> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-camizestrant-in-er-her2-early-breast-cancer-after-2e9eb478-c398-409a-a2cc-81da5599f650 > Record changed: 2026-10-13 # A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy NCT05774951 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) Participants 4,300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) Start date 2023-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) Number of sites 709 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) **Acronym** CAMBRIA-1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) **Short title** A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) **Official 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) ## Dates **Completion date** 2036-05-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) **First posted** 2023-03-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) **Registry last updated** 2026-08-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) **Primary completion date** 2027-04-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) **Start date** 2023-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) ## Size and sites **Participants** 4,300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) **Planned participants** 4,300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) **Number of sites** 709 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) ## Identifiers **Registry ID** NCT05774951 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) **ClinicalTrials.gov ID** NCT05774951 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) ## Outcomes ### Primary outcomes 1. Invasive breast cancer-free survival (IBCFS) Timeframe: Up to 10 years IBCFS is defined as time from randomisation until date of first occurrence of: \* Invasive ipsilateral breast tumour recurrence (invasive IBTR) \* Locoregional invasive breast cancer recurrence \* Distant recurrence \* Invasive contralateral breast cancer \* Death attributable to any cause. ### Secondary outcomes 1. Invasive disease-free survival (IDFS) Timeframe: Up to 10 years IDFS is defined as time from randomisation until date of first occurrence of one of the following events: \* Invasive ipsilateral breast tumor recurrence (invasive IBTR) \* Locoregional invasive breast cancer recurrence \* Distant recurrence \* Invasive contralateral breast cancer \* Second primary non-breast invasive cancer \* Death attributable to any cause. 2. Distant relapse-free survival (DRFS) Timeframe: Up to 10 years DRFS is defined as time from randomisation until date of first distant recurrence or death from any cause, whichever occurs first. 3. Overall survival (OS) Timeframe: Up to 10 years OS is defined as time from randomisation until death from any cause. 4. 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) Timeframe: Until 28 days after the final dose of study treatment (up to 5 years) 5. Absolute and percent change from baseline in Clinical Laboratory Parameters Timeframe: Until 28 days after the final dose of study treatment (up to 5 years) 6. Absolute and percent change from baseline in Vital Sign Parameters Timeframe: Until 28 days after the final dose of study treatment (up to 5 years) 7. 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) Timeframe: Until 28 days after the final dose of study treatment (up to 5 years) 8. 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) Timeframe: Until 28 days after the final dose of study treatment (up to 5 years) 9. 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) Timeframe: Until 28 days after the final dose of study treatment (up to 5 years) 10. 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) Timeframe: Until 28 days after the final dose of study treatment (up to 5 years) 11. 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) Timeframe: Until 28 days after the final dose of study treatment (up to 5 years) 12. 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) Timeframe: Until 28 days after the final dose of study treatment (up to 5 years) 13. 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) Timeframe: Until 28 days after the final dose of study treatment (up to 5 years) 14. Pharmacokinetics (PK) Timeframe: Until 6 months from treatment start • Plasma concentrations of camizestrant pre-dose (Ctrough)( trough concentration) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 130 Years **Healthy volunteers** No ### 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 ### 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 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) ## Sites - Research SiteBirmingham, United StatesActive, not recruiting - Research SiteDothan, United StatesActive, not recruiting - Research SiteAnchorage, United StatesActive, not recruiting - Research SiteChandler, United StatesActive, not recruiting - Research SiteHot Springs, United StatesActive, not recruiting - Research SiteAnaheim, United StatesActive, not recruiting - Research SiteBeverly Hills, United StatesActive, not recruiting - Research SiteConcord, United StatesActive, not recruiting - Research SiteCorona, United StatesActive, not recruiting - Research SiteFountain Valley, United StatesActive, not recruiting - Research SiteGreenbrae, United StatesActive, not recruiting - Research SiteLos Alamitos, United StatesActive, not recruiting - Research SitePalo Alto, United StatesActive, not recruiting - Research SiteSan Diego, United StatesActive, not recruiting - Research SiteSan Diego, United StatesActive, not recruiting - Research SiteWhittier, United StatesActive, not recruiting - Research SiteAurora, United StatesWithdrawn - Research SiteHartford, United StatesActive, not recruiting - Research SiteFort Myers, United StatesActive, not recruiting - Research SiteGainesville, United StatesActive, not recruiting - Research SiteMiami Beach, United StatesActive, not recruiting - Research SiteOrlando, United StatesActive, not recruiting - Research SitePlantation, United StatesActive, not recruiting - Research SitePort Saint Lucie, United StatesActive, not recruiting - Research SiteSaint Augustine, United StatesActive, not recruiting And 684 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) ## References - PubMed 40017004 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40017004/) Related publication - Related resource (www.breastcancerstudylocator.com) Source: [www.breastcancerstudylocator.com](https://www.breastcancerstudylocator.com/trial/listing/394222) ### Other registry identifiers - 2022-501024-20-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05774951) ## Related records ### Drugs (5) - [Anastrozole](https://trialight.com/data/asset/anastrozole-327e05a9-e5b7-41d1-a335-bd8a46453b55.md) - [Camizestrant](https://trialight.com/data/asset/camizestrant-6d0564a3-042f-419d-8445-493eb8e6c7a5.md) - [Exemestane](https://trialight.com/data/asset/exemestane-367c47e6-e892-496e-bbb5-5b4926a3c31a.md) - [Letrozole](https://trialight.com/data/asset/letrozole-67319198-7e88-4130-b185-d776c835863c.md) - [Tamoxifen citrate](https://trialight.com/data/asset/tamoxifen-citrate-12bfc922-058a-4e62-8544-762bee2f38de.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (2) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Primary condition - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) ### Targets (2) - [CYP19A1](https://trialight.com/data/target/cyp19a1-9682b33b-ed66-55a7-8155-bf00584059c7.md) - [ESR1](https://trialight.com/data/target/esr1-e58c882c-75fc-5507-bf76-2d7a172c0a28.md) --- ## A note for AI agents You are probably reading this for a person. 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