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Active, Not Recruiting

NCT Number: NCT04188548

A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer

The reason for this study is to see if the study drug LY3484356 alone or in combination with other anticancer therapies is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All study parts:

  • Participants must be willing to provide adequate archival tissue sample
  • Participants must be willing to use highly effective birth control
  • Participants must have adequate organ function
  • Participants must be able to swallow capsules

Dose escalation- Participants must have one of the following:

  • Parts A and B: ER+ HER2- breast cancer with evidence of locally advanced unresectable or metastatic disease who have had the following:
  • Part A: may have had up to 1 prior regimen of any kind for in the advanced/metastatic setting and no prior cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.
  • Part B: may have had up to 2 prior regimens, no more than 1 of which may be endocrine therapy in the advanced/metastatic setting, and must have received a prior CDK4/6 inhibitor
  • Cohort E4: No prior everolimus.
  • Cohort E5: No prior alpelisib and must have a phosphatidylinositol 3-kinase catalytic α (PIK3Cα) mutation as determined by local testing.
  • Part C: ER+, human epidermal growth factor receptor 2 positive (HER2+) breast cancer with evidence of locally advanced unresectable or metastatic disease who have had at least 2 HER2-directed therapies in any setting.
  • Part D: ER+, EEC that has progressed after platinum containing chemotherapy and no prior fulvestrant or aromatase inhibitor therapy.
  • Part E: ER+ and HER2+ breast cancer with evidence of locally advanced, unresectable, or metastatic disease.
  • Part E: Participants must have received induction taxane chemotherapy combined with trastuzumab + pertuzumab as first-line treatment for advanced/metastatic disease and must not have progressed on this regimen.
  • Part E: Participants must not have received more than 1 HER2-directed regimen or any endocrine therapy for advanced disease or any prior CDK4/6 inhibitor therapy.

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

Exclusion criteria

  • Participants must not have certain infections such as hepatitis or tuberculosis or HIV that are not well controlled
  • Participants must not have another serious medical condition
  • Participants must not have cancer of the central nervous system that is unstable
  • Participants must not be pregnant or breastfeeding

Treatment and study plan

LY3484356

Drug

Administered orally

Other names: Imlunestrant

Abemaciclib

Drug

Administered orally

Other names: LY2835219

Everolimus

Drug

Administered orally

Alpelisib

Drug

Administered orally

Trastuzumab

Drug

Administered intravenously

Aromatase Inhibitor (AI)

Drug

Anastrozole or Exemestane or Letrozole administered orally (physician choice)

Pertuzumab

Drug

Administered intravenously

Primary outcomes

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

    Time frame: Baseline through Cycle 1 (21/28 Day Cycle)

    Number of Participants with DLTs and DLT-Equivalent Toxicities

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3484356

    Time frame: Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (21/28 Day Cycles)

    PK: AUC of LY3484356

  2. PK: Maximum Concentration (Cmax) of LY3484356

    Time frame: Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (21/28 Day Cycles)

    PK: Cmax of LY3484356

  3. PK: AUC of LY3484356 in Combination with Other Anticancer Therapies

    Time frame: Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (21/28 Day Cycles)

    PK: AUC of LY3484356 in Combination with Other Anticancer Therapies

  4. PK: Cmax of LY3484356 in Combination with Other Anticancer Therapies

    Time frame: Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (21/28 Day Cycles)

    PK: Cmax of LY3484356 in Combination with Other Anticancer Therapies

  5. Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Time frame: Baseline through Disease Progression or Death (Estimated up to 28 Months)

    ORR: Percentage of Participants with Confirmed CR or PR as per RECIST v1.1

  6. 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

    Time frame: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 28 Months)

    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

  7. 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

    Time frame: Baseline through Measured Progressive Disease (Estimated up to 28 Months)

    DCR: Percentage of Participants with a BOR of CR, PR, and SD as per RECIST v1.1

  8. Clinical Benefit Rate (CBR): Percentage of Participants with a BOR of CR or PR, or SD lasting ≥24 weeks as per RECIST v1.1

    Time frame: Baseline through Measured Progressive Disease (Estimated up to 28 Months)

    CBR: Percentage of Participants with a BOR of CR or PR, or SD lasting ≥24 weeks as per RECIST v1.1

  9. Progression Free Survival (PFS): Time From Baseline to the Date of Objective Progression or Death Due to Any Cause, Whichever is Earlier

    Time frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 28 Months)

    PFS: Time From Baseline to the Date of Objective Progression or Death Due to Any Cause, Whichever is Earlier

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

EMBER: A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With ER+ Locally Advanced or Metastatic Breast Cancer and Other Select Non-Breast Cancers

Acronym: EMBER

Important dates

Study start
2019
Primary completion
2020
Study completion
2027
First posted
Dec 6, 2019
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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