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Looking for participantsPhase3

A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence

Sponsor: Stemline Therapeutics, Inc.

NCT ID: NCT06492616

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
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.

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 and over
  • Who can join: All genders

Biomarkers mentioned

ERHER2not amplifiednode positive

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
Key Inclusion Criteria: * Histopathologically or cytologically confirmed ER+ (≥10% by immunohistochemistry \[IHC\]), HER2- (tumors with an IHC score of 0, 1+, or 2+ with in situ hybridization \[ISH\]-negative \[not amplified\]). ISH-negative without IHC testing will also be eligible on tumor biopsy or final surgical pathology specimen early stage resected invasive breast cancer without evidence of recurrence or distant metastases, per local laboratory, according to the American Society of Clinical Oncology/College of American Pathologists guidelines. * Participants must be node positive (microscopic and macroscopic tumor involvement are allowed) and fulfill one of the following criteria: 1. ≥4 positive axillary lymph nodes or 2. 1-3 positive axillary lymph nodes and 1. Histologic grade 3 disease and/or 2. Tumor size ≥5 centimeters and/or 3. High genomic risk (identified by Oncotype, MammaPrint, EndoPredict, PAM50) * Participants who are currently taking endocrine therapy (aromatase inhibitors or tamoxifen) and have received at least 24 months but not more than 60 months of endocrine therapy at the time of randomization (Cycle 1 Day 1 \[C1D1\]) with or without a CDK 4 and CKD 6 inhibitor (CDK4/6i) and with or without a luteinizing hormone-releasing hormone agonist. * Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase inhibitor must have already completed or discontinued these treatments. Key Exclusion Criteria: * Participants with inflammatory breast cancer. * History of any prior (ipsilateral and/or contralateral) invasive breast cancer. * Participant with history of non-breast malignancy within 3 years of the date of randomization, except for adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix. * Participants who have had more than a 6-month continuous interruption of prior SoC adjuvant endocrine therapy or who are off current adjuvant endocrine therapy more than 6 months prior to randomization. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where Is This Study? (16 UK sites)

Royal Cornwall Hospital (RCH) - Sunrise Centre

Truro TR1 3LJ, United Kingdom

Recruiting
Site contact (verified)
Alastair ThomsonPrincipal Investigator

University Hospitals Sussex NHS Foundation Trust - Royal Sussex County Hospital

Brighton BN2 5BE, United Kingdom

Recruiting
Site contact (verified)
Simon PagePrincipal Investigator

Whittington Health NHS Trust - Whittington Hospital

London N19 5NF, United Kingdom

Recruiting
Site contact (verified)
Emma SpurrellPrincipal Investigator

Cheltenham General Hospital

Cheltenham GL53 7AN, United Kingdom

Recruiting
Site contact (verified)
Jessica BaileyPrincipal Investigator

Mount Vernon Cancer Centre - Main Site

Northwood HA6 2RN, United Kingdom

Recruiting
Site contact (verified)
Stephanie SutherlandPrincipal Investigator

Blackpool Victoria Hospital

Blackpool FY3 8NR, United Kingdom

Recruiting
Site contact (verified)
Pavel BezecnyPrincipal Investigator

Royal Preston Hospital

Preston PR2 9HT, United Kingdom

Recruiting
Site contact (verified)
Martin HoggPrincipal Investigator

University College London Hospitals

London NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Diego OttavianiPrincipal Investigator

The Royal Marsden NHS Foundation Trust - The Royal Marsden Hospital Fulham Road

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Emma KippsPrincipal Investigator

St John's Hospital - NHS Lothian

Livingston EH54 6PP, United Kingdom

Recruiting
Site contact (verified)
David CameronPrincipal Investigator

Musgrove Park Hospital

Taunton TA1 5DA, United Kingdom

Recruiting
Site contact (verified)
Saiqa SpensleyPrincipal Investigator

The Royal Marsden NHS Foundation Trust - The Royal Marsden Sutton

Sutton SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Emma KippsPrincipal Investigator

Western General Hospital

Edinburgh EH4 2XU, United Kingdom

Recruiting
Site contact (verified)
David CameronPrincipal Investigator

Leeds Cancer Centre

Leeds LS9 7TF, United Kingdom

Recruiting
Site contact (verified)
David JacksonPrincipal Investigator

St Bartholomew's Hospital

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Peter SchmidPrincipal Investigator

Maidstone Hospital Kent Oncology Centre

Maidstone ME16 9QQ, United Kingdom

Recruiting
Site contact (verified)
Catherine Harper-WynnePrincipal Investigator

How to Get in Touch

Stemline Trials

Sponsor contact

CONTACT

1-877-332-7961 clinicaltrials@menarinistemline.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09