This study focuses on women with hormone receptor-positive breast cancer who experience moderate to severe vasomotor symptoms (hot flashes) while receiving hormone therapy. These hot flashes can significantly impact daily life and occur as a side effect of breast cancer treatment. The study will test a medication called fezolinetant, which is being investigated to help reduce these symptoms.
The purpose of the study is to determine if fezolinetant 45 mg taken once daily can effectively reduce both the frequency and severity of hot flashes compared to placebo in women undergoing breast cancer hormone therapy. During the study, participants will take either fezolinetant as a film-coated tablet or a matching placebo tablet daily for up to 52 weeks.
The medication will be given to women who are currently receiving stable maintenance adjuvant endocrine therapy (hormone therapy) such as tamoxifen or aromatase inhibitors. Throughout the study, participants will need to record their hot flash symptoms in an electronic diary. The study will monitor how well the treatment works and any potential side effects that may occur.
1Initial participation phase
You will be assigned randomly to receive either fezolinetant 45 mg tablets or placebo tablets to be taken once daily
You must continue your current hormone therapy (tamoxifen or aromatase inhibitors) throughout the study without changes
2First month evaluation
At week 4, your hot flashes will be evaluated for frequency and severity
You will complete questionnaires about your quality of life and sleep patterns
Your overall impression of changes in symptoms will be recorded
3Three-month evaluation
At week 12, another evaluation of hot flashes frequency and severity will be conducted
Additional quality of life and sleep assessments will be performed
Your blood samples will be analyzed to measure medication levels
4Six-month evaluation
At week 24, final assessments of hot flash frequency and severity will be completed
Final quality of life and sleep questionnaires will be administered
Overall safety and effectiveness of the treatment will be evaluated
5Ongoing monitoring
Throughout the study, you will need to record your hot flash symptoms daily in an electronic diary
Regular safety assessments including vital signs and laboratory tests will be conducted
Any side effects or health changes will be monitored and documented
Who Can Join the Study?
Must be born female and at least 18 years of age when signing the consent form
Must have a history of stage 0-3 hormone receptor-positive breast cancer (HR+), with proper documentation
Must be on stable maintenance therapy for breast cancer (using tamoxifen or aromatase inhibitors) for at least 4 months and plan to continue throughout the study without changes
Must experience an average of at least 7 moderate to severe hot flashes per day (recorded over at least 7 out of 10 days before starting the study)
Must have an ECOG score of 0 or 1 (meaning able to carry out all normal activities or light work)
Must have a life expectancy of at least 12 months
Must test negative for hepatitis B, hepatitis C, and HIV
Who Cannot Join the Study?
Age below 18 or above 65 years
Male patients (study is for females only)
Patients who do not have a confirmed diagnosis of hormone receptor-positive breast cancer (stages 0-3)
Patients not experiencing moderate to severe vasomotor symptoms (hot flashes and night sweats)
Patients not currently receiving adjuvant endocrine therapy (hormone treatment after primary cancer therapy)
Patients with breast cancer stage 4 (advanced/metastatic)
Patients not experiencing at least 7 moderate to severe hot flashes per day
Pregnant or breastfeeding women
Patients participating in other clinical trials
Patients with known allergies or sensitivity to the study medication (fezolinetant)
Fezolinetant is a medication being studied for treating moderate to severe hot flashes (vasomotor symptoms) in women who have hormone receptor-positive breast cancer and are receiving endocrine therapy. It works by targeting the brain chemicals involved in regulating body temperature.
Endocrine therapy refers to treatments that lower or block hormones in the body to treat hormone receptor-positive breast cancer. This is a standard treatment that participants are already receiving as part of their cancer care.
Vasomotor Symptoms (VMS) – A condition characterized by sudden feelings of warmth (hot flashes) and sweating, particularly in the upper body, face, and chest. These symptoms often occur during menopause or as a side effect of certain medical treatments. Episodes can vary in frequency and intensity, lasting from a few seconds to several minutes. VMS can be accompanied by heart palpitations, anxiety, and reddening of the skin. The symptoms can disrupt sleep patterns and daily activities, affecting overall quality of life.
Breast Cancer (Hormone Receptor-Positive) – A type of breast cancer where cancer cells grow in response to hormones estrogen and/or progesterone. This cancer begins when abnormal cells in breast tissue start growing uncontrollably. The presence of hormone receptors on cancer cells means that the tumor’s growth is influenced by hormones. It typically develops slowly and can occur in different parts of the breast. This type of breast cancer is the most common form of breast cancer.
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