An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)
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
AstraZeneca
5,500 participants
Oct 5, 2023
INTERVENTIONAL
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.
Eligibility
Inclusion Criteria7
- 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
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 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.
Interventions
Camizestrant. Experimental. Administered orally
Tamoxifen. Comparator. Administered orally
Anastrozole. Comparator. Administered orally
Letrozole. Comparator. Administered orally
Exemestane. Comparator. Administered orally
Abemaciclib adjuvant treatment Administered orally
Locations(794)
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Milan, Italy
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Misterbianco, Italy
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Modena, Italy
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Monza, Italy
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Napoli, Italy
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Novara, Italy
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Padua, Italy
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Roma, Italy
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Roma, Italy
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Rozzano, Italy
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Torino, Italy
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Trento, Italy
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Lima, Peru
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Linz, Austria
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Salzburg, Austria
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Huizhou, China
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Lanzhou, China
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Linyi, China
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Liuchow, China
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Liuchow, China
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Nanchang, China
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Paris, France
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Rio, Greece
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Dothan, Alabama, United States
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Porto, Portugal
Research Site
Viana do Castelo, Portugal
Research Site
Vila Nova de Gaia, Portugal
Research Site
Vila Real, Portugal
Research Site
Rio Piedras, Puerto Rico
Research Site
Bucharest, Romania
Research Site
Bucharest, Romania
Research Site
Cluj-Napoca, Romania
Research Site
Cluj-Napoca, Romania
Research Site
Craiova, Romania
Research Site
Craiova, Romania
Research Site
Craiova, Romania
Research Site
Floreşti, Romania
Research Site
Iași, Romania
Research Site
Oradea, Romania
Research Site
Otopeni, Romania
Research Site
Ovidiu, Romania
Research Site
Piteşti, Romania
Research Site
Sibiu, Romania
Research Site
Timișoara, Romania
Research Site
Timișoara, Romania
Research Site
Riyadh, Saudi Arabia
Research Site
Riyadh, Saudi Arabia
Research Site
Riyadh/MENA, Saudi Arabia
Research Site
Belgrade, Serbia
Research Site
Belgrade, Serbia
Research Site
Belgrade, Serbia
Research Site
Kragujevac, Serbia
Research Site
Niš, Serbia
Research Site
Novi Sad, Serbia
Research Site
Valjevo, Serbia
Research Site
Zrenjanin, Serbia
Research Site
Bloemfontein, South Africa
Research Site
Cape Town, South Africa
Research Site
eManzimtoti, South Africa
Research Site
George, South Africa
Research Site
Johannesburg, South Africa
Research Site
Johannesburg, South Africa
Research Site
Pietermaritzburg, South Africa
Research Site
Port Elizabeth, South Africa
Research Site
Pretoria, South Africa
Research Site
Cheonan-si, South Korea
Research Site
Daegu, South Korea
Research Site
Goyang-si, South Korea
Research Site
Seongnam-si, 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
Seoul, South Korea
Research Site
A Coruña, Spain
Research Site
A Coruña, Spain
Research Site
Albacete, Spain
Research Site
Alicante, Spain
Research Site
Badalona, Spain
Research Site
Barakaldo, Spain
Research Site
Barcelona, Spain
