In short
This article provides information about current clinical research studying treatments for autonomic nervous system imbalance, specifically focusing on vasomotor symptoms such as hot flashes in women undergoing breast cancer treatment. Currently, there is 1 ongoing clinical trial investigating new treatment options for managing these symptoms across multiple countries in Europe.
Clinical trial locations
- Austria
- Belgium
- Finland
- France
- Germany
- Hungary
- Ireland
- Italy
- Poland
- Portugal
- Romania
- Spain
Study on Elinzanetant for Treating Hot Flashes in Women with or at High Risk for Hormone-Receptor Positive Breast Cancer
This clinical trial is investigating whether a medication called elinzanetant can help women manage hot flashes caused by hormone therapy for breast cancer. Hot flashes are sudden feelings of warmth, often accompanied by sweating, which can significantly affect daily life and sleep quality. These symptoms are common in women receiving adjuvant endocrine therapy, a treatment given to prevent breast cancer from returning.
Main focus: The study aims to determine how effective and safe elinzanetant is at reducing the frequency and severity of hot flashes over 52 weeks, with an optional extension for up to two additional years. Researchers will compare results between women taking elinzanetant and those receiving a placebo, an inactive substance with no medication. The study will also examine how the treatment affects sleep quality and overall quality of life.
Who can participate:
- Women aged 18 to 70 years
- Currently experiencing hot flashes caused by breast cancer hormone therapy, including tamoxifen or aromatase inhibitors, with or without hormone-regulating medicines
- Women with a personal history of hormone-receptor positive breast cancer or those at high risk of developing this type of cancer
- Must have experienced at least 35 moderate to severe hot flashes over a 7-day period before joining the study
- Must be willing to complete a daily diary tracking hot flashes for at least 11 days before the baseline visit
- Women of childbearing potential must use appropriate contraception methods
Who cannot participate:
- Women not experiencing hot flashes related to their breast cancer treatment
- Women not currently receiving adjuvant endocrine therapy
- Women who do not have or are not at high risk for hormone-receptor positive breast cancer
- Men are not eligible for this study
Investigational drug: Elinzanetant is a medication classified as a neurokinin receptor antagonist. It works by affecting special receptors in the body that help regulate body temperature and other functions. Participants will take 60 mg soft capsules by mouth. The medication is still being studied to determine its safety and effectiveness for managing vasomotor symptoms.
The study follows participants through several phases, beginning with eligibility confirmation and baseline assessment using a Hot Flash Daily Diary. After being randomly assigned to receive either elinzanetant or placebo, participants are evaluated at weeks 4 and 12 for changes in the frequency of moderate to severe hot flashes. Extended evaluations continue to monitor severity and quality of life measures, with long-term follow-up extending up to 52 weeks or potentially longer.
Summary
Currently, there is one clinical trial addressing autonomic nervous system imbalance related to vasomotor symptoms in women with breast cancer. This trial is being conducted across 12 European countries, including Germany, Finland, Belgium, Poland, Hungary, Romania, Portugal, Ireland, Italy, Spain, France, and Austria, making it widely accessible to eligible participants across Europe.
The study focuses specifically on elinzanetant, a neurokinin receptor antagonist being investigated for its potential to reduce hot flashes caused by breast cancer hormone therapy. This represents an important area of research, as vasomotor symptoms can significantly impact the quality of life for women undergoing cancer treatment. The trial's design, which includes comparison to placebo and long-term follow-up, will help researchers better understand both the short-term and long-term effects of this investigational treatment.
