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

Comparing Imlunestrant to usual hormone therapy for early breast cancer.

Recruiting
18 years and older
All
Phase 3

This study compares **imlunestrant**, a new drug, to standard hormone therapy for people with early breast cancer that is **estrogen receptor positive (ER+)** and **human epidermal receptor 2 negative (HER2-)**. ER+ means the cancer cells grow in response to estrogen, a hormone, while HER2- indicates they do not have too much of a protein called HER2. To join, participants must have taken hormone therapy for 2-5 years and have a higher risk of cancer returning. The study might last up to 10 years.

Key Points:

  • Study duration can be up to 10 years.
  • Participants might have taken hormone therapy for 2-5 years before joining.
  • Eligibility includes having a higher risk of cancer returning.

If you have had metastatic disease, gaps in hormone therapy, or other types of cancer, you may not be eligible. Pregnant or breastfeeding people are also excluded. It's important to discuss with your doctor if this study is a good fit for you.

Study details
    Breast Neoplasms

NCT05514054

Eli Lilly and Company

28 June 2025

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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