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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (15 UK sites)
Research Site
Brighton BN2 5BE, United Kingdom
Research Site
Burton-on-Trent DE13 0RB, United Kingdom
Research Site
Cambridge CB2 0QQ, United Kingdom
Research Site
Derby DE22 3NE, United Kingdom
Research Site
Edinburgh EH4 2XU, United Kingdom
Research Site
Guildford, United Kingdom
Research Site
Ipswich IP4 5PD, United Kingdom
Research Site
Keighley BD20 6TD, United Kingdom
Research Site
London SE1 9RT, United Kingdom
Research Site
London SW3 6JJ, United Kingdom
Research Site
Manchester M20 4BX, United Kingdom
Research Site
Oxford OX3 7LJ, United Kingdom
Research Site
Peterborough PE3 9GZ, United Kingdom
Research Site
Stoke-on-Trent ST4 6QG, United Kingdom
Research Site
Sutton SM2 5PT, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
AstraZeneca Breast Cancer Study Locator Service
Sponsor contactCONTACT
