New trial opens to treat hot flashes in women with HR-positive breast cancer

***Update 10/10/2024: This study is now closed and is not accepting new participants. ***

An exciting new trial is underway at St Vincent's University Hospital and Mater Misericordiae University Hospital to find a more effective way to treat hot flashes in women with hormone-receptor positive (HR-positive) breast cancer. Hot flashes, also known as vasomotor symptoms (VMS), are a common problem for women undergoing anti-cancer therapy. These flashes, caused by hormonal changes, can significantly impact a woman's quality of life and sometimes even lead to discontinuation of the therapy.

The clinical trial focuses on a new treatment called elinzanetant, which aims to relieve hot flashes. This innovative medication works by blocking a substance called neurokinin, which is believed to trigger these flashes in the body.

The main goal of the study is to compare the effectiveness of elinzanetant to a placebo in reducing hot flashes caused by anti-cancer therapy in women with HR-positive breast cancer or those at high risk of developing it. A placebo is a harmless "dummy" treatment that looks like the real medication but doesn't have any active ingredients.

During the trial, participants will keep an electronic diary to track information about their hot flashes before starting the treatment and at specific intervals throughout the study. Researchers will analyze the average changes in the number and severity of hot flashes after 4 and 12 weeks of treatment.

Safety is a top priority, so the trial will closely monitor any potential side effects of elinzanetant compared to the placebo.

Participants will be randomly assigned to one of two groups: Group A or Group B. Group A will receive elinzanetant, while Group B will start with the placebo and then switch to elinzanetant.

It's important to note that all participants will continue their current anti-cancer therapy throughout the study.

Depending on their assigned group, participants will take either elinzanetant or placebo capsules once a day. After 12 weeks, those initially receiving the placebo will switch to elinzanetant for the remaining 40 weeks.

This clinical trial brings hope for women with HR-positive breast cancer who suffer from hot flashes. By exploring the potential of elinzanetant, researchers aim to improve the quality of life for these patients and find better ways to manage this common side effect of anti-cancer therapy. 

The PI, Prof Donal Brennan, is accepting referrals nationally. 

Clinical Trial Registration: (opens in a new window)NCT05587296