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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

Must not have

Participants must not have cancer of the central nervous system that is unstable

Participants must not have certain infections such as hepatitis or tuberculosis or HIV that are not well controlled

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through measured progressive disease (estimated up to 28 months)

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to provide samples of my previously collected tissue.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My brain or spinal cord cancer is stable.

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I do not have uncontrolled hepatitis, tuberculosis, or HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through measured progressive disease (estimated up to 28 months)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Dose Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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