A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy
This study is for women with breast cancer who are experiencing moderate to severe hot flashes due to their hormone therapy. Hormone therapy is a common treatment for breast cancer, but it can cause uncomfortable hot flashes. While HRT (hormone replacement therapy) often helps with hot flashes during menopause, it's not suitable for women undergoing breast cancer treatment. Fezolinetant is another medication that treats hot flashes. We want to find out if fezolinetant can successfully reduce the number and severity of hot flashes for these women, compared to a placebo (a tablet with no medicine). Participants will take a tablet daily for a year and track their hot flashes on a device.
At a glance
What is this study about?
For women undergoing treatment for breast cancer, hormone therapy is a really important way to help prevent the cancer from returning. However, a common and often difficult side effect of this treatment is experiencing hot flashes. These can affect your daily life and comfort.
Usually, for women going through menopause, hormone replacement therapy (HRT) is a good option to help with hot flashes. But for women with breast cancer who are on hormone therapy, HRT isn't a safe choice. This means we need to find other ways to help manage these hot flashes. Fezolinetant is a medication that has already shown promise in reducing hot flashes for women in menopause, and because the hot flashes happen in a similar way, we think it might also help women with breast cancer.
This study aims to investigate whether fezolinetant can effectively reduce the number and severity of hot flashes for women who are having hormone therapy for breast cancer. We will compare it against a 'placebo', which looks exactly like the actual medicine but doesn't contain any active ingredients. This helps us to truly understand if it's the fezolinetant making the difference.
Key takeaways
- The study helps women with breast cancer experiencing hot flashes from hormone therapy.
- It tests a new treatment, fezolinetant, against a dummy pill (placebo).
- You would take a tablet daily for one year and track your hot flashes.
- Participation lasts about two years, with clinic visits and follow-up calls.
- The study is 'double-blinded', meaning treatment assignments are secret.
- You can stop participating at any time if you change your mind.
Who may be eligible?
This study is looking for women aged 18 or older who are experiencing moderate to severe hot flashes due to their breast cancer hormone therapy. To be eligible, you should be having at least 7 moderate or severe hot flashes each day.
Your breast cancer should be hormone receptor positive and fall into stages 0 to 3+. You must also be currently receiving stable hormone therapy for your breast cancer, such as Tamoxifen or an aromatase inhibitor, and plan to continue it throughout the study.
There are also some general health requirements, including having a good general fitness level and an expected life span of at least 12 months. You must not be pregnant, breastfeeding, or planning to become pregnant during the study. If you can get pregnant, you'll need to use reliable contraception.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you a woman aged 18 or older?
- Do you have hormone receptor-positive breast cancer (stage 0-3+)?
- Are you currently on stable hormone therapy for breast cancer?
- Do you experience an average of 7 or more moderate to severe hot flashes daily?
- Are you not pregnant or breastfeeding, and willing to use contraception if needed?
What does participation involve?
If you decide to take part, you will be in the study for about two years in total. For the first 52 weeks (one year), you will take one tablet every day. This tablet will either be fezolinetant or a placebo (a dummy pill with no medicine), chosen at random. Neither you nor your study doctor will know which one you are taking – this is called 'double-blinded'.
You'll be given a special electronic device, like a small tablet or your own smartphone if it's compatible, to track your hot flashes daily. You'll also use another device to answer questions about how hot flashes affect your life. Throughout the year of taking tablets, you will need to visit your study clinic about every four weeks for a health check-up. After you stop taking the tablets, there will be one last clinic visit about three weeks later, followed by two phone calls to check on your health. This helps the study team understand the full effects of the treatment and how you are doing.
Potential risks and benefits
Locations (110)
- Site CA15019Verified postcodeSarnia, Canada
- Site CA15016Verified postcodeSault Ste. Marie, Canada
- Site CA15002Verified postcodeMontreal, Canada
- Site CA15001Verified postcodeQuébec, Canada
- Site CA15004Verified postcodeQuébec, Canada
- Site CA15003Verified postcodeSherbrooke, Canada
- Site CA15020Verified postcodeVictoriaville, Canada
- Site CA15007Verified postcodeTrois-Rivières, Canada
- Site CZ42006Verified postcodeČeské Budějovice, Czechia
- Site CZ42003Verified postcodeHořovice, Czechia
- Site CZ42002Verified postcodeHradec Králové, Czechia
- Site CZ42011Verified postcodeNový Jičín, Czechia
Common questions
What is hormone therapy for breast cancer?
Hormone therapy is a treatment that helps to stop breast cancer cells from growing by blocking hormones they need. It's often used after other treatments like surgery or chemotherapy.
Why can't I have HRT for hot flashes if I have breast cancer?
HRT contains hormones that could potentially encourage some types of breast cancer to grow, so it's not usually a safe option for women who have had breast cancer.
What is a placebo?
A placebo is a 'dummy' tablet that looks exactly like the study drug but contains no active medicine. It helps researchers understand if the study drug is truly having an effect.
Will I know if I'm taking the real drug or the placebo?
No, this study is 'double-blinded', meaning neither you nor your study doctor will know whether you are taking fezolinetant or the placebo.
How long will I need to be in the study?
You will be in the study for about two years in total. You'll take tablets daily for one year, with follow-up appointments and calls after that.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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