RecruitingPHASE3INTERVENTIONAL

A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence

This research study is looking at a new medicine called Elacestrant for people with early breast cancer. The breast cancer must be ER-positive (meaning it grows with hormones) and HER2-negative, and doctors think it has a high risk of returning. The study wants to compare Elacestrant with the usual hormone treatments like Anastrozole or Tamoxifen. We want to find out if Elacestrant is more effective at preventing the cancer from coming back. This is a Phase 3 study, which means it’s a later stage of research before a drug can be widely used. Both men and women aged 18 and over, who have already had some hormone therapy for their breast cancer, might be able to take part.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Stemline Therapeutics, Inc.

Enrolment target

4,220

Start

27 Sep 2024

Estimated completion

01 Oct 2032

Breast Cancer

What is this study about?

This study is about finding better ways to treat early breast cancer. Your doctors might classify your cancer as ER-positive (meaning it's sensitive to hormones like oestrogen) and HER2-negative (meaning it doesn't have a lot of a specific protein called HER2). This type of breast cancer is often treated with hormone therapy, which aims to block the effects of oestrogen and stop the cancer from growing.

In this study, researchers are looking at a new drug called Elacestrant. They want to see if it works better than the standard hormone treatments that are currently used. The main goal is to find out if Elacestrant can do a better job at preventing the breast cancer from returning in people whose cancer has a high chance of coming back. Knowing if a new treatment is more effective could help improve care for many people in the future.

This is an important step in developing new medicines. If Elacestrant proves to be better, it could offer another option for managing early breast cancer and give people hope for a longer, healthier life. Your participation in a study like this could make a real difference to future patients.

Key takeaways

This study compares a new drug (Elacestrant) with standard hormone treatments.
It's for early breast cancer that is ER-positive and HER2-negative.
The aim is to see if the new drug can better prevent cancer from returning.
Participants must have a high risk of their breast cancer coming back.
Both men and women, aged 18+, who have had some prior hormone therapy can take part.
It's a Phase 3 study, meaning it's a later stage of research.

Who may be eligible?

To join this study, you would need to have specific types of breast cancer. This includes breast cancer that has already been surgically removed and is ER-positive (meaning it is affected by hormones) and HER2-negative. Your doctors must also believe your cancer has a high chance of coming back after treatment, and it shouldn't have spread to other parts of your body. You also need to have been on hormone therapy (like Anastrozole or Tamoxifen) for at least two years but no more than five years already.

There are also some reasons why you might not be able to join. For example, if you have a history of inflammatory breast cancer or if you've had invasive breast cancer before on either side. You also can't have had certain other cancers in the last three years, apart from some easily treated skin cancers or very early cervical cancer. Also, if you took a break of more than six months from your usual hormone therapy, you might not be able to take part.

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.

Have you had breast cancer surgery with no signs of it returning or spreading?
Is your breast cancer ER-positive and HER2-negative?
Have your doctors said your breast cancer has a high chance of coming back?
Have you been on hormone therapy for your breast cancer for 2 to 5 years?
Are you 18 years old or older?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given either Elacestrant or one of the standard hormone treatments. You wouldn't get to choose which one you receive, as this is decided randomly, like flipping a coin. You would have regular visits to the clinic for check-ups, blood tests, and to make sure you're feeling okay. The study team will monitor your health closely and ask about any side effects you might experience.

The specific details of how many visits, what tests are involved, and how long you'll be in the study will be fully explained by the study team. Usually, these studies involve taking medication for a period, typically several years, and having follow-up appointments even after you stop taking the study drug. All of this will be thoroughly discussed with you before you make any decisions.

Potential risks and benefits

Taking part in a clinical study might offer some potential benefits, such as receiving a new treatment that could be more effective than current ones, or getting extra medical care and monitoring. However, there are also potential risks. The new drug might have side effects that aren't fully known, or it might not work as well as the standard treatment. The standard treatments also have their own known side effects. It's really important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (541)

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

Southern Cancer Center, PC
Verified postcode
Daphne, United States· Recruiting
Ironwood Cancer and Research Centers
Verified postcode
Chandler, United States· Recruiting
Banner MD Anderson Cancer Center
Verified postcode
Gilbert, United States· Recruiting
Mayo Clinic
Verified postcode
Scottsdale, United States· Recruiting
Arizona Clinical Research Center, Inc.
Verified postcode
Tucson, United States· Recruiting
University of Arizona Cancer Center
Verified postcode
Tucson, United States· Recruiting
Highlands Oncology Group, PA
Verified postcode
Springdale, United States· Recruiting
Comprehensive Blood & Cancer Center
Verified postcode
Bakersfield, United States· Recruiting
UCSF Cancer Center Berkeley
Verified postcode
Berkeley, United States· Recruiting
Cedars-Sinai Cancer Beverly Hills
Verified postcode
Beverly Hills, United States· Recruiting
City of Hope National Medical Center
Verified postcode
Duarte, United States· Recruiting
UCSF Wash Cancer CNTR
Verified postcode
Fremont, United States· Recruiting

Common questions

What does ER-positive and HER2-negative mean?

ER-positive means the cancer cells grow with the help of hormones like oestrogen. HER2-negative means the cancer cells don't have a lot of a specific protein called HER2.

What is Elacestrant?

Elacestrant is a new type of drug being tested to treat breast cancer that feeds on hormones (ER-positive).

What are standard hormone treatments?

These are common medicines like Anastrozole, Letrozole, Exemestane, or Tamoxifen that are used to block or reduce hormone effects on breast cancer.

Why is this a 'high risk of recurrence' study?

This means the study is focusing on people whose doctors believe their breast cancer has a greater chance of coming back after initial treatment.

Who can join this study?

Both men and women aged 18 or older with specific types of early breast cancer who have already been on some hormone therapy.

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.