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
- Elacestrant (drug), Anastrozole (drug), Letrozole (drug), Exemestane (drug)
- How long the study runs
- Study runs about 97 months (dates as stated)
- About the drug or intervention
- Elacestrant — drug: Administered as oral tablets · Anastrozole — drug: Administered as oral tablets · Letrozole — drug: Administered as oral tablets · Exemestane — drug: Administered as oral tablets · Tamoxifen — drug: Administered as oral tablets
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 4,220
- Started
- 2024-09-27
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for breast cancer
- • Phase3 - 4,220 participants
- • The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with breast cancer
Where?
- • Truro - Royal Cornwall Hospital (RCH) - Sunrise Centre
- • Brighton - University Hospitals Sussex NHS Foundation Trust - Royal Sussex County Hospital
- • London - Whittington Health NHS Trust - Whittington Hospital
- • Cheltenham - Cheltenham General Hospital
- • +12 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.
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 and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ already completed or discontinued these treatments
What the study is looking for
- ✓Participants must be node positive (microscopic and macroscopic tumor involvement are allowed) and fulfill one of...
- ✓≥4 positive axillary lymph nodes or
- ✓1-3 positive axillary lymph nodes and
- ✓Histologic grade 3 disease and/or
- ✓Tumor size ≥5 centimeters and/or
Who cannot take part
- ✗Participants with inflammatory breast cancer.
- ✗History of any prior (ipsilateral and/or contralateral) invasive breast cancer.
- ✗Note: Other protocol defined Inclusion/Exclusion criteria may apply.
See the full criteria
Where Is This Study? (16 UK sites)
Royal Cornwall Hospital (RCH) - Sunrise Centre
Truro TR1 3LJ, United Kingdom
University Hospitals Sussex NHS Foundation Trust - Royal Sussex County Hospital
Brighton BN2 5BE, United Kingdom
Whittington Health NHS Trust - Whittington Hospital
London N19 5NF, United Kingdom
Cheltenham General Hospital
Cheltenham GL53 7AN, United Kingdom
Mount Vernon Cancer Centre - Main Site
Northwood HA6 2RN, United Kingdom
Blackpool Victoria Hospital
Blackpool FY3 8NR, United Kingdom
Royal Preston Hospital
Preston PR2 9HT, United Kingdom
University College London Hospitals
London NW1 2PG, United Kingdom
The Royal Marsden NHS Foundation Trust - The Royal Marsden Hospital Fulham Road
London SW3 6JJ, United Kingdom
St John's Hospital - NHS Lothian
Livingston EH54 6PP, United Kingdom
Musgrove Park Hospital
Taunton TA1 5DA, United Kingdom
The Royal Marsden NHS Foundation Trust - The Royal Marsden Sutton
Sutton SM2 5PT, United Kingdom
Western General Hospital
Edinburgh EH4 2XU, United Kingdom
Leeds Cancer Centre
Leeds LS9 7TF, United Kingdom
St Bartholomew's Hospital
London EC1A 7BE, United Kingdom
Maidstone Hospital Kent Oncology Centre
Maidstone ME16 9QQ, United Kingdom
How to Get in Touch
Stemline Trials
Sponsor contactCONTACT
