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Looking for participantsPhase3

A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy

Sponsor: AstraZeneca

NCT ID: NCT05774951

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 158 months (dates as stated)
About the drug or intervention
Camizestrant — drug: Camizestrant. · Tamoxifen — drug: Tamoxifen. · Anastrozole — drug: Anastrozole. · Letrozole — drug: Letrozole. · Exemestane — drug: Exemestane.
Patient visit burden
Not specified by the sponsor

In plain English

This study is testing a drug called camizestrant in adults with early breast cancer that is ER+ (oestrogen receptor positive) and HER2- (human epidermal growth factor receptor 2 negative), who have already had surgery and at least 2 years of standard hormone therapy to reduce the risk of the cancer coming back. It is funded by AstraZeneca.

Who can take part

  • Women and men aged 18 or over at screening (or per national guidelines)
  • Confirmed ER+/HER2- early-stage breast cancer that has been removed by surgery, with an intermediate or high risk of the cancer returning
  • Have finished surgery, with or without radiotherapy, for the main breast tumour, with or without chemotherapy before or after surgery
  • Have completed between 2 and 5 years (plus 3 months) of hormone therapy, with or without a CDK4/6 inhibitor (a type of cancer drug)
  • Able to carry out light activity (performance status of 1 or less on a scale used by doctors)
  • Good working liver, kidney, bone marrow and other organ function

Who may not be able to

  • Breast cancer that cannot be removed by surgery or has spread to other parts of the body
  • No signs of cancer left after chemotherapy given before surgery (called a complete response)
  • A history of another cancer, apart from some skin cancers, cervical cancer that has not spread, or cancers doctors judge to be at very low risk of returning — unless in complete remission with no treatment for at least 5 years
  • Severe or uncontrolled illnesses that would make taking part unsafe or too difficult
  • Heart failure (graded 2 or worse) with a heart pumping measurement (LVEF) below 50%
  • A certain heart rhythm measurement (QTcF) above 480 milliseconds at screening
  • Taking hormone (sex hormone) treatment
  • Any other cancer treatment not part of the study, except bone-strengthening drugs such as zoledronic acid or denosumab
  • Previous treatment with camizestrant, similar experimental drugs, or fulvestrant
  • Pregnant or breastfeeding
  • Known bad allergic reactions to camizestrant or similar drugs, or (for younger women and men who would need it) to LHRH agonists (drugs that lower hormone levels)

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 130 Years
Who
All
Number of participants
4,300
Started
2023-03-31
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for breast cancer, early breast cancer
  • • Phase3 - 4,300 participants
  • • 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

Who can take part?

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

Where?

  • • Brighton - Research Site
  • • Burton-on-Trent - Research Site
  • • Cambridge - Research Site
  • • Derby - Research Site
  • • +11 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 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.

More detail

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 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. The eligible patients must have intermediate or high risk of recurrence, as defined by specified clinical and biologic criteria. Prior use of CDK4/6 inhibitors is permitted. 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

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

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 high or intermediate risk of...
  • ✓Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast...
  • ✓Completed at least 2 years but no more than 5 years (+3 months) of after surgery ET (+/- CDK4/6 inhibitor)
  • ✓activity scale (ECOG) performance status of ≤ 1

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 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

Where Is This Study? (15 UK sites)

Research Site

Brighton BN2 5BE, United Kingdom

ACTIVE_NOT_RECRUITING

Research Site

Burton-on-Trent DE13 0RB, United Kingdom

ACTIVE_NOT_RECRUITING

Research Site

Cambridge CB2 0QQ, United Kingdom

ACTIVE_NOT_RECRUITING

Research Site

Derby DE22 3NE, United Kingdom

ACTIVE_NOT_RECRUITING

Research Site

Edinburgh EH4 2XU, United Kingdom

ACTIVE_NOT_RECRUITING

Research Site

Guildford, United Kingdom

WITHDRAWN

Research Site

Ipswich IP4 5PD, United Kingdom

ACTIVE_NOT_RECRUITING

Research Site

Keighley BD20 6TD, United Kingdom

WITHDRAWN

Research Site

London SE1 9RT, United Kingdom

TERMINATED

Research Site

London SW3 6JJ, United Kingdom

ACTIVE_NOT_RECRUITING

Research Site

Manchester M20 4BX, United Kingdom

ACTIVE_NOT_RECRUITING

Research Site

Oxford OX3 7LJ, United Kingdom

ACTIVE_NOT_RECRUITING

Research Site

Peterborough PE3 9GZ, United Kingdom

WITHDRAWN

Research Site

Stoke-on-Trent ST4 6QG, United Kingdom

WITHDRAWN

Research Site

Sutton SM2 5PT, United Kingdom

ACTIVE_NOT_RECRUITING

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com

AstraZeneca Breast Cancer Study Locator Service

Sponsor contact

CONTACT

1-877-400-4655 az-bcsl@careboxhealth.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08