Ongoing Clinical Trials for Hot Flush
There are currently 2 ongoing clinical trials investigating treatments for hot flashes in women with hormone receptor-positive breast cancer or at high risk for developing it. These trials are testing non-hormonal medications called fezolinetant and elinzanetant, which aim to reduce the frequency and severity of hot flashes experienced as a side effect of hormone therapy for breast cancer.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Denmark
- Finland
- France
- Germany
- Hungary
- Ireland
- Italy
- Netherlands
- Poland
- Portugal
- Romania
- Spain
Study of Fezolinetant for Hot Flashes in Women with Hormone Receptor-Positive Breast Cancer Receiving Hormone Therapy
This trial is designed for women with hormone receptor-positive breast cancer who experience moderate to severe hot flashes while receiving hormone therapy. The study tests whether fezolinetant, a medication taken once daily, can effectively reduce both the frequency and severity of these symptoms.
Main inclusion criteria:
- Female participants at least 18 years of age
- Confirmed diagnosis of stage 0-3 hormone receptor-positive breast cancer
- Currently receiving stable hormone therapy (tamoxifen or aromatase inhibitors) for at least 4 months and planning to continue throughout the study
- Experiencing an average of at least 7 moderate to severe hot flashes per day, recorded over at least 7 out of 10 days
- Able to carry out all normal activities or light work
- Life expectancy of at least 12 months
- Negative tests for hepatitis B, hepatitis C, and HIV
Main exclusion criteria:
- Age below 18 or above 65 years
- Male patients
- Stage 4 breast cancer
- Pregnant or breastfeeding women
- Known allergies to fezolinetant
- Severe liver or kidney disease
- Uncontrolled high blood pressure
- Significant psychiatric disorders
- Participation in other clinical trials
Focus of the trial: The study will investigate whether fezolinetant 45 mg taken once daily can effectively reduce both the frequency and severity of hot flashes compared to placebo. Participants will be randomly assigned to receive either fezolinetant or a placebo tablet for up to 52 weeks. Throughout the study, participants will record their hot flash symptoms daily in an electronic diary. The trial will evaluate changes at 4, 12, and 24 weeks, assessing not only hot flash frequency and severity but also quality of life and sleep patterns.
Investigational drug: Fezolinetant is a non-hormonal medication that works by targeting and blocking neurokinin-3 receptors in the brain’s temperature control center. This helps regulate body temperature and reduce hot flashes. The medication is administered as a 45 mg film-coated tablet taken once daily. This non-hormonal approach is particularly important for breast cancer patients who cannot use traditional hormone-based treatments for hot flashes.
Study on Elinzanetant for Treating Hot Flashes in Women with or at High Risk for Hormone-Receptor Positive Breast Cancer
This clinical trial focuses on studying elinzanetant for treating hot flashes in women who either have hormone-receptor positive breast cancer or are at high risk for developing it. The study aims to compare how well elinzanetant works in reducing these symptoms compared to a placebo.
Main inclusion criteria:
- Females aged 18 to 70 years old
- Experiencing hot flashes caused by hormone therapy expected to continue for the duration of the study
- Receiving tamoxifen or aromatase inhibitors, with or without gonadotropin-releasing hormone analogues
- Either a personal history of hormone-receptor positive breast cancer or high risk for developing breast cancer
- Completed a Hot Flash Daily Diary for at least 11 days during the two weeks before the baseline visit
- Recorded at least 35 moderate to severe hot flashes over the last 7 days of diary completion
- Use of appropriate contraception (if applicable)
Main exclusion criteria:
- Not experiencing hot flashes due to breast cancer treatment
- Not receiving hormone therapy to prevent cancer from returning
- Do not have, or are not at high risk for, hormone-receptor positive breast cancer
- Male participants
Focus of the trial: The study will monitor changes in the frequency and severity of hot flashes over time, with primary evaluation points at Week 4 and Week 12. Participants will be randomly assigned to receive either elinzanetant or a placebo in the form of soft capsules taken by mouth. The trial will last for 52 weeks, with an optional extension for an additional two years. Throughout the study, participants will continue to record their symptoms in a daily diary, and researchers will assess effects on sleep quality and overall quality of life.
Investigational drug: Elinzanetant is administered as 60 mg soft capsules taken orally. It works by modulating neurokinin receptors, which are involved in regulating body temperature and other functions. As a neurokinin receptor antagonist, it aims to alleviate symptoms associated with hormonal changes. The medication is currently in the investigational stage, with ongoing research to determine its safety and effectiveness for treating hot flashes caused by hormone therapy.
Summary
Both ongoing clinical trials address an important quality-of-life issue for women undergoing hormone therapy for breast cancer. Hot flashes are a common and often distressing side effect of these treatments, and these studies investigate non-hormonal solutions that may provide relief without interfering with cancer treatment.
The trials are widely distributed across Europe, with both studies recruiting participants in multiple countries including Germany, France, Italy, Spain, Poland, and Hungary. This broad geographic distribution ensures diverse patient populations and increases accessibility for women who may benefit from these treatments.
Both fezolinetant and elinzanetant belong to the class of neurokinin receptor antagonists, representing a similar approach to managing hot flashes through non-hormonal mechanisms. This is particularly important for breast cancer patients, as traditional hormone-based treatments for hot flashes may not be appropriate given their cancer diagnosis. The trials require participants to experience a significant number of moderate to severe hot flashes, ensuring that the study population truly needs symptom relief and that any improvements can be meaningfully measured.