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RecruitingLast updated: 27 February 2026

ELEGANT: This clinical trial is recruiting people with early breast cancer that is node-positive, ER+, HER2- that has a high risk of recurrence, to evaluate different hormone therapiesElacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study

Trial purpose

Medical clipboardCancer treatment

Tumor type

Breast Cancers Breast

Age

People18+

Trial acronym

ELEGANT

Clinical summary

Summary

The purpose of this study is to evaluate the effectiveness of elacestrant versus standard hormone therapy (also called endocrine therapy) in people with node-positive, oestrogen receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with a high risk of recurrence.

Eligible participants will be randomly allocated to one of two treatment arms.

In Arm 1, participants will receive Elacestrant hormone therapy which will be given once daily as an oral tablet for 5 years.

In Arm 2, participants will receive standard of care hormone therapy that was used in their treatment prior to randomisation, either:

  • AI (anastrozole oral tablets once daily, letrozole oral tablets once daily or exemestane oral tablets once daily); or
  • Tamoxifen oral tablets once daily.

Conditions

This trial is treating people with early breast cancer with a high risk of recurrence after receiving at least 24 months of prior hormone therapy

Eligibility

Inclusion

  • Histopathologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry [IHC]), HER2-negative [IHC = 0 or 1, or (IHC = 2 and in situ hybridization [ISH]-negative)] 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 (ASCO)/College of American Pathologists (CAP) guidelines
  • Participants considered at high risk of recurrence at initial staging
  • Participants who have received at least 24 months but not more than 60 months of endocrine therapy (AIs or tamoxifen) with or without a CDK 4 and CKD 6 inhibitor (CDK4/6i)
  • Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor must have already completed or discontinued these treatments.

Exclusion

  • Participants with inflammatory breast cancer
  • History of any prior (ipsilateral and/or contralateral) invasive breast cancer
  • Participant with history of 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 discontinued adjuvant endocrine therapy more than 6 months prior to randomization

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • Your cancer has not spread to other parts of the body (localised).
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

Stemline Therapeutics, Inc.

Scientific Title

Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study

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