Active not recruitingPHASE3INTERVENTIONAL

A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer

This study is testing a new medication, elinzanetant, for women experiencing hot flashes. These hot flashes are a common side effect of anti-cancer therapy for hormone-receptor positive breast cancer. Researchers want to find out if elinzanetant is better than a dummy pill (placebo) at reducing these hot flashes and whether it is safe to use. You might be eligible if you are a woman aged 18-70 with hot flashes due to this type of breast cancer treatment. Participation involves taking capsules daily and keeping track of your hot flashes, along with regular health checks. The study aims to improve the quality of life for women undergoing breast cancer treatment.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Bayer

Enrolment target

474

Start

14 Oct 2022

Estimated completion

05 Jun 2028

Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer Hot Flashes

Results

Results from this study

Posted October 2025

Results have been published for this study.

Primary outcome

Mean Change in Frequency of Moderate to Severe Hot Flashes (HF) From Baseline to Week 4 (Assessed by Hot Flash Daily Diary [HFDD])

Participants' assessments of HF were recorded electronically twice daily using the sponsor developed Hot Flash Daily Diary (HFDD). The HFDD was completed in the morning after waking up (morning diary) and each evening at bedtime (evening diary) on the hand-held device. The HFDD items assessed the number of mild, moderate, and severe HF experienced during the day and during the night. Mild HF was defined as a "sensation of heat without sweating", moderate HF was defined as a "sensation of heat with sweating, but able to continue activity", and severe HF was defined as a "sensation of heat with sweating, causing cessation (stopping) of activity". Mean daily frequency is calculated as total number of moderate to severe HF during that week divided by the total number of available days with data during that week.

Full results on the registry

What is this study about?

Many women who are being treated for hormone-receptor positive breast cancer, or are at high risk of developing it, experience hot flashes. These hot flashes are a common and often difficult side effect of the anti-cancer treatments that work by targeting the hormones that can help breast cancer grow. While these treatments are very beneficial, hot flashes can really affect a woman's daily life and sometimes even lead to them stopping their important anti-cancer therapy.

This study is looking at a new medication called elinzanetant. Researchers believe this drug works by blocking certain signals in the body that are thought to cause hot flashes. The main goal is to see if elinzanetant can effectively reduce the number and severity of hot flashes in these women. To do this, some women in the study will receive elinzanetant, while others will receive a placebo – which looks like the real drug but contains no active medicine. This comparison helps doctors understand the true effect of the new drug.

Another very important part of the study is to check the safety of elinzanetant. The research team will carefully monitor all participants for any unexpected health problems while they are taking the study medication. By understanding both how well the drug works and its safety, doctors hope to find a better way to manage hot flashes, potentially improving the quality of life for many women going through breast cancer treatment.

Key takeaways

Tests a new drug (elinzanetant) for hot flashes from breast cancer treatment.
Compares Elinzanetant to a dummy pill (placebo) to check effectiveness and safety.
Aimed at women aged 18-70 with hormone-receptor positive breast cancer or at high risk.
Involves daily capsules, hot flash diaries, and regular health checks.
Participation lasts over a year, with optional longer treatment.
Could improve comfort for women undergoing breast cancer therapy.

Who may be eligible?

This study is looking for women aged 18 to 70 years old. You should be experiencing hot flashes because of your hormone therapy for breast cancer. This includes treatments like Tamoxifen or Aromatase inhibitors, which you expect to continue taking throughout the study.

You also need to have either a history of hormone-receptor positive breast cancer, or be considered at high risk for developing it. To make sure your hot flashes are frequent enough for the study, you'll need to have recorded at least 35 moderate to severe hot flashes over the last week using a special diary.

There are also some reasons why you might not be able to join. For example, if your breast cancer has spread to other parts of your body (metastatic), or if you've recently had surgery or other treatments for breast cancer within the last three months (other than your ongoing hormone therapy). Certain heart conditions could also prevent you from joining. The study team will discuss all of these points with you in detail.

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 between 18 and 70 years old?
Do you get hot flashes because of your anti-cancer hormone therapy?
Do you have a history of, or are you at high risk for, hormone-receptor positive breast cancer?
Have you had at least 35 moderate to severe hot flashes in the last week?
Are you currently undergoing hormone therapy that you will continue during the study?
Do you meet the contraceptive requirements if you are able to have children?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be in the study for about 62 weeks in total, with the main treatment phase lasting 52 weeks. You'll take either elinzanetant or a dummy pill (placebo) as a capsule, once a day. If you start on the placebo, you will switch to elinzanetant after 12 weeks. You'll continue taking your current anti-cancer therapy as usual.

Throughout the study, you'll have up to 12 in-person visits to the study site and 6 phone calls. During these visits, the doctors and nurses will check your overall health and vital signs, like your blood pressure. They will also take blood and urine samples, check your heart with an ECG, and examine your pelvic organs and breasts using scans (like ultrasound and mammograms). You might also have a smear test or a small biopsy of your womb lining if needed. You will be asked to keep a daily diary of your hot flashes and answer questions about your quality of life.

After you finish the 52 weeks of treatment, you'll have a final check-up about 4 weeks later. There's also an option to continue taking elinzanetant for an additional period of up to 3.5 years if you complete the main study.

Potential risks and benefits

While joining a study, you might experience some side effects from the medication, even if it's the placebo. The study team will closely monitor your health and any new symptoms you develop, known as adverse events. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care. The potential benefit of taking part is that elinzanetant might help reduce your hot flashes, which could significantly improve your daily comfort and quality of life while undergoing breast cancer treatment. However, there's no guarantee you will personally benefit from the study, as it's designed to learn more about the drug's effects.

Locations (102)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie
Unverified
Vienna, Austria
MedUni Innsbruck | Brust Gesundheit Zentrum
Verified postcode
Vienna, Austria
Medical University of Graz | Division of Gynecology and Obstetrics
Verified postcode
Salzburg, Austria
ZAS Augustinus - Gynaecology department
Verified postcode
Wilrijk, Belgium
Hôpital Erasme/Erasmus Ziekenhuis
Verified postcode
Brussels, Belgium
CHU Saint-Pierre/UMC Sint-Pieter
Unverified
Bruxelles - Brussel, Belgium
CU Saint-Luc/UZ St-Luc
Unverified
Bruxelles - Brussel, Belgium
Ziekenhuis Oost-Limburg - Gynecology Department
Verified postcode
Genk, Belgium
Ghent University Hospital | Women's Clinic Department
Verified postcode
Ghent, Belgium
UZ Leuven Gasthuisberg
Verified postcode
Leuven, Belgium
Femicare vzw | Tienen, BE
Verified postcode
Tienen, Belgium
The Ottawa Hospital - Riverside Campus
Verified postcode
Ottawa, Canada

Common questions

What are 'hormone-receptor positive breast cancer' and 'vasomotor symptoms'?

Hormone-receptor positive breast cancer is a type where cancer cells grow due to hormones. Vasomotor symptoms are another name for hot flashes and night sweats.

What is a placebo?

A placebo is a 'dummy' pill that looks just like the study drug but doesn't contain any active medicine. It helps us understand if the drug is really working.

Will I know if I'm getting the active drug or the placebo?

No, you won't know initially. Participants are put into groups by chance. However, if you start with the placebo, you will switch to the active drug after 12 weeks.

How long will I be in the study?

You'll be in the study for about 62 weeks, with treatment lasting 52 weeks. There's also a chance to continue treatment for longer if you wish.

What happens if I want to leave the study early?

You can leave the study at any time, for any reason, without it affecting your usual medical care.