What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as Selective Estrogen Receptor Degraders (like Imlunestrant) and CDK4/6 inhibitors (like Abemaciclib), have specific side effects. Imlunestrant, compared to standard hormone therapies, may share side effects such as gastrointestinal issues and increased risk of venous thromboembolism (VTE) with tamoxifen. Aromatase inhibitors, another common hormone therapy, can lead to bone density loss and cardiovascular risks. Abemaciclib, a CDK4/6 inhibitor, is associated with side effects like diarrhea and neutropenia, which are generally manageable with supportive care.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that are similar to Imlunestrant and Abemaciclib. For instance, Fulvestrant is a Selective Estrogen Receptor Degrader (SERD) that has been approved for hormone receptor-positive metastatic breast cancer. Additionally, Abemaciclib, a CDK4/6 inhibitor, has been approved for use in combination with endocrine therapy for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer. Other CDK4/6 inhibitors like Palbociclib and Ribociclib have also received FDA approval for similar indications.

What other types of research exist?

Promising novel alternatives to Imlunestrant and Abemaciclib for breast cancer patients include: 1) PI3K inhibitors such as Alpelisib, which targets the PI3K pathway and has shown efficacy in combination with endocrine therapy. 2) mTOR inhibitors like Everolimus, which can be combined with aromatase inhibitors for enhanced efficacy. 3) Immune checkpoint inhibitors such as Pembrolizumab, which have shown promise in combination with other therapies for certain subtypes of breast cancer. These alternatives offer different mechanisms of action and have demonstrated potential in clinical trials.

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Aromatase Inhibitor

Imlunestrant + Abemaciclib for Breast Cancer (EMBER-3 Trial)

Phase 3

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer

Have disease that has demonstrated progression on or after an aromatase inhibitor alone or in combination with a cyclin-dependent kinase (CDK)4/6 inhibitor

Must not have

Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, or any investigational-ER-directed therapy (including SERDs and non-SERDs), any PI3K-, mTOR- or AKT- inhibitor

Have visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization until death from any cause (estimated as up to 5 years)

Awards & highlights

Summary

This trial is testing a new drug called imlunestrant, alone and in combination with another drug, abemaciclib, for patients with advanced breast cancer that is ER+ and HER2-. Imlunestrant works by blocking estrogen receptors on cancer cells, while abemaciclib stops the cells from multiplying. The goal is to see if these treatments work better than standard hormone therapy.

Who is the study for?

This trial is for postmenopausal women with advanced breast cancer that's ER+ and HER2-. They should have seen their cancer progress after aromatase inhibitor treatment, possibly combined with a CDK4/6 inhibitor. Participants must be able to take pills, have measurable disease or bone-only disease, and be in good physical condition (ECOG 0-1). They can't join if they've had certain prior treatments like chemotherapy or specific inhibitors, have severe brain metastasis, visceral crisis, lung complications from cancer spread, or serious medical conditions.

What is being tested?

The study tests the effectiveness of Imlunestrant against standard hormone therapy and combines Imlunestrant with Abemaciclib versus Imlunestrant alone in treating ER+, HER2- advanced breast cancer. The goal is to see which treatment works better for patients whose cancer has spread. Participation could last up to five years.

What are the potential side effects?

Potential side effects may include typical reactions associated with hormone therapies such as hot flashes, fatigue, joint pain; and those related to Abemaciclib like diarrhea, low white blood cell counts increasing infection risk. Each patient's experience may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is ER+ and HER2-, and has spread beyond the breast.

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My cancer progressed after treatment with an aromatase inhibitor and possibly a CDK4/6 inhibitor.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer progressed after treatment with an aromatase inhibitor and possibly a CDK4/6 inhibitor.

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I can swallow pills.

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I am postmenopausal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously been treated with specific cancer therapies, excluding early-stage chemotherapy.

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My cancer has spread to my organs, lungs, or brain/spinal cord linings.

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I have brain metastasis that is causing symptoms or has not been treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization until death from any cause (estimated as up to 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization until death from any cause (estimated as up to 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization until death from any cause (estimated as up to 5 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PFS in the Estrogen Receptor 1 (ESR1)-mutation Detected Population

Progression Free Survival (PFS) in the Intent-to-Treat (IIT) Population

Secondary study objectives

Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve a Best Overall Response of CR, PR or Stable Disease for Greater than or Equal to (≥) 24 Weeks

Duration of Response (DoR)

OS in the ESR1-mutation Detected Population

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Imlunestrant plus AbemaciclibExperimental Treatment2 Interventions

Imlunestrant plus abemaciclib administered orally.

Group II: ImlunestrantExperimental Treatment1 Intervention

Imlunestrant administered orally.

Group III: Investigator's Choice of Endocrine TherapyActive Control2 Interventions

Investigator's choice of exemestane administered orally or fulvestrant administered intramuscularly (IM). See local approved label for additional instructions.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Imlunestrant

2022

Completed Phase 1

~170

Abemaciclib

2019

Completed Phase 2

~1800

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Selective Estrogen Receptor Degraders (SERDs) like Imlunestrant work by binding to estrogen receptors on cancer cells, causing receptor degradation and inhibiting estrogen-driven cancer cell growth. CDK4/6 inhibitors like Abemaciclib block cyclin-dependent kinases 4 and 6, essential for cell cycle progression, thereby preventing cancer cell division. These targeted therapies are crucial for breast cancer patients as they disrupt specific pathways critical for cancer cell survival, offering more effective and personalized treatment options.