A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
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
AstraZeneca
4,300 participants
Mar 31, 2023
INTERVENTIONAL
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
Inclusion Criteria6
- 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
Exclusion Criteria11
- 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 sex hormone therapy
- 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
Interventions
Camizestrant. Experimental. Administered orally
Tamoxifen. Comparator. Administered per local approved label
Anastrozole. Comparator. Administered per local approved label
Letrozole. Comparator. Administered per local approved label
Exemestane. Comparator. Administered per local approved label
Locations(727)
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Birmingham, Alabama, United States
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Dothan, Alabama, United States
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Anchorage, Alaska, United States
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Chandler, Arizona, United States
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Hot Springs, Arkansas, United States
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Anaheim, California, United States
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Beverly Hills, California, United States
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Concord, California, United States
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Corona, California, United States
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Fountain Valley, California, United States
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Greenbrae, California, United States
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Los Alamitos, California, United States
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Palo Alto, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Whittier, California, United States
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Aurora, Colorado, United States
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Hartford, Connecticut, United States
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Fort Myers, Florida, United States
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Gainesville, Florida, United States
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Orlando, Florida, United States
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Plantation, Florida, United States
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Port Saint Lucie, Florida, United States
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Saint Augustine, Florida, United States
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St. Petersburg, Florida, United States
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Winter Haven, Florida, United States
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Pretoria, South Africa
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Soweto, South Africa
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Busan, South Korea
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Daegu, South Korea
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Donggu, South Korea
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Goyang-si, South Korea
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Jeonnam, South Korea
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Seongbuk-Gu, South Korea
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Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
A Coruña, Spain
Research Site
A Coruña, Spain
Research Site
Albacete, Spain
Research Site
Alcoy, Spain
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Alicante, Spain
Research Site
Alzira, Spain
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Badajoz, Spain
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Badalona, Spain
Research Site
Badalona, Spain
Research Site
Barakaldo, Spain
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Barcelona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Cáceres, Spain
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Elche(Alicante), Spain
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Galdakao, Spain
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Girona, Spain
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Granada, Spain
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Granada, Spain
Research Site
Jerez de La Frontera (Cádiz), Spain
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L'Hospitalet de Llobregat, Spain
Research Site
Leganés, Spain
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Lleida, Spain
Research Site
Madrid, Spain
Research Site
Madrid, Spain
Research Site
Madrid, Spain
Research Site
Madrid, Spain
Research Site
Majadahonda, Spain
Research Site
Manresa, Spain
Research Site
Murcia, Spain
Research Site
Oviedo, Spain
Research Site
Parla, Spain
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Port de Sagunt, Spain
Research Site
Reus, Spain
Research Site
Salamanca, Spain
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San Sebastián, Spain
Research Site
Sant Joan d'Alacant, Spain
Research Site
Santander, Spain
Research Site
Seville, Spain
Research Site
Seville, Spain
Research Site
Teruel, Spain
Research Site
Toledo, Spain
Research Site
Valencia, Spain
Research Site
Valencia, Spain
Research Site
Valencia, Spain
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Hsinchu, Taiwan
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Kaohsiung City, Taiwan
Research Site
Taichung, Taiwan
Research Site
Tainan, Taiwan
Research Site
Tainan, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taipei, Taiwan
Research Site
Bangkok, Thailand
Research Site
Bangkok, Thailand
Research Site
Khon Kaen, Thailand
Research Site
Phisanulok, Thailand
Research Site
Phitsanulok, Thailand
Research Site
Rachathewi, Thailand
Research Site
Songkhla, Thailand
Research Site
Ankara, Turkey (Türkiye)
Research Site
Ankara, Turkey (Türkiye)
Research Site
Ankara, Turkey (Türkiye)
Research Site
Ankara, Turkey (Türkiye)
Research Site
Ankara, Turkey (Türkiye)
Research Site
Aydin, Turkey (Türkiye)
Research Site
Bursa, Turkey (Türkiye)
Research Site
Dinar, Turkey (Türkiye)
Research Site
Istanbul, Turkey (Türkiye)
Research Site
Istanbul, Turkey (Türkiye)
Research Site
Istanbul, Turkey (Türkiye)
Research Site
Izmir, Turkey (Türkiye)
Research Site
Izmir, Turkey (Türkiye)
Research Site
Izmir, Turkey (Türkiye)
Research Site
Izmir, Turkey (Türkiye)
Research Site
Samsun, Turkey (Türkiye)
Research Site
Brighton, United Kingdom
Research Site
Burton-on-Trent, United Kingdom
Research Site
Cambridge, United Kingdom
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Derby, United Kingdom
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Edinburgh, United Kingdom
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Guildford, United Kingdom
Research Site
Ipswich, United Kingdom
Research Site
Keighley, United Kingdom
Research Site
London, United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Oxford, United Kingdom
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Peterborough, United Kingdom
Research Site
Stoke-on-Trent, United Kingdom
Research Site
Sutton, United Kingdom
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Hanoi, Vietnam
Research Site
Ho Chi Minh City, Vietnam
Research Site
Ho Chi Minh City, Vietnam
Research Site
Huế, Vietnam
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NCT05774951