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NCT05514054RECRUITINGIRB Ready

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

(EMBER-4)

Sponsored by Eli Lilly and Company

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
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1 of 8000 participants interested
0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.

Who Can Participate

Inclusion Criteria

Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis.
Participants must have received at least 24 months but not more than 60 months of any adjuvant ET, from time of adjuvant ET initiation.
Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy with a CDK4/6- or PARP- inhibitor.
Must have an increased risk of disease recurrence based on clinical-pathological risk features.
Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale.
Have adequate organ function.

Exclusion Criteria

Have any evidence of metastatic disease (including contralateral ALN) or inflammatory breast cancer at primary breast cancer diagnosis.
Participants with more than a 6-month consecutive gap in therapy during the course of prior adjuvant ET.
Participants who have completed or discontinued prior adjuvant ET \>6 months prior to screening.
Participants with

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

8000 participants

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Gender

ALL

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Sponsor

Eli Lilly and Company

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Daphne

Alabama

Location available
View Daphne location page
RECRUITING

Huntsville

Alabama

Location available
View Huntsville location page
RECRUITING

Mobile

Alabama

Location available
View Mobile location page
RECRUITING

Gilbert

Arizona

Location available
View Gilbert location page
RECRUITING

Glendale

Arizona

Location available
View Glendale location page
RECRUITING

Phoenix

Arizona

Location available
View Phoenix location page
RECRUITING

Phoenix

Arizona

Location available
View Phoenix location page
RECRUITING

Tucson

Arizona

Location available
View Tucson location page
RECRUITING

Tucson

Arizona

Location available
View Tucson location page

๐Ÿ“ And 128 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Breast Cancer Treatment in Daphne?

Join others in Alabama exploring innovative treatment options through clinical research

Breast Cancer Treatment Options in Daphne, Alabama

If you're searching for Breast Cancer treatment in Daphne, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Daphne, Huntsville, Mobile and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Breast Cancer. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 8000 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Breast Cancer?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Breast Cancer

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Breast Cancer Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05514054. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.