACTIVE_NOT_RECRUITING
Piteşti
Research Site
ACTIVE_NOT_RECRUITING
Sibiu
Research Site
ACTIVE_NOT_RECRUITING
Timișoara
Research Site
RECRUITING
Timișoara
Serbia
Research Site
ACTIVE_NOT_RECRUITING
Belgrade
Research Site
ACTIVE_NOT_RECRUITING
Belgrade
Research Site
ACTIVE_NOT_RECRUITING
Belgrade
Research Site
ACTIVE_NOT_RECRUITING
Kamenitz
Research Site
ACTIVE_NOT_RECRUITING
Kragujevac
Research Site
ACTIVE_NOT_RECRUITING
Niš
Research Site
ACTIVE_NOT_RECRUITING
Valjevo
Research Site
ACTIVE_NOT_RECRUITING
Zrenjanin
Singapore
Research Site
ACTIVE_NOT_RECRUITING
Singapore
Research Site
ACTIVE_NOT_RECRUITING
Singapore
Research Site
ACTIVE_NOT_RECRUITING
Singapore
Research Site
ACTIVE_NOT_RECRUITING
Singapore
South Africa
Research Site
WITHDRAWN
Bloemfontein
Research Site
ACTIVE_NOT_RECRUITING
Bloemfontein
Research Site
ACTIVE_NOT_RECRUITING
Emanzimtoti
Research Site
ACTIVE_NOT_RECRUITING
George
Research Site
RECRUITING
George
Research Site
ACTIVE_NOT_RECRUITING
Johannesburg
Research Site
ACTIVE_NOT_RECRUITING
Johannesburg
Research Site
WITHDRAWN
Pietermaritzburg
Research Site
WITHDRAWN
Pretoria
Research Site
ACTIVE_NOT_RECRUITING
Pretoria
Research Site
ACTIVE_NOT_RECRUITING
Soweto
Spain
Research Site
ACTIVE_NOT_RECRUITING
A Coruña
Research Site
ACTIVE_NOT_RECRUITING
A Coruña
Research Site
ACTIVE_NOT_RECRUITING
Albacete
Research Site
ACTIVE_NOT_RECRUITING
Alcoy
Research Site
ACTIVE_NOT_RECRUITING
Alicante
Research Site
ACTIVE_NOT_RECRUITING
Alzira
Research Site
ACTIVE_NOT_RECRUITING
Badajoz
Research Site
RECRUITING
Badalona
Research Site
ACTIVE_NOT_RECRUITING
Badalona
Research Site
ACTIVE_NOT_RECRUITING
Barakaldo
Research Site
RECRUITING
Barcelona
Research Site
ACTIVE_NOT_RECRUITING
Barcelona
Research Site
RECRUITING
Barcelona
Research Site
ACTIVE_NOT_RECRUITING
Cáceres
Research Site
ACTIVE_NOT_RECRUITING
Elche(alicante)
Research Site
ACTIVE_NOT_RECRUITING
Galdakao
Research Site
ACTIVE_NOT_RECRUITING
Girona
Research Site
ACTIVE_NOT_RECRUITING
Granada
Research Site
ACTIVE_NOT_RECRUITING
Granada
Research Site
ACTIVE_NOT_RECRUITING
Jerez De La Frontera (cádiz)
Research Site
ACTIVE_NOT_RECRUITING
L'hospitalet De Llobregat
Research Site
ACTIVE_NOT_RECRUITING
Leganés
Research Site
ACTIVE_NOT_RECRUITING
Lleida
Research Site
ACTIVE_NOT_RECRUITING
Madrid
Research Site
ACTIVE_NOT_RECRUITING
Madrid
Research Site
ACTIVE_NOT_RECRUITING
Madrid
Research Site
ACTIVE_NOT_RECRUITING
Majadahonda
Research Site
ACTIVE_NOT_RECRUITING
Manresa
Research Site
ACTIVE_NOT_RECRUITING
Murcia
Research Site
ACTIVE_NOT_RECRUITING
Oviedo
Research Site
ACTIVE_NOT_RECRUITING
Parla
Research Site
ACTIVE_NOT_RECRUITING
Port De Sagunt
Research Site
ACTIVE_NOT_RECRUITING
Reus
Research Site
ACTIVE_NOT_RECRUITING
Salamanca
Research Site
ACTIVE_NOT_RECRUITING
San Sebastián
Research Site
NOT_YET_RECRUITING
Sant Joan D'alacant
