RecruitingPHASE1, PHASE2INTERVENTIONAL

Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer

This research is investigating two medications, Elacestrant and Abemaciclib, combined together. The study is for people who have breast cancer that has spread to their brain. Specifically, it's for a type of breast cancer known as ER-positive and HER-2 negative. These new drug combinations are being tested to explore their effectiveness and safety when used together. The first part of the study (Phase 1b) aimed to find the best dose of these medicines when given together. Now, in the ongoing second part (Phase 2), researchers are using that dose to further evaluate how well this combination works for patients with active brain tumours caused by this specific type of breast cancer.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Stemline Therapeutics, Inc.

Enrolment target

Start

31 Aug 2022

Estimated completion

01 Dec 2026

Breast Neoplasms Brain Neoplasms Neoplasms by Site Neoplasms Breast Diseases Central Nervous System Neoplasms Brain Diseases Central Nervous System Diseases

What is this study about?

This research study is looking into a new way to treat breast cancer that has spread to the brain. When cancer spreads from its original site, it's called 'metastatic cancer'. In this case, the breast cancer has formed new growths in the brain. The study is specifically focused on a common type of breast cancer that is 'ER-positive' (meaning it grows in response to hormones like oestrogen) and 'HER-2 negative' (another protein often found on cancer cells, but in this case, it's not present).

The study is testing a combination of two medications: Elacestrant and Abemaciclib. Elacestrant is designed to target the oestrogen receptor, which helps block the growth of ER-positive breast cancer. Abemaciclib works differently; it's a type of drug called a CDK4/6 inhibitor, which helps to slow down the growth of cancer cells. By combining these two drugs, researchers hope they might be more effective together than either drug alone in treating breast cancer that has spread to the brain.

The study has two main parts. The first part, called Phase 1b, was about finding the safest and most effective dose of these two drugs when given together. Now that the best dose has been identified, the study is in Phase 2. This current phase is looking more closely at how well this drug combination works for people whose ER-positive, HER-2 negative breast cancer has spread to their brain and is actively growing.

Key takeaways

The study combines two drugs, Elacestrant and Abemaciclib, for metastatic breast cancer.
It targets breast cancer that's spread to the brain, specifically ER-positive, HER-2 negative type.
The initial phase found the right drug dose; now we're seeing how well it works.
Participation involves taking new medications and regular check-ups.
Both men and women aged 18+ can join if they meet specific breast cancer criteria.

Who may be eligible?

To join this study, participants must be at least 18 years old. Both women and men can take part. For women, this includes those who have gone through menopause as well as those who are still having periods. If you are a woman who still has periods or a man, you will need to be receiving another treatment called an LHRH agonist, which helps to reduce certain hormones, before starting the study drugs and continue it throughout the study.

Your breast cancer must be specifically of the type called 'ER-positive' and 'HER-2 negative'. This means your cancer cells react to oestrogen but don't have too much of another protein called HER-2. This will have been checked by your doctors using a sample from your tumour. For the later stage of the study, you must also have at least one active brain tumour that can be measured.

Quick self-check

Are you 18 years old or older?
Has your doctor confirmed your breast cancer is ER-positive and HER-2 negative?
Do you have breast cancer that has spread to your brain and is actively growing?
If you are a woman who still has periods, or a man, are you already taking or willing to take a specific hormone-reducing medication (LHRH agonist)?
Are you able to sign a consent form and understand what taking part means?

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

What does participation involve?

If you decide to take part in this study, you will have regular visits to the hospital or clinic. During these visits, the doctors will check your general health, conduct physical examinations, and take blood samples. You will be given the study medications, Elacestrant and Abemaciclib, which you will take as prescribed. The medical team will closely monitor you for any side effects and see how your body is responding to the treatment.

They will also perform scans like MRI to check the size and activity of the brain tumours. The exact number of visits and the duration of your participation will depend on how you respond to the treatment and the study's protocol, but it will involve ongoing assessments as long as you are on the study drugs and sometimes after you stop. The specific length of time you'll be involved can be discussed in detail with the study team.

Potential risks and benefits

Like all medical treatments, there may be some benefits and risks to taking part in this study. A potential benefit could be that the new drug combination helps to control your breast cancer in the brain more effectively than standard treatments. However, there's no guarantee it will work for everyone, and it might not help you at all. As with any medication, Elacestrant and Abemaciclib can have side effects, which the study team will discuss with you in detail. These could include things like fatigue, nausea, or other reactions. Your safety will be closely monitored throughout the study. Remember, if you join, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (86)

Providence Medical Foundation
Fullerton, United States· Recruiting
California Research Institute
Los Angeles, United States· Recruiting
Carle Cancer Center
Urbana, United States· Recruiting
Dana-Farber Cancer Institute
Boston, United States· Recruiting
Henry Ford Hospital
Detroit, United States· Recruiting
Miami Valley Hospital South
Centerville, United States· Recruiting
Oregon Health & Science University
Portland, United States· Completed
SCRI Oncology Partners
Nashville, United States· Recruiting
University of Texas MD Anderson Cancer Center
Houston, United States· Recruiting
UT Health San Antonio University of Texas
San Antonio, United States· Completed
Virginia Cancer Institute
Norfolk, United States· Recruiting
Antwerp University Hospital
Edegem, Belgium· Recruiting

+74 more sites — see the official record for the full list.

Common questions

What does 'ER-positive, HER-2 negative' mean?

This describes a specific type of breast cancer. 'ER-positive' means the cancer cells grow in response to hormones like oestrogen. 'HER-2 negative' means the cancer cells don't have a high level of another protein called HER-2.

What are brain metastases?

Brain metastases are tumours that form in the brain when cancer cells from another part of the body, like the breast, spread there. They are not the same as a primary brain tumour.

What are Elacestrant and Abemaciclib?

They are both medications. Elacestrant works by blocking the effect of oestrogen on cancer cells. Abemaciclib helps slow down how fast cancer cells grow and divide.

Is this a new treatment?

Yes, this study is looking at these two drugs combined. While the drugs might be used individually for breast cancer, their combination for breast cancer that has spread to the brain is being studied to see how effective and safe it is.

How long does the study last?

The total length of time you would be involved can vary. Your doctor or the study team can give you more specific details based on the current stage of the study and your individual treatment plan.

How to find out more

Stemline Trials

clinicaltrials@menarinistemline.com 1-877-332-7961 Official trial record

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