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LY3484356 for Breast Cancer (EMBER Trial)

Phase 1
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
Participants must be willing to provide adequate archival tissue sample
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through measured progressive disease (estimated up to 28 months)
Awards & highlights

EMBER Trial Summary

This trial will test if a new drug is safe and effective for treating people with advanced breast or endometrial cancer.

Who is the study for?
This trial is for adults with advanced or metastatic breast or endometrial cancer. They must be able to swallow pills, have good organ function, and provide a tissue sample. Women should not be pregnant and must use effective birth control. Those with ER+/HER2- breast cancer should have seen benefits from prior hormone therapy.Check my eligibility
What is being tested?
The study tests LY3484356 alone or combined with other cancer drugs (Trastuzumab, Aromatase Inhibitor, Pertuzumab, Abemaciclib, Everolimus, Alpelisib) to evaluate safety and effectiveness against advanced breast or endometrial cancers.See study design
What are the potential side effects?
Possible side effects include reactions at the drug infusion site, hormonal imbalances due to aromatase inhibitors, heart issues from Trastuzumab/Pertuzumab, liver/kidney problems from Everolimus/Alpelisib and blood cell count changes due to Abemaciclib.

EMBER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am willing to provide samples of my previously collected tissue.

EMBER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through measured progressive disease (estimated up to 28 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through measured progressive disease (estimated up to 28 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Dose Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities
Secondary outcome measures
Clinical Benefit Rate (CBR): Percentage of Participants with a BOR of CR or PR, or SD lasting ≥24 weeks as per RECIST v1.1
Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response (BOR) of CR, PR, and Stable Disease (SD) as per RECIST v1.1
Duration of Response (DoR): Time From the Date of First Evidence of CR, PR (per RESIST v1.1) to the Date of Objective Progression or Death Due to Any Cause, Whichever is Earlier
+6 more

EMBER Trial Design

8Treatment groups
Experimental Treatment
Group I: Part E: Dose Expansion: LY3484356 + Trastuzumab + PertuzumabExperimental Treatment3 Interventions
LY3484356 administered orally in combination with trastuzumab and pertuzumab administered intravenously.
Group II: Part D: Dose Expansion: LY3484356 +/- AbemaciclibExperimental Treatment2 Interventions
LY3484356 and Abemaciclib given orally with trastuzumab administered intravenously.
Group III: Part C:Dose Expansion: LY3484356 + Trastuzumab +/- AbemaciclibExperimental Treatment3 Interventions
LY3484356 administered orally in combination with trastuzumab intravenously with or without Abemaciclib.
Group IV: Part B: Dose Expansion: Cohort E5: LY3484356 + AlpelisibExperimental Treatment2 Interventions
LY3484356 and alpelisib given orally.
Group V: Part B: Dose Expansion: Cohort E4: LY3484356 + EverolimusExperimental Treatment2 Interventions
LY3484356 and everolimus given orally.
Group VI: Part B: Dose Expansion: Cohort E3: LY3484356Experimental Treatment1 Intervention
LY3484356 given orally.
Group VII: Part A: Dose Expansion: LY3484356 + Abemaciclib +/- AIExperimental Treatment3 Interventions
LY3484356 and abemaciclib given orally in combination with or without Aromatase Inhibitor (AI) of physician's choice (Anastrozole, Exemestane, or Letrozole) administered orally.
Group VIII: Dose Escalation LY3484356Experimental Treatment1 Intervention
LY3484356 given orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3484356
2021
Completed Phase 1
~190
Trastuzumab
2014
Completed Phase 4
~5190
Pertuzumab
2014
Completed Phase 3
~7500
Abemaciclib
2019
Completed Phase 2
~1710
Everolimus
2010
Completed Phase 4
~1510
Alpelisib
2018
Completed Phase 3
~900

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,624 Previous Clinical Trials
3,216,421 Total Patients Enrolled
63 Trials studying Breast Cancer
36,404 Patients Enrolled for Breast Cancer
Study DirectorEli Lilly and Company
1,349 Previous Clinical Trials
415,180 Total Patients Enrolled
20 Trials studying Breast Cancer
10,108 Patients Enrolled for Breast Cancer

Media Library

LY3484356 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04188548 — Phase 1
Breast Cancer Research Study Groups: Part D: Dose Expansion: LY3484356 +/- Abemaciclib, Part B: Dose Expansion: Cohort E5: LY3484356 + Alpelisib, Part C:Dose Expansion: LY3484356 + Trastuzumab +/- Abemaciclib, Dose Escalation LY3484356, Part B: Dose Expansion: Cohort E3: LY3484356, Part E: Dose Expansion: LY3484356 + Trastuzumab + Pertuzumab, Part A: Dose Expansion: LY3484356 + Abemaciclib +/- AI, Part B: Dose Expansion: Cohort E4: LY3484356 + Everolimus
Breast Cancer Clinical Trial 2023: LY3484356 Highlights & Side Effects. Trial Name: NCT04188548 — Phase 1
LY3484356 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04188548 — Phase 1
~92 spots leftby Jun 2025
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