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Study on Amcenestrant Alone and with Drug Combination for Postmenopausal Women with Estrogen Receptor-Positive Advanced Breast Cancer

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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 treatments for advanced breast cancer in postmenopausal women. The study involves a medication called amcenestrant (also known by its code name SAR439859), which is being tested both on its own and in combination with other cancer treatments. These additional treatments include palbociclib (marketed as IBRANCE), abemaciclib (marketed as Verzenios), everolimus, and alpelisib. The purpose of the study is to evaluate the safety and effectiveness of these treatments in women whose cancer is positive for estrogen receptors (ER-positive) and negative for HER2 receptors.

The study will begin with a phase where the safety of different doses of amcenestrant is assessed, both alone and in combination with the other medications. This phase will help determine the most suitable dose for further testing. Following this, the study will expand to evaluate how well the treatment works in reducing cancer size or slowing its growth. Participants will take the medications orally, and the study will monitor their response to the treatment over time.

Throughout the study, researchers will keep track of any side effects experienced by participants and measure how the cancer responds to the treatment. The study aims to find the best dose of amcenestrant and its combinations that can be safely used to treat advanced breast cancer. The trial is expected to continue until the end of 2027, providing valuable information on the potential benefits and risks of these treatments for women with this type of cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, you will have an initial visit with the research team. During this visit, your medical history will be reviewed, and you will undergo a physical examination. Blood tests and imaging studies may be conducted to assess your current health status and the extent of your breast cancer.

  2. Step 2

    Dose escalation phase

    In this phase, you will receive the medication amcenestrant as a single agent. The purpose is to determine the safest and most effective dose. You will take the medication orally, and the research team will monitor you closely for any side effects.

    If you are part of a combination therapy group, you may also receive palbociclib or abemaciclib alongside amcenestrant. These medications are also taken orally. The research team will provide specific instructions on dosage and frequency.

  3. Step 3

    Safety run-in phase

    During this phase, the focus is on confirming the recommended dose of amcenestrant when combined with another medication called alpelisib. You will continue to take the medications orally, and your health will be monitored to ensure the combination is safe.

  4. Step 4

    Dose expansion phase

    In this phase, the effectiveness of amcenestrant as a single agent and in combination with other medications will be evaluated. You may receive additional medications such as everolimus or abemaciclib along with amcenestrant. The research team will assess the response of your cancer to the treatment and monitor for any side effects.

  5. Step 5

    Regular follow-up visits

    Throughout the trial, you will have regular follow-up visits with the research team. These visits are important for monitoring your health, managing any side effects, and assessing the effectiveness of the treatment. Blood tests, imaging studies, and other assessments may be conducted during these visits.

  6. Step 6

    End of trial

    At the end of the trial, a final assessment will be conducted. This will include a review of your overall health, the response of your cancer to the treatment, and any side effects experienced. The research team will discuss the results with you and provide guidance on future care options.

Who can join the trial?

7 criteria

  • Participants must be postmenopausal women. This means women who have stopped having menstrual periods for at least a year.
  • Must have a histological diagnosis of breast adenocarcinoma. This means a type of breast cancer confirmed by examining tissue under a microscope.
  • Must have locally advanced or metastatic disease. This means the cancer has spread beyond the breast to nearby areas or other parts of the body.
  • The cancer must be positive for Estrogen Receptors (ER+) and negative for HER2 (HER2-). This means the cancer grows in response to estrogen but does not have too much of a protein called HER2.
  • Participants must have been previously treated with at least 6 months of endocrine therapy for advanced disease. Endocrine therapy is a treatment that blocks or lowers the amount of hormones in the body to slow down or stop the growth of cancer.
  • Participants may have been treated with chemotherapy for advanced disease, but with limits on the number of previous treatments. Chemotherapy is a type of cancer treatment that uses drugs to kill cancer cells.
  • Must have a measurable lesion. This means there is a tumor or area of cancer that can be measured in size.

Who cannot join the trial?

2 criteria

  • Patients who are male cannot participate in the study.
  • Patients who are part of a vulnerable population cannot participate. This means groups of people who might need special protection or care.
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Investigated drugs

  • Amcenestrant

    is a medication being studied for its potential to treat advanced breast cancer in postmenopausal women. It works by targeting and blocking estrogen receptors, which can help slow down or stop the growth of cancer cells that rely on estrogen to grow. In this trial, amcenestrant is being tested both on its own and in combination with other cancer treatments to see how effective and safe it is.

  • Palbociclib

    is a medication used in combination with other treatments to help manage advanced breast cancer. It works by inhibiting certain proteins that are involved in cell division, which can help slow down the growth of cancer cells. In this trial, palbociclib is combined with amcenestrant to evaluate their combined effect on cancer treatment.

  • Everolimus

    is a medication that helps treat certain types of cancer by interfering with cancer cell growth and spread. It works by blocking a specific protein that cancer cells need to grow. In this study, everolimus is used in combination with amcenestrant to assess their joint effectiveness in treating breast cancer.

  • Abemaciclib

    is a cancer treatment that targets proteins involved in cell division, helping to slow down the growth of cancer cells. It is used in combination with other medications to treat advanced breast cancer. In this trial, abemaciclib is combined with amcenestrant to determine their effectiveness together.

  • Alpelisib

    is a medication that targets a specific pathway in cancer cells, which can help stop their growth. It is used in combination with other treatments for certain types of breast cancer. In this study, alpelisib is combined with amcenestrant to confirm the best dose and evaluate their combined safety and effectiveness.

What is already known about the treatment

Amcenestrant – Amcenestrant is an oral medication currently being studied for its potential use in treating advanced breast cancer in postmenopausal women. It is in the clinical trial phase, where researchers are evaluating its safety and effectiveness, both as a standalone treatment and in combination with other cancer therapies like palbociclib, alpelisib, everolimus, and abemaciclib. The main therapeutic indication for amcenestrant is estrogen receptor-positive advanced breast cancer. At the molecular level, amcenestrant works by blocking the activity of estrogen receptors, which can help slow down or stop the growth of cancer cells that rely on estrogen. It is classified pharmacologically as a selective estrogen receptor degrader (SERD).

Investigated diseases

Cancer – Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells. It can develop in almost any organ or tissue, such as the lung, colon, breast, skin, bones, or nerve tissue. The progression of cancer involves the transformation of normal cells into malignant ones, which can invade nearby tissues and spread to other parts of the body through the blood and lymph systems. As cancer progresses, it can form tumors, which may interfere with the normal function of the affected organs. The rate of progression varies depending on the type of cancer and its location. Some cancers grow slowly and may not cause symptoms for a long time, while others can grow rapidly and cause significant health issues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-512997-89-00Protocol codeTED14856Estimated enrolment3 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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