RecruitingPHASE3INTERVENTIONAL

Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.

This research study is looking into a new treatment for advanced breast cancer that is ER-positive and HER2-negative, and has a specific change in the ESR1 gene. Participants in the study have already received other hormone-based treatments and a CDK4/6 inhibitor, but their cancer has continued to grow. The main goal is to find out if combining two medicines, elacestrant and everolimus, is more effective at stopping or slowing down cancer growth than elacestrant with a dummy pill (placebo). We want to see how long patients live without their cancer getting worse when taking this combination. This study aims to offer a new potential treatment option for patients who have limited choices left.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

MedSIR

Enrolment target

240

Start

05 Dec 2024

Estimated completion

01 Apr 2028

Advanced Breast Cancer ER-positive Breast Cancer HER2-negative Breast Cancer ESR1 Gene Mutation

What is this study about?

This study is looking at a new treatment for a specific type of advanced breast cancer. This cancer is known as 'ER-positive' (meaning its growth is helped by the hormone oestrogen) and 'HER2-negative' (meaning it doesn't have too much of a protein called HER2). Importantly, the cancer in this study also has a specific genetic change called an 'ESR1 mutation'. This mutation can sometimes make cancer cells resist standard hormone treatments.

Patients taking part in this study will have already tried other common treatments, including hormone therapy and a drug called a CDK4/6 inhibitor, but their cancer has unfortunately started to grow again. The study aims to test a new medicine called elacestrant. Elacestrant works by breaking down the oestrogen receptor protein in cancer cells, which helps to stop their growth. This new drug will be given alongside an existing medicine called everolimus, or with a dummy pill (placebo) to see if the combination is more effective. Everolimus is already used for some types of advanced breast cancer.

The main question the researchers want to answer is how long patients can go without their cancer getting worse when they receive elacestrant plus everolimus, compared to elacestrant plus a placebo. Finding good treatments for breast cancer that has continued to grow despite previous therapies is very important, and this study hopes to identify a new, effective option for patients with this particular type of cancer.

Key takeaways

This study tests a new drug for advanced ER+/HER2- breast cancer with an ESR1 mutation.
It's for people whose cancer has grown despite previous hormone and CDK4/6 inhibitor treatments.
The study compares elacestrant plus everolimus versus elacestrant plus a dummy pill.
The main goal is to see how long patients live without their cancer getting worse.
Participants will take daily pills and have regular check-ups and follow-up.

Who may be eligible?

To join this study, you must be 18 years or older. You should have been diagnosed with advanced breast cancer that is ER-positive and HER2-negative, and has a specific change in the ESR1 gene. Your cancer must have continued to grow after you've had previous hormone treatments and a type of drug called a CDK4/6 inhibitor.

Women who are still having periods (pre- or perimenopausal) or men will need to be on specific hormone-blocking injections (LHRH analogues) before and during the study. If you've gone through menopause, there are specific definitions for this based on your age, if your periods have stopped for a long time, or if you've had surgery to remove your ovaries.

The research staff will review your medical history and test results very carefully to make sure the study treatment is as safe as possible for you. They'll check for any other health issues that might make taking part risky.

Quick self-check

Are you 18 years old or older?
Do you have advanced breast cancer that is ER-positive and HER2-negative?
Has your cancer been found to have an ESR1 gene change?
Has your cancer grown after trying previous hormone therapy and a CDK4/6 inhibitor?
If you are a woman who still has periods or a man, are you receiving specific hormone-blocking injections?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you'll first sign a consent form, making sure you understand everything involved. Then, you'll be randomly assigned to one of two groups, like flipping a coin. One group will take elacestrant plus everolimus every day, and the other group will take elacestrant plus a dummy pill (placebo) every day. You won't know which group you are in.

You will take the study medicine daily in 28-day cycles. You will continue treatment for as long as it is helping you, or until your cancer shows signs of growing, you experience side effects that are too difficult to manage, or you decide to stop for any other reason. Throughout this time, you will have regular check-ups, scans, and tests to monitor your health and how the treatment is working.

After you stop taking the study treatment, you will enter a follow-up period. During this time, the research team will check in with you every three months to see how you are doing, track your survival, and gather information about any other cancer treatments you might receive. This follow-up will continue for about 12 months after the last patient starts the study, or until the study officially ends.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as receiving a new treatment that might be more effective than other options for your specific cancer. You'll also be closely monitored by a dedicated medical team. However, there are also potential risks; the study drugs may cause side effects, some of which could be serious. The new treatments might not work for everyone, or they might not work as well as expected. Sometimes, new treatments are no better than existing ones, or even worse. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (99)

Medizinische Universität Innsbruck
Innsbruck, Austria· Recruiting
Ordensklinikum Linz Barmherzige Schwestern
Linz, Austria· Recruiting
Ordination Priv.-Doz. Dr. Michael Hubalek
Schwaz, Austria· Recruiting
Medical University of Vienna
Vienna, Austria· Not yet recruiting
Tacchini Instituto de Pesquisa
Bento Gonçalves, Brazil· Not yet recruiting
Hospital Cachoeiro de Itapemirim
Cachoeiro de Itapemirim, Brazil· Not yet recruiting
Catarina Pesquisa Clínica - Neoplasias Litoral
Itajaí, Brazil· Not yet recruiting
UPCO - Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil· Not yet recruiting
NOB Ondina
Salvador, Brazil· Not yet recruiting
Masaryk Memorial Cancer Institute
Brno, Czechia· Recruiting
Multiscan Nemocnice Horovice
Hořovice, Czechia· Recruiting
University Hospital Olomouc
Olomouc, Czechia· Not yet recruiting

+87 more sites — see the official record for the full list.

Common questions

What is 'advanced breast cancer'?

Advanced breast cancer means the cancer has spread beyond the breast and nearby lymph nodes to other parts of the body.

What does ER-positive and HER2-negative mean?

ER-positive means the cancer cells use oestrogen to grow. HER2-negative means the cancer cells don't have too much of a protein called HER2, which guides certain treatments.

What is an ESR1 mutation?

An ESR1 mutation is a genetic change in the cancer cells that can sometimes make them resistant to standard hormone treatments.

What is a 'placebo'?

A placebo is a dummy pill that looks like the actual medicine but contains no active drug. It helps researchers fairly compare how well the new treatment works.

Will I know which treatment I am getting?

No, this is a 'blinded' study, meaning neither you nor your doctors will know if you are receiving everolimus or the placebo, to keep the results unbiased.

How to find out more

Medsir

contact.trials@medsir.org +34932214135 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.