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.
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 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
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
