> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/an-adjuvant-endocrine-based-therapy-study-of-camizestrant-6df65d15-52dc-4caf-bfdc-2c2b8750dc03 > Record changed: 2026-10-13 # An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2) NCT05952557 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) Participants 5,511 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) Start date 2023-10-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) Number of sites 661 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) **Acronym** CAMBRIA-2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) **Short title** An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) ## Dates **Completion date** 2037-05-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) **First posted** 2023-07-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) **Registry last updated** 2026-08-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) **Primary completion date** 2030-03-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) **Start date** 2023-10-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) ## Size and sites **Actual participants** 5,511 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) **Participants** 5,511 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) **Number of sites** 661 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) ## Identifiers **Registry ID** NCT05952557 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) **ClinicalTrials.gov ID** NCT05952557 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) ## Outcomes ### Primary outcomes 1. Invasive breast cancer-free survival (IBCFS) Timeframe: Up to 14 years IBCFS is defined as time from randomisation until date of first occurrence of: \* Invasive ipsilateral breast tumour recurrence \* Locoregional invasive breast cancer recurrence \* Distant recurrence \* Contralateral invasive breast cancer \* Death attributable to any cause. ### Secondary outcomes 1. Invasive disease-free survival (IDFS) Timeframe: Up to 14 years IDFS is defined as time from randomisation until date of first occurrence of one of the following events: \* Invasive ipsilateral breast tumor recurrence \* Locoregional invasive breast cancer recurrence \* Distant recurrence \* Contralateral invasive breast cancer \* Second primary non-breast invasive cancer \* Death attributable to any cause. 2. Distant relapse-free survival (DRFS) Timeframe: Up to 14 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 14 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 7 years) 5. Proportion of time on study treatment with high side-effect burden as measured by the PGI-TT. Timeframe: Until 28 days after the final dose of study treatment (up to 7 years) 6. Change from baseline and time to deterioration of health-related quality of life as measured by the 2 global QoL items from the EORTC IL-311 Timeframe: Until 28 days after the final dose of study treatment (up to 7 years) 7. Pharmacokinetics (PK) Timeframe: Until 6 months from treatment start Plasma concentrations of camizestrant pre-dose (trough concentration) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) ## 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 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 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 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) ## Sites - Research SiteDothan, United States - Research SitePhoenix, United States - Research SiteTucson, United States - Research SiteFayetteville, United States - Research SiteDuarte, United States - Research SiteFountain Valley, United States - Research SiteIrvine, United States - Research SiteLa Jolla, United States - Research SiteLos Angeles, United States - Research SiteWalnut Creek, United States - Research SiteWest Hollywood, United States - Research SiteAurora, United States - Research SiteLittleton, United States - Research SiteLittleton, United States - Research SiteNew Haven, United States - Research SiteNewark, United States - Research SiteClearwater, United States - Research SiteFort Myers, United States - Research SiteGainesville, United States - Research SiteJacksonville, United States - Research SitePembroke Pines, United States - Research SitePlantation, United States - Research SitePlantation, United States - Research SiteSt. Petersburg, United States - Research SiteSt. Petersburg, United States And 636 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) ## 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/411695) ### Other registry identifiers (2) - 2023 - 2023-504031-41-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05952557) ## Related records ### Drugs (6) - [Abemaciclib](https://trialight.com/data/asset/abemaciclib-602a9f33-bc37-4cf5-8790-5d87472b99d5.md) - [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) ### Collaborators (1) - Austrian Breast & Colorectal Cancer Study Group ### 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 (4) - [CDK4](https://trialight.com/data/target/cdk4-7911e947-47b0-5d57-b5c3-76425934201f.md) - [CDK6](https://trialight.com/data/target/cdk6-a48645cb-6daf-5fe9-a635-f8d00b55b425.md) - [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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