Active not recruitingPHASE3INTERVENTIONAL

A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer

This research study is investigating a new medication called imlunestrant for people with early-stage breast cancer. This type of cancer is sensitive to hormones (oestrogen receptor positive, ER+) and doesn't have too much of a protein called HER2. Participants in the study would have already received standard hormone therapy for two to five years and are at a higher-than-average risk for their cancer to come back. The study aims to compare how well imlunestrant works against commonly used hormone treatments like tamoxifen, anastrozole, letrozole, or exemestane in preventing the breast cancer from returning. Taking part could last up to 10 years.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

8,000

Start

04 Oct 2022

Estimated completion

01 Mar 2032

Breast Neoplasms

What is this study about?

This study, called a Phase 3 clinical trial, is looking at a new treatment named imlunestrant for people who have had early-stage breast cancer. This particular type of breast cancer is known as oestrogen receptor positive (ER+) and HER2-negative (HER2-). This means the cancer cells grow in response to the hormone oestrogen, but don't have high levels of another protein called HER2.

The main goal is to find out if imlunestrant is more effective than standard hormone treatments, such as tamoxifen, anastrozole, letrozole, or exemestane, at stopping the cancer from returning. Participants in this study will have already completed between two and five years of one of these standard hormone therapies and are considered to have a higher chance of their cancer coming back. The researchers want to see if adding imlunestrant can further reduce this risk.

Understanding how well new treatments work and comparing them to existing options is crucial for improving care for breast cancer patients. This research could potentially offer a new treatment strategy for those at a higher risk of recurrence, aiming to keep them cancer-free for longer.

Key takeaways

Tests a new drug (imlunestrant) for early breast cancer.
Compares it to standard hormone therapies.
For ER+, HER2- breast cancer at higher risk of returning.
Participants have already had 2-5 years of hormone therapy.
Study could last up to 10 years, including follow-up.

Who may be eligible?

To join this study, you would typically need to be an adult with early-stage breast cancer that has been removed by surgery. Your cancer must be oestrogen receptor positive (ER+) and HER2-negative (HER2-), and it shouldn't have spread to other parts of your body.

Before considering this study, you must have already been on standard hormone therapy for your breast cancer for at least two years but no more than five years. You are also considered for the study if your doctors believe your cancer has a higher risk of returning.

There are some reasons why you might not be able to join. For example, if your cancer has spread (become metastatic) or if you've already had a significant break in your previous hormone therapy. You also cannot be pregnant or breastfeeding, or planning to become a parent during the study, nor can you have a history of other specific types of cancer or serious medical conditions that would make taking part unsafe.

Quick self-check

Have you had early-stage breast cancer that was removed by surgery?
Is your breast cancer oestrogen receptor positive (ER+) and HER2-negative (HER2-)?
Have you completed between 2 to 5 years of hormone therapy for your breast cancer?
Are you at a higher risk of your breast cancer returning, as determined by your doctor?
Are you not pregnant or breastfeeding, and not planning to become pregnant or father a child during the study?
Do you have good general health and acceptable organ function?

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 would receive either the new drug, imlunestrant, or a standard hormone treatment like tamoxifen, anastrozole, letrozole, or exemestane. You wouldn't know which treatment you are getting. Throughout the study, you would have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how well the treatment is working.

The study would involve taking medication, likely a tablet, as prescribed by the study doctors. You would be closely monitored for any side effects. The total commitment for this study could be quite long, possibly up to 10 years, including regular follow-up appointments even after you stop taking the study medication. Doctors will discuss the full schedule of visits and tests with you.

Potential risks and benefits

Participating in this study might offer the potential benefit of a new treatment that could be more effective at preventing your breast cancer from returning compared to standard therapy. However, there's no guarantee the new drug will work for everyone, and it might not be any better than existing treatments. Like all medications, both imlunestrant and the standard hormone therapies carry potential risks of side effects, which can vary from mild to more serious. All risks will be fully explained before you decide to join. It is very important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (672)

USO - Southern Cancer Center
Daphne, United States
Clearview Cancer Institute
Huntsville, United States
Infirmary Cancer Care
Mobile, United States
Banner MD Anderson Cancer Center
Gilbert, United States
USO - Arizona Oncology Associates - HAL
Glendale, United States
St. Joseph's Hospital and Medical Center
Phoenix, United States
Mayo Clinic in Arizona - Phoenix
Phoenix, United States
TMC HealthCare
Tucson, United States
The University of Arizona Cancer Center - North Campus
Tucson, United States
Highlands Oncology Group
Springdale, United States
UCSF - John Muir Health Cancer Center Berkeley
Berkeley, United States
Washington Health
Fremont, United States

+660 more sites — see the official record for the full list.

Common questions

What does 'oestrogen receptor positive (ER+)' breast cancer mean?

It means the breast cancer cells have special proteins (receptors) that attach to the hormone oestrogen, which helps them grow. Treatments for this type of cancer often block oestrogen or stop its production.

What is 'HER2-negative (HER2-)'?

This means your breast cancer cells do not have high levels of a protein called HER2. This is important because it tells doctors which targeted treatments might or might not work for your cancer.

Why is the study looking at people with a 'higher risk' of recurrence?

The study focuses on these individuals because they are most likely to benefit if a new treatment can further reduce the chance of their cancer coming back. It targets a specific group who might need more help beyond current standard treatments.

How long will I have to take the study medication?

The information provided doesn't specify the exact duration of taking the medication, but states that overall study participation, including follow-up, could last up to 10 years.

Will I know if I'm getting the new drug or a standard treatment?

No, in this type of study (called 'blinded'), you and your doctors wouldn't know whether you are receiving the new drug (imlunestrant) or a standard hormone therapy. This is done to ensure the study results are as fair and unbiased as possible.