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Aromatase Inhibitor
Imlunestrant + Abemaciclib for Breast Cancer (EMBER-3 Trial)
Phase 3
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization until death from any cause (estimated as up to 5 years)
Awards & highlights
EMBER-3 Trial Summary
This trial is testing a new drug to see if it's more effective than standard hormone therapy for treating breast cancer.
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.Check my eligibility
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.See study design
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.
EMBER-3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is ER+ and HER2-, and has spread beyond the breast.
Select...
My cancer progressed after treatment with an aromatase inhibitor and possibly a CDK4/6 inhibitor.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer progressed after treatment with an aromatase inhibitor and possibly a CDK4/6 inhibitor.
Select...
I can swallow pills.
Select...
I am postmenopausal.
EMBER-3 Trial 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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PFS in the Estrogen Receptor 1 (ESR1)-mutation Detected Population
Progression Free Survival (PFS) in the Intent-to-Treat (IIT) Population
Secondary outcome measures
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 moreEMBER-3 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
~1710
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,618 Previous Clinical Trials
3,200,700 Total Patients Enrolled
64 Trials studying Breast Cancer
36,904 Patients Enrolled for Breast Cancer
Study DirectorEli Lilly and Company
1,347 Previous Clinical Trials
404,894 Total Patients Enrolled
21 Trials studying Breast Cancer
10,608 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously been treated with specific cancer therapies, excluding early-stage chemotherapy.My cancer has spread to my organs, lungs, or brain/spinal cord linings.My breast cancer is ER+ and HER2-, and has spread beyond the breast.My cancer progressed after treatment with an aromatase inhibitor and possibly a CDK4/6 inhibitor.My kidney, blood, and liver functions are all within normal ranges.You have a disease that can be measured or evaluated using specific criteria.I am fully active or restricted in physically strenuous activity but can do light work.My cancer progressed after treatment with an aromatase inhibitor and possibly a CDK4/6 inhibitor.I am considered a good candidate for hormone therapy.I have brain metastasis that is causing symptoms or has not been treated.I can swallow pills.I am postmenopausal.I have previously been treated with a CDK4/6 inhibitor, as it was approved and covered by insurance.
Research Study Groups:
This trial has the following groups:- Group 1: Imlunestrant
- Group 2: Investigator's Choice of Endocrine Therapy
- Group 3: Imlunestrant plus Abemaciclib
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Breast Cancer Patient Testimony for trial: Trial Name: NCT04975308 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many subjects are enrolled in this experiment?
"Indeed, the online clinical trials registry shows that this research is actively seeking participants. The listing was first made on October 4th, 2021 and has since been edited on October 19th, 2022. Currently, 55 different medical centres are looking to enroll a total of 800 patients."
Answered by AI
Are patients currently able to join this clinical trial?
"Yes, you are correct. The clinical trial is looking for 800 participants and is currently recruiting at 55 different locations."
Answered by AI
Has LY3484356 received the go-ahead from the FDA?
"There is available data that suggests LY3484356 is efficacious and safe, so it received a score of 3."
Answered by AI
What indications does LY3484356 typically treat?
"LY3484356 is frequently used as an intervention to prevent disease progression. It can also be administered to treat conditions like 2-3 years of tamoxifen therapy, high risk of recurrence, postmenopause."
Answered by AI
Is there any precedence for LY3484356 research?
"The drug LY3484356 was first studied in 2003 at Rebecca and John Moores UCSD Cancer Center. Out of the 256 trials that are currently recruiting patients, 203 have already been completed. A large portion of these clinical studies are taking place in Plano, Ohio."
Answered by AI
What are the most important goals of this clinical trial?
"The main focus of this clinical trial, which will last up to 3 years, is the Progression Free Survival (PFS) of patients in the Intent-to-Treat population. Additionally, researchers are looking at data surrounding Overall Survival and Pharmacokinetics with the aim of better understanding LY3484356's effects on disease progression."
Answered by AI
Who else is applying?
What state do they live in?
California
Arizona
What site did they apply to?
Banner MD Anderson Cancer Center
Banner MD Anderson Cancer Center at McKee Medical Center
University of California, Davis - Health Systems
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I am looking for a third line of treatment that is not chemotherapy
I have taken Ibrance and Fulvestrant with ipataserib on a clinical trial now progressing.
PatientReceived no prior treatments
I have looked into this trial and I think I am a good candidate to help doctors learn more about effective medications to help treat and prevent breast cancer recurrence.
PatientReceived no prior treatments
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