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Selective Estrogen Receptor Downregulator (SERD)

Imlunestrant for Early Breast Cancer (EMBER-4 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- early-stage, resected, invasive breast cancer without evidence of distant metastasis.
Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization to death from any cause (up to 10 years)
Awards & highlights

EMBER-4 Trial Summary

This trial is testing whether immunestrant works better than standard hormone therapy for people with early breast cancer who are estrogen receptor positive and human epidermal receptor 2 negative.

Who is the study for?
This trial is for people with early-stage breast cancer that's ER+ and HER2-, who've finished 2-5 years of hormone therapy but still have a high risk of the cancer coming back. They should be in good health, not have had certain other cancers or gaps in their previous treatment, and can't be pregnant or planning to become so during the study.Check my eligibility
What is being tested?
The trial tests Imlunestrant against standard endocrine therapies like Tamoxifen, Anastrozole, Letrozole, and Exemestane. It aims to see if Imlunestrant is more effective for those at higher risk of breast cancer recurrence after initial hormone therapy.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones from endocrine therapies may include hot flashes, fatigue, joint pain, mood swings, decreased sex drive and bone thinning. The new drug's side effects will be monitored closely.

EMBER-4 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My breast cancer is early-stage, ER+ and HER2-, with no distant spread.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.

EMBER-4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization to death from any cause (up to 10 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization to death from any cause (up to 10 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
Invasive Disease-Free Survival (IDFS)
Secondary outcome measures
Change from Baseline in the EORTC QLQ-C30 Global QOL
Change from Baseline in the EORTC QLQ-C30 Role Functioning
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning
+4 more

EMBER-4 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ImlunestrantExperimental Treatment1 Intervention
Imlunestrant administered orally.
Group II: Investigator's Choice of Endocrine TherapyActive Control4 Interventions
Investigator's choice of tamoxifen, anastrozole, letrozole, or exemestane administered per local approved label.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imlunestrant
2022
Completed Phase 1
~170

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,618 Previous Clinical Trials
3,195,517 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
399,711 Total Patients Enrolled
21 Trials studying Breast Cancer
10,608 Patients Enrolled for Breast Cancer

Media Library

Imlunestrant (Selective Estrogen Receptor Downregulator (SERD)) Clinical Trial Eligibility Overview. Trial Name: NCT05514054 — Phase 3
Breast Cancer Research Study Groups: Investigator's Choice of Endocrine Therapy, Imlunestrant
Breast Cancer Clinical Trial 2023: Imlunestrant Highlights & Side Effects. Trial Name: NCT05514054 — Phase 3
Imlunestrant (Selective Estrogen Receptor Downregulator (SERD)) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05514054 — Phase 3
Breast Cancer Patient Testimony for trial: Trial Name: NCT05514054 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people with the prescribed illness sign up for this test currently?

"That is correct, the public information available on clinicaltrials.gov affirms that this trial is looking for more patients as of 11/9/2022. This particular study was first posted on 10/4/2022 and 100 sites are needed to reach their goal of 6000 participants."

Answered by AI

How many participants will this research project be able to accommodate?

"That is correct, the information available on clinicaltrials.gov affirms that this study is still looking for volunteers. The trial was first advertised on October 4th of 2020 and has been updated as recently as November 9th, 2020. They are hoping to enroll 6000 individuals from 100 different locations."

Answered by AI

Has the food and drug administration given Imlunestrant their seal of approval?

"Imlunestrant's safety is based on past clinical trials, and it received a score of 3."

Answered by AI

Does this research have a broad geographic distribution in North America?

"Banner MD Anderson Cancer Center at McKee Medical Center in Loveland, Colorado, St. Joseph Hospital in Orange, California and Oregon Health and Science University in Portland, Oregon are all running this clinical trial with an additional 100 other medical centres."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
Arizona
Tennessee
How many prior treatments have patients received?
1
2
What site did they apply to?
Sarah Cannon Research Institute SCRI
Winship Cancer Institute, Emory University
Millennium Oncology - Hollywood

Why did patients apply to this trial?

Looking for better healgh for me, thank u. I have stage IV cancer and a daughter that works in clinical trials. I'd like to start a trial ASAP.
PatientReceived 1 prior treatment
I was unsure of a couple of questions. My 24 months is coming up in March 2023. I am very interested in this study to see if the medication helps myself, others with breast cancer. I am open to the rules for the trial and can commit to the terms. Thank you,.
PatientReceived 1 prior treatment
~4000 spots leftby Oct 2027