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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 able to swallow capsules
Participants with ER+/HER2- breast cancer enrolled in this study must have had evidence of clinical benefit while on endocrine therapy for at least 24 months in the adjuvant setting or at least 6 months in the advanced/metastatic setting or have untreated de novo metastatic breast cancer
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
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I can swallow pills.
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I have ER+/HER2- breast cancer and responded well to hormone therapy, or I have untreated advanced breast cancer.
Select...
I am willing to provide samples of my previously collected tissue.
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My organs are functioning well.

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
~1550
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
2,605 Previous Clinical Trials
3,199,170 Total Patients Enrolled
63 Trials studying Breast Cancer
36,404 Patients Enrolled for Breast Cancer
Study DirectorEli Lilly and Company
1,338 Previous Clinical Trials
403,345 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

Frequently Asked Questions

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

Is there any precedent regarding the use of LY3484356 in previous experiments?

"Currently, there are 387 active studies assessing the efficacy of LY3484356 with 85 being in Phase 3. Although Seattle, Washington is home to most clinical trials for LY3484356 , a total 23728 locations nationwide offers these research opportunities."

Answered by AI

What adverse effects does LY3484356 pose for human health?

"Taking into account the current level of evidence, our experts evaluated LY3484356's safety at a 1 on the scale due to this being an early phase trial with limited data in regards to efficacy and risk."

Answered by AI

Are there any available spots for participants in this exploration?

"Affirmative. Records available on clinicaltrials.gov suggest that this medical research is still recruiting patients, with the initial post dating back to December 10th 2019 and the last update taking place on November 23rd 2022. 500 individuals are sought from 49 distinct trial sites."

Answered by AI

In what geographic areas can participants access this trial?

"The ongoing recruitment of participants for this trial is taking place at 49 diverse medical centres. These include sites in San Francisco, Portland and Jacksonville; there are also 46 other locations to choose from. Selecting the closest centre should help minimise any travel burdens if you opt into the study."

Answered by AI

What is the capacity of this research project in terms of patient participants?

"To execute this trial, the sponsor - Eli Lilly and Company - needs to identify 500 eligible candidates. These research participants will be enrolled in locations such as Univ of California San Francisco (San Francisco) or OHSU Center for Health and Healing (Portland)."

Answered by AI

What are LY3484356's primary therapeutic applications?

"LY3484356 can be utilised to treat transplant rejection, kidney disorders, Waldenström Macroglobulinemia and pulmonary conditions."

Answered by AI
~95 spots leftby Mar 2025