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ACTIVE NOT RECRUITINGPhase3

An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

Sponsor: AstraZeneca

NCT ID: NCT05952557

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Camizestrant (drug), Tamoxifen (drug), Anastrozole (drug), Letrozole (drug)
How long the study runs
Study runs about 163 months (dates as stated)
About the drug or intervention
Camizestrant — drug: Camizestrant. · Tamoxifen — drug: Tamoxifen. · Anastrozole — drug: Anastrozole. · Letrozole — drug: Letrozole. · Exemestane — drug: Exemestane. · Abemaciclib — drug: Abemaciclib adjuvant treatment Administered orally
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 130 Years
Who
All
Number of participants
5,511
Started
2023-10-05
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for breast cancer, early breast cancer
  • • Phase3 - 5,511 participants
  • • 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)

Who can take part?

  • • Ages 18 Years to 130 Years
  • • Diagnosed with breast cancer, early breast cancer

Where?

  • • Aberdeen - Research Site
  • • Burton-on-Trent - Research Site
  • • Cambridge - Research Site
  • • Derby - Research Site
  • • +16 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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 of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Breast Cancer, Early Breast Cancer

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 130 Years
  • Who can join: All genders

Biomarkers mentioned

ERHER2with positive

What the study is looking for

  • ✓Women and Men; ≥18 years at the time of screening (or per national guidelines)
  • ✓confirmed by a biopsy ER+/HER2- early-stage resected invasive breast cancer with absence of any evidence of...
  • ✓Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast...
  • ✓Patients must be randomly assigned within 12 months of definitive breast surgery.
  • ✓Patients may have received up to 12 weeks of endocrine therapy prior to randomisation.

Who cannot take part

  • ✗Inoperable that has grown locally or that has spread breast cancer
  • ✗Pathological complete response following treatment with before surgery therapy
  • ✗Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes...
  • ✗Known LVEF \<50% with heart failure NYHA Grade ≥2.
  • ✗Mean resting QTcF interval \> 480 ms at screening
See the full criteria
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.

Where Is This Study? (20 UK sites)

Research Site

Aberdeen AB25 2ZN, United Kingdom

Research Site

Burton-on-Trent DE13 0RB, United Kingdom

Research Site

Cambridge CB2 2QQ, United Kingdom

Research Site

Derby DE22 3NE, United Kingdom

Research Site

Guildford GU27XX, United Kingdom

Research Site

Ipswich IP4 5PD, United Kingdom

Research Site

Lancaster LA1 4RP, United Kingdom

Research Site

Leeds LS9 7TF, United Kingdom

Research Site

Leicester LE1 5WW, United Kingdom

Research Site

London EC1M 6BQ, United Kingdom

Research Site

London NW3 2QG, United Kingdom

Research Site

London SE1 9RT, United Kingdom

Research Site

London SW2 6JJ, United Kingdom

Research Site

Manchester M20 4BX, United Kingdom

Research Site

Northampton NN1 5BD, United Kingdom

Research Site

Shrewsbury SY3 8XQ, United Kingdom

Research Site

Sutton SM2 5PT, United Kingdom

Research Site

Sutton in Ashfield NG17 4JL, United Kingdom

Research Site

Taunton TA1 5DA, United Kingdom

Research Site

Whitchurch CF14 2TL, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-08