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Aromatase Inhibitor

Imlunestrant + Endocrine Therapy + Abemaciclib for Advanced 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
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Uprandomization until death from any cause (estimated as up to 5 years)
Awards & highlights
Pivotal Trial
No Placebo-Only Group

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.

Eligible Conditions
  • Breast Cancer
  • Cancer

EMBER-3 Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You are suitable for treatment with hormone therapy.
Select...
You can swallow pills.
Select...
You are eligible for treatment with hormone therapy.
Select...
You have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer.

EMBER-3 Trial Timeline

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

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 more

Awards & Highlights

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.

EMBER-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
~140
Abemaciclib
2019
Completed Phase 2
~1440

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,564 Previous Clinical Trials
3,179,967 Total Patients Enrolled
64 Trials studying Breast Cancer
36,904 Patients Enrolled for Breast Cancer
Study DirectorEli Lilly and Company
1,319 Previous Clinical Trials
398,521 Total Patients Enrolled
21 Trials studying Breast Cancer
10,608 Patients Enrolled for Breast Cancer

Media Library

Exemestane (Aromatase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04975308 — Phase 3
Breast Cancer Research Study Groups: Imlunestrant, Investigator's Choice of Endocrine Therapy, Imlunestrant plus Abemaciclib
Breast Cancer Clinical Trial 2023: Exemestane Highlights & Side Effects. Trial Name: NCT04975308 — Phase 3
Exemestane (Aromatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04975308 — Phase 3
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 research facilities are conducting this investigation?

"So far, 55 patients have enrolled in this trial at locations such as Texas Oncologys Texas Oncology-Plano East in Plano, Aultman Hospital in Canton, and Texas Oncology - San Antonio Medical Center in San Antonio."

Answered by AI

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
University of California, Davis - Health Systems
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

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
Recent research and studies
clinicaltrials.govStudy
A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer
2021. "A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04975308.
All > Breast Cancer Austin > Colorado
~143 spots leftby Apr 2024
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