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Study Comparing Elacestrant and Standard Endocrine Therapy for Patients with Early Breast Cancer at High Risk of Recurrence

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of breast cancer known as node-positive, estrogen receptor-positive, HER2-negative early breast cancer, which has a high risk of coming back after treatment. The study is comparing a new treatment called Elacestrant with standard hormone therapies. Elacestrant is a medication taken by mouth in the form of a tablet. The standard hormone therapies being compared include Letrozole, Exemestane, Anastrozole, and Tamoxifen, which are also taken as tablets.

The purpose of the study is to see how well Elacestrant works compared to these standard treatments in preventing the return of breast cancer. Participants in the study will be randomly assigned to receive either Elacestrant or one of the standard hormone therapies. The study will last for a period of up to 60 months, during which participants will take their assigned medication daily. Throughout the study, participants will have regular check-ups to monitor their health and any changes in their condition.

The study will also look at how the treatments affect the participants' quality of life, including any side effects they may experience. This will help researchers understand the overall impact of Elacestrant compared to the standard treatments. The information gathered from this study will contribute to better understanding and potentially improving treatment options for people with this type of breast cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Upon joining the study, participants are randomly assigned to one of two groups. One group receives elacestrant, while the other group receives standard endocrine therapy. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment.

  2. Step 2

    Treatment administration

    Participants in the elacestrant group take the medication orally. The specific dosage and frequency are determined by the study protocol and communicated to participants by the study team.

    Participants in the standard endocrine therapy group receive one of the following medications: letrozole, exemestane, anastrozole, or tamoxifen. These medications are also taken orally, and the dosage and frequency are specified by the study protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the study, participants undergo regular monitoring to assess the effectiveness and safety of the treatment. This includes checking for any signs of cancer recurrence and monitoring for any side effects.

    Participants may be required to complete questionnaires to evaluate their quality of life and any symptoms related to endocrine therapy. These assessments occur at 6 and 12 months, and then annually.

  4. Step 4

    Follow-up

    Participants continue to be monitored for a specified period, even after completing the treatment phase. This follow-up period helps to gather long-term data on the treatment's effectiveness and any potential late-onset side effects.

Who can join the trial?

8 criteria

  • The patient must have a type of breast cancer called node-positive, estrogen receptor-positive, HER2-negative early breast cancer. This means the cancer has spread to nearby lymph nodes, has receptors for estrogen, and does not have a protein called HER2.
  • The patient should have a high risk of the cancer coming back.
  • The patient must have had their cancer confirmed by a test called immunohistochemistry (IHC), which checks for specific proteins in cancer cells.
  • The patient should have had surgery to remove the cancer and should not have any signs of the cancer coming back or spreading to other parts of the body.
  • The patient must have received endocrine therapy (treatment that blocks hormones) for at least 24 months but not more than 60 months. This could include medications like aromatase inhibitors (AIs) or tamoxifen.
  • If the patient has taken other treatments like CDK4/6 inhibitors or PARP inhibitors, they must have already finished or stopped these treatments.
  • The study is open to both female and male patients.
  • The study includes patients who are considered part of a vulnerable population, which means they might need extra protection or care.

Who cannot join the trial?

8 criteria

  • Patients who do not have node-positive breast cancer. This means the cancer has not spread to the lymph nodes.
  • Patients who do not have estrogen receptor-positive breast cancer. This means the cancer does not grow in response to the hormone estrogen.
  • Patients who have HER2-positive breast cancer. This means the cancer has too much of a protein called HER2, which promotes the growth of cancer cells.
  • Patients who do not have a high risk of recurrence. This means the cancer is not likely to come back after treatment.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are not female or male, as both genders are included in the study.
  • Patients who are not considered part of a vulnerable population. This refers to groups who may need special protection or consideration in research.
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Investigated drugs

  • Elacestrant

    is a medication being studied for its effectiveness in treating early breast cancer. It is specifically used for patients who have a high risk of the cancer coming back. Elacestrant works by targeting estrogen receptors, which are often involved in the growth of breast cancer cells. This medication is being compared to standard endocrine therapies to see if it can better prevent the cancer from returning.

  • Standard Endocrine Therapy

    refers to the usual treatments given to patients with hormone receptor-positive breast cancer. These therapies typically work by blocking the effects of estrogen, a hormone that can promote the growth of breast cancer cells. The goal of these treatments is to reduce the risk of cancer recurrence and improve survival rates. In this study, standard endocrine therapy serves as a comparison to evaluate the effectiveness of elacestrant.

What is already known about the treatment

Elacestrant – Elacestrant is administered orally and is currently being studied in clinical trials for its effectiveness in treating early breast cancer that is node-positive, estrogen receptor-positive, and HER2-negative, with a high risk of recurrence. It is not yet widely used in standard medical practice but is being evaluated for its potential benefits compared to standard endocrine therapies. The main therapeutic indication for elacestrant is to improve invasive breast cancer-free survival in patients with this specific type of breast cancer. At the molecular level, elacestrant works by selectively degrading estrogen receptors, which are proteins that can promote the growth of breast cancer cells. It is classified pharmacologically as a selective estrogen receptor degrader (SERD).

Investigated diseases

Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence – This type of breast cancer is characterized by the presence of cancer cells in the lymph nodes, indicating that the cancer has started to spread beyond the original tumor site. The cancer cells have receptors for estrogen, meaning they may grow in response to this hormone. It is HER2-negative, which means the cancer cells do not have an excess of the HER2 protein on their surfaces. This type of breast cancer is considered early-stage but has a high risk of coming back after initial treatment. The progression involves the potential for the cancer to return locally, regionally, or at distant sites in the body. The risk of recurrence is a significant concern, and monitoring is essential to manage and understand the disease's progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515445-42-00Protocol codeSTML-ELA-0422Estimated enrolment4 584 patientsSponsorStemline Therapeutics Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).