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Study on Elinzanetant for Treating Hot Flashes in Women with or at High Risk for Hormone-Receptor Positive Breast Cancer

Fast replyInvestigationalNo placebo
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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 the effectiveness and safety of a medication called elinzanetant for treating hot flashes in women who are either undergoing or at high risk for developing hormone-receptor positive breast cancer. Hot flashes are sudden feelings of warmth, often associated with sweating, that can be caused by certain cancer treatments known as adjuvant endocrine therapy. This study aims to see how well elinzanetant works in reducing these symptoms compared to a placebo, which is a substance with no active medication.

Participants in the study will be randomly assigned to receive either elinzanetant or a placebo. The study will last for 52 weeks, with an option to continue for an additional two years. During this time, participants will take the medication in the form of soft capsules by mouth. The study will monitor changes in the frequency and severity of hot flashes over time, as well as any effects on sleep and quality of life.

The goal of the study is to provide more information about how elinzanetant can help manage hot flashes in women affected by hormone-receptor positive breast cancer treatments. By comparing the results between those taking elinzanetant and those taking a placebo, researchers hope to better understand the potential benefits and safety of this treatment option.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical history, and current symptoms.

    Participants must be women aged 18 to 70, experiencing hot flashes due to endocrine therapy, and have a history or high risk of hormone-receptor positive breast cancer.

  2. Step 2

    Baseline assessment

    Participants complete a Hot Flash Daily Diary (HFDD) for at least 11 days in the two weeks before the baseline visit.

    At least 35 moderate to severe hot flashes must be recorded over the last 7 days of diary completion.

  3. Step 3

    Treatment phase

    Participants are randomly assigned to receive either the study medication, elinzanetant, or a placebo.

    The medication is administered in the form of 60 mg soft capsules taken orally.

  4. Step 4

    Initial evaluation

    The primary focus is on the change in frequency of moderate to severe hot flashes from the start of the study to Week 4 and Week 12.

    Participants continue to record their symptoms in the HFDD.

  5. Step 5

    Extended evaluation

    Secondary assessments include changes in the severity of hot flashes and other quality of life measures.

    These assessments occur from baseline to Week 12 and may continue over a longer period if the participant remains in the study.

  6. Step 6

    Long-term follow-up

    The study may extend for up to 52 weeks, with an optional additional 2 years for further observation.

    Participants' health and symptom changes are monitored throughout this period.

Who can join the trial?

7 criteria

  • Females aged 18 to 70 years old at the time of signing the informed consent.
  • Women experiencing vasomotor symptoms (like hot flashes) caused by adjuvant endocrine therapy (a treatment given in addition to the main treatment) that they are expected to use for the duration of the study. This includes:
    • Tamoxifen, with or without the use of gonadotropin-releasing hormone (GnRH) analogues (medicines that affect hormone levels).
    • Aromatase inhibitors, with or without the use of GnRH analogues.
    • Women must have either:
      • A personal history of hormone-receptor positive breast cancer (a type of breast cancer that grows in response to hormones).
      • A high risk for developing breast cancer.
      • Participant has completed the Hot Flash Daily Diary (HFDD) for at least 11 days during the two weeks before the baseline visit and has recorded at least 35 moderate to severe hot flashes (including night-time hot flashes) over the last 7 days that the HFDD was completed.
      • Contraceptive use by women (except for post-menopausal women or Women of Non-Childbearing Potential (WONCBP)) should follow local regulations regarding the methods of contraception for those participating in clinical studies.

Who cannot join the trial?

5 criteria

  • Women who are not experiencing vasomotor symptoms (like hot flashes) due to their breast cancer treatment cannot participate.
  • Women who are not receiving adjuvant endocrine therapy (a treatment to prevent cancer from returning) are excluded.
  • Women who do not have, or are not at high risk for developing, hormone-receptor positive breast cancer (a type of breast cancer that grows in response to hormones) cannot join the study.
  • Men are not eligible to participate in this study.
  • Individuals who are not considered part of a vulnerable population (groups that may need special protection) are excluded.
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Investigated drugs

Elinzanetant is a medication being studied for its ability to treat vasomotor symptoms, such as hot flashes, which are caused by adjuvant endocrine therapy. This therapy is often used in women who have, or are at high risk for developing, hormone-receptor positive breast cancer. The study aims to determine how effective and safe elinzanetant is over a period of 52 weeks, with an optional extension for an additional 2 years.

What is already known about the treatment

Elinzanetant – Elinzanetant is administered orally and is currently being studied in clinical trials for its effectiveness in treating vasomotor symptoms, such as hot flashes, caused by adjuvant endocrine therapy in women with or at high risk for hormone-receptor positive breast cancer. The medication is in the investigational stage, with ongoing research to determine its safety and efficacy. It works by modulating neurokinin receptors, which are involved in the regulation of body temperature and other functions. Elinzanetant is classified as a neurokinin receptor antagonist, aiming to alleviate symptoms associated with hormonal changes.

Investigated diseases

Vasomotor Symptoms – These are symptoms such as hot flashes and night sweats that occur due to changes in blood vessel regulation. They are commonly experienced by women undergoing menopause or those receiving certain hormone therapies. The symptoms can vary in frequency and severity, often causing discomfort and affecting daily activities. In the context of hormone-receptor positive breast cancer, these symptoms may be exacerbated by adjuvant endocrine therapy. The progression involves fluctuations in body temperature and can lead to sleep disturbances and reduced quality of life. Management focuses on alleviating these symptoms to improve overall well-being.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508265-33-00Protocol code21656Estimated enrolment474 patientsSponsorBayer AG

sourced from the EU Clinical Trials Register and site verification

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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).