Research Site
Barcelona, Spain
Research Site
Barcelona, Spain
Research Site
Barcelona, Spain
Research Site
Burgos, Spain
Research Site
Castellon, Spain
Research Site
Cáceres, Spain
Research Site
Córdoba, Spain
Research Site
Donostia / San Sebastian, Spain
Research Site
El Palmar, Spain
Research Site
Elche(Alicante), Spain
Research Site
Fuenlabrada, Spain
Research Site
Girona, Spain
Research Site
Granada, Spain
Research Site
Granada, Spain
Research Site
Jerez de la Frontera, Spain
Research Site
La Laguna (Tenerife), Spain
Research Site
León, Spain
Research Site
Lleida, Spain
Research Site
Madrid, Spain
Research Site
Madrid, Spain
Research Site
Madrid, Spain
Research Site
Madrid, Spain
Research Site
Madrid, Spain
Research Site
Madrid, Spain
Research Site
Madrid, Spain
Research Site
Manresa, Spain
Research Site
Málaga, Spain
Research Site
Málaga, Spain
Research Site
Murcia, Spain
Research Site
Palma de Mallorca, Spain
Research Site
Reus,Tarragona, Spain
Research Site
Sabadell, Spain
Research Site
Salamanca, Spain
Research Site
Sant Joan Despí, Spain
Research Site
Seville, Spain
Research Site
Seville, Spain
Research Site
Seville, Spain
Research Site
Toledo, Spain
Research Site
Valencia, Spain
Research Site
Valencia, Spain
Research Site
Valencia, Spain
Research Site
Vigo, Spain
Research Site
Zaragoza, Spain
Research Site
Baden, Switzerland
Research Site
Basel, Switzerland
Research Site
Bellinzona, Switzerland
Research Site
Chur, Switzerland
Research Site
Frauenfeld, Switzerland
Research Site
La Chaux-de-Fonds, Switzerland
Research Site
Lausanne, Switzerland
Research Site
Lucerne, Switzerland
Research Site
Lucerne, Switzerland
Research Site
Sankt Gallen, Switzerland
Research Site
Winterthur, Switzerland
Research Site
Zurich, Switzerland
Research Site
Hsinchu, Taiwan
Research Site
Kaohsiung City, Taiwan
Research Site
New Taipei City, Taiwan
Research Site
Taichung, Taiwan
Research Site
Taichung, Taiwan
Research Site
Tainan, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taipei, Taiwan
Research Site
Yongkang District, Taiwan
Research Site
Bangkok, Thailand
Research Site
Bangkok, Thailand
Research Site
Bangkok, Thailand
Research Site
Bangkok, Thailand
Research Site
Hat Yai, Thailand
Research Site
Khon Kaen, Thailand
Research Site
Ankara, Turkey (Türkiye)
Research Site
Ankara, Turkey (Türkiye)
Research Site
Ankara, Turkey (Türkiye)
Research Site
Ankara, Turkey (Türkiye)
Research Site
Antalya, Turkey (Türkiye)
Research Site
Bursa, Turkey (Türkiye)
Research Site
Cordaleo, Turkey (Türkiye)
Research Site
Çankaya, Turkey (Türkiye)
Research Site
Çiğli, Turkey (Türkiye)
Research Site
Edirne, Turkey (Türkiye)
Research Site
Istanbul, Turkey (Türkiye)
Research Site
Istanbul, Turkey (Türkiye)
Research Site
Istanbul, Turkey (Türkiye)
Research Site
Istanbul, Turkey (Türkiye)
Research Site
Istanbul, Turkey (Türkiye)
Research Site
Istanbul, Turkey (Türkiye)
Research Site
Malatya, Turkey (Türkiye)
Research Site
Samsun, Turkey (Türkiye)
Research Site
Abu Dhabi, United Arab Emirates
Research Site
Al Ain City, United Arab Emirates
Research Site
Dubai, United Arab Emirates
Research Site
Dubai, United Arab Emirates
Research Site
Aberdeen, United Kingdom
Research Site
Bath, United Kingdom
Research Site
Brighton, United Kingdom
Research Site
Burton-on-Trent, United Kingdom
Research Site
Cambridge, United Kingdom
Research Site
Derby, United Kingdom
Research Site
Guildford, United Kingdom
Research Site
Ipswich, United Kingdom
Research Site
Lancaster, United Kingdom
Research Site
Leeds, United Kingdom
Research Site
Leicester, United Kingdom
Research Site
Liverpool, United Kingdom
Research Site
London, United Kingdom
Research Site
London, United Kingdom
Research Site
London, United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Northampton, United Kingdom
Research Site
Oxford, United Kingdom
Research Site
Reading, United Kingdom
Research Site
Shrewsbury, United Kingdom
Research Site
Stockton, United Kingdom
Research Site
Sutton, United Kingdom
Research Site
Sutton in Ashfield, United Kingdom
Research Site
Taunton, United Kingdom
Research Site
Warwick, United Kingdom
Research Site
Whitchurch, United Kingdom
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NCT05952557