EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence

New drug imlunestrant tested against standard hormone therapy for early breast cancer

NCT: NCT05514054 · Status: ACTIVE NOT RECRUITING · Phase: Phase 3 · Sponsor: Eli Lilly and Company · Started: 2022-10-04 · Est. Completion: 2032-03

Plain English Summary

A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer is a Phase 3 clinical trial sponsored by Eli Lilly and Company studying Breast Neoplasms. This trial tests if a new drug, imlunestrant, is better than standard hormone therapy at preventing early breast cancer from returning. It is for patients with early-stage breast cancer that is ER+ and HER2-, who have already completed 2-5 years of hormone therapy and have a higher risk of recurrence. Participation involves taking either imlunestrant or standard hormone therapy for up to 10 years, with regular check-ups and tests. Standard hormone therapies like tamoxifen, anastrozole, letrozole, or exemestane are the current alternatives. The trial aims to enroll 8000 participants.

Official Summary

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

Here is what you need to know about eligibility for this trial. You can join if you have ER+, HER2- early breast cancer that has been treated and has not spread to distant parts of the body. You must have taken hormone therapy for 2 to 5 years and have features suggesting your cancer might come back. You cannot join if your cancer has spread, you had a long break in previous hormone therapy, or you have a history of other cancers (with some exceptions). This trial is studying Breast Neoplasms, so participants generally need a confirmed diagnosis.

What They're Measuring

The main goal is to see if imlunestrant can prevent the cancer from returning or causing death for a longer period compared to standard hormone therapy. The specific primary outcome measures are: Invasive Disease-Free Survival (IDFS) (Randomization to recurrence or death from any cause (up to 10 years)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a critical need for more effective treatments to prevent the recurrence of early breast cancer in patients at high risk, potentially offering a new option beyond current standard As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Breast Neoplasms, where improved treatment options are needed.

Investor Insight

This Phase 3 trial for a novel endocrine therapy in a large patient population with high unmet need signals significant market potential, with Eli Lilly aiming to capture a share of the multi-billion Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 8000 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about the potential benefits and risks of imlunestrant versus your current therapy. Understand the time commitment, which could be up to 10 years, and the frequency of study visits and tests. Be prepared for regular monitoring of your health and cancer status throughout the study. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

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 a history of previous breast cancer are excluded, with the exception of ipsilateral DCIS treated by locoregional therapy alone ≥5 years ago.
* Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of study intervention.
* Participant has previously received ET of any duration for breast cancer prevention (tamoxifen or AIs) or raloxifene.
* Participants with a history of any other cancer.
* Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT05514054?

NCT05514054 is a Phase 3 INTERVENTIONAL study titled "A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer." It is currently active, not recruiting and is sponsored by Eli Lilly and Company. The trial targets enrollment of 8000 participants.

What conditions does NCT05514054 study?

This trial investigates treatments for Breast Neoplasms. The primary condition under study is Breast Neoplasms.

What treatments are being tested in NCT05514054?

The interventions being studied include: Imlunestrant (DRUG), Tamoxifen (DRUG), Anastrozole (DRUG), Letrozole (DRUG), Exemestane (DRUG). Administered orally.

What does Phase 3 mean for NCT05514054?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT05514054?

This trial is currently "Active, Not Recruiting." It started on 2022-10-04. The estimated completion date is 2032-03.

Who is sponsoring NCT05514054?

NCT05514054 is sponsored by Eli Lilly and Company. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT05514054?

The trial aims to enroll 8000 participants. The trial status is active, not recruiting.

How is NCT05514054 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT05514054?

The primary outcome measures are: Invasive Disease-Free Survival (IDFS) (Randomization to recurrence or death from any cause (up to 10 years)). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT05514054 being conducted?

This trial is being conducted at 20 sites, including Daphne, Alabama; Huntsville, Alabama; Mobile, Alabama; Gilbert, Arizona and 16 more sites (United States).

Where can I find official information about NCT05514054?

The official record for NCT05514054 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05514054. This government database provides the most up-to-date and detailed information about the trial.

What is NCT05514054 testing in simple terms?

This trial tests if a new drug, imlunestrant, is better than standard hormone therapy at preventing early breast cancer from returning. It is for patients with early-stage breast cancer that is ER+ and HER2-, who have already completed 2-5 years of hormone therapy and have a higher risk of recurrence.

Why is this trial significant?

This trial addresses a critical need for more effective treatments to prevent the recurrence of early breast cancer in patients at high risk, potentially offering a new option beyond current standard As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT05514054?

Potential side effects of imlunestrant are being studied, but may include those similar to other hormone therapies, such as hot flashes, joint pain, and fatigue. As this is an open-label study, both you and your doctor will know which treatment you are receiving, which could influence your perception of side effects. There is a risk that the cancer could still return despite treatment, or that new health problems could arise. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT05514054?

Ask your doctor about the potential benefits and risks of imlunestrant versus your current therapy. Understand the time commitment, which could be up to 10 years, and the frequency of study visits and tests. Be prepared for regular monitoring of your health and cancer status throughout the study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT05514054 signal from an investment perspective?

This Phase 3 trial for a novel endocrine therapy in a large patient population with high unmet need signals significant market potential, with Eli Lilly aiming to capture a share of the multi-billion This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participation involves taking either imlunestrant or standard hormone therapy for up to 10 years, with regular check-ups and tests. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.