Research Site
ACTIVE_NOT_RECRUITING
Santander
Research Site
ACTIVE_NOT_RECRUITING
Seville
Research Site
ACTIVE_NOT_RECRUITING
Seville
Research Site
ACTIVE_NOT_RECRUITING
Teruel
Research Site
WITHDRAWN
Toledo
Research Site
ACTIVE_NOT_RECRUITING
Valencia
Research Site
ACTIVE_NOT_RECRUITING
Valencia
Research Site
ACTIVE_NOT_RECRUITING
Valencia
Taiwan
Research Site
ACTIVE_NOT_RECRUITING
Hsinchu
Research Site
ACTIVE_NOT_RECRUITING
Kaohsiung City
Research Site
RECRUITING
Taichung
Research Site
ACTIVE_NOT_RECRUITING
Tainan City
Research Site
ACTIVE_NOT_RECRUITING
Tainan City
Research Site
ACTIVE_NOT_RECRUITING
Taipei
Research Site
ACTIVE_NOT_RECRUITING
Taipei
Research Site
ACTIVE_NOT_RECRUITING
Taipei
Thailand
Research Site
ACTIVE_NOT_RECRUITING
Bangkok
Research Site
ACTIVE_NOT_RECRUITING
Bangkok
Research Site
ACTIVE_NOT_RECRUITING
Khon Kaen
Research Site
ACTIVE_NOT_RECRUITING
Phisanulok
Research Site
ACTIVE_NOT_RECRUITING
Phitsanulok
Research Site
ACTIVE_NOT_RECRUITING
Rachathewi
Research Site
ACTIVE_NOT_RECRUITING
Songkhla
Turkey
Research Site
WITHDRAWN
Ankara
Research Site
WITHDRAWN
Ankara
Research Site
ACTIVE_NOT_RECRUITING
Ankara
Research Site
ACTIVE_NOT_RECRUITING
Ankara
Research Site
ACTIVE_NOT_RECRUITING
Ankara
Research Site
ACTIVE_NOT_RECRUITING
Aydin
Research Site
WITHDRAWN
Bursa
Research Site
ACTIVE_NOT_RECRUITING
Dinar
Research Site
WITHDRAWN
Istanbul
Research Site
ACTIVE_NOT_RECRUITING
Istanbul
Research Site
WITHDRAWN
Istanbul
Research Site
ACTIVE_NOT_RECRUITING
Izmir
Research Site
ACTIVE_NOT_RECRUITING
Izmir
Research Site
ACTIVE_NOT_RECRUITING
Izmir
Research Site
WITHDRAWN
Izmir
Research Site
ACTIVE_NOT_RECRUITING
Samsun
United Kingdom
Research Site
ACTIVE_NOT_RECRUITING
Brighton
Research Site
ACTIVE_NOT_RECRUITING
Burton-on-trent
Research Site
ACTIVE_NOT_RECRUITING
Cambridge
Research Site
ACTIVE_NOT_RECRUITING
Derby
Research Site
ACTIVE_NOT_RECRUITING
Edinburgh
Research Site
WITHDRAWN
Guildford
Research Site
ACTIVE_NOT_RECRUITING
Ipswich
Research Site
RECRUITING
Keighley
Research Site
RECRUITING
London
Research Site
ACTIVE_NOT_RECRUITING
London
Research Site
ACTIVE_NOT_RECRUITING
Manchester
Research Site
ACTIVE_NOT_RECRUITING
Oxford
Research Site
NOT_YET_RECRUITING
Peterborough
Research Site
RECRUITING
Stoke-on-trent
Research Site
ACTIVE_NOT_RECRUITING
Sutton
Viet Nam
Research Site
ACTIVE_NOT_RECRUITING
Hanoi
Research Site
ACTIVE_NOT_RECRUITING
Ho Chi Minh City
Research Site
ACTIVE_NOT_RECRUITING
Ho Chi Minh City
Research Site
WITHDRAWN
Huế
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Backup
AstraZeneca Breast Cancer Study Locator Service
az-bcsl@careboxhealth.com
1-877-400-4655
Time Frame
Start Date: 2023-03-31
Estimated Completion Date: 2036-05-29
Participants
Target number of participants: 4300
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca