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Breast CancerPhase 1EMBERNCT04188548

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

A Phase 1 study testing LY3484356, Abemaciclib and Everolimus in people with Breast Cancer and Advanced Breast Cancer, run by Eli Lilly and Company at 74 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
LY3484356, Abemaciclib and Everolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
379 participants
Where
74 sitesin 8 countries
Study dates
10 Dec 2019to Dec 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 17Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

74 sites in 8 countries.

74 sites in 8 countries

United States42 sites

  • Winship Cancer Center Emory University

    Atlanta, Georgia, 30322

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • The University of Vermont Medical Center Inc.

    Burlington, Vermont, 05401

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Memorial Sloan Kettering Cancer Center

    Commack, New York, 11725

  • UT Southwestern Med Center

    Dallas, Texas, 75390-9179

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 77380

  • Duke University

    Durham, North Carolina, 27710

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • UPMC Hillman Cancer Center Harrisburg

    Harrisburg, Pennsylvania, 17109

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Community Cancer Center North

    Indianapolis, Indiana, 46250

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

  • Asante Rogue Regional Medical Center

    Medford, Oregon, 97504

  • Minnesota Oncology/Hematology PA

    Minneapolis, Minnesota, 55404

  • Memorial Sloan Kettering - Bergen

    Montvale, New Jersey, 07645

  • Vanderbilt Health One Hundred Oaks

    Nashville, Tennessee, 37067

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • Tennessee Oncology Nashville

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Oklahoma Health Sciences Center, Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • University of California, Irvine

    Orange, California, 92868

  • Lake Nona DDU

    Orlando, Florida, 32827

  • Mayo Clinic in Arizona - Phoenix

    Phoenix, Arizona, 85054

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Wilmot Cancer Institute

    Rochester, New York, 14642

  • South Texas Accelerated Research Therapeutics (START)

    San Antonio, Texas, 78229-3307

  • UCSF Medical Center at Mission Bay

    San Francisco, California, 94158

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

  • Washington University

    St Louis, Missouri, 63110

  • Minnesota Oncology/Hematology PA

    The Woodlands, Texas, 77380

  • Oncology and Hematology Associates of Southwest Virginia Inc

    The Woodlands, Texas, 77380

  • Texas Oncology - San Antonio Medical Center

    The Woodlands, Texas, 77380

  • US Oncology

    The Woodlands, Texas, 77380

  • USO-Rocky Mountain Cancer Center

    The Woodlands, Texas, 77380

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

Other trials in United States

Spain10 sites

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [Cataluña], 08036

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28009

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Hospital Clínico Universitario de Valencia

    Valencia, Valenciana, Comunitat, 46010

  • Fundación Instituto Valenciano de Oncología

    Valencia, 46009

Other trials in Spain

Taiwan6 sites

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 80756

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng-Kung Uni. Hosp.

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 10055

  • Mackay Memorial Hospital

    Taipei, 10449

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Australia5 sites

  • Cancer Research SA

    Adelaide, South Australia, 5000

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Breast Cancer Research Centre-WA

    Nedlands, Western Australia, 6009

  • Linear Clinical Research

    Nedlands, Western Australia, 6009

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

Other trials in Australia

South Korea4 sites

  • Severance Hospital, Yonsei University Health System

    Seoul, Korea, 03722

  • Seoul National University Hospital

    Seoul, Seoul, Korea, 03080

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Belgium3 sites

  • Institut Jules Bordet

    Anderlecht, Bruxelles-Capitale, Région de, 1070

  • Antwerp University Hospital

    Edegem, Antwerpen, 2650

  • UZ Leuven

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

France2 sites

  • Institut Curie

    Paris, 75248

  • Institut de cancérologie Strasbourg Europe (ICANS)

    Strasbourg, 67033

Other trials in France

Japan2 sites

  • Hyogo Cancer Center

    Akashi, Hyōgo, 673-8558

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

Other trials in Japan

About this study

Official 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

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.

Being tested
LY3484356, Abemaciclib, Everolimus, Alpelisib, Trastuzumab
Medical subject headings
Breast Neoplasms, Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3484356Drug

    Also called Imlunestrant

    Administered orally

  • AbemaciclibDrug

    Also called LY2835219

    Administered orally

  • EverolimusDrug

    Administered orally

  • AlpelisibDrug

    Administered orally

  • TrastuzumabDrug

    Administered intravenously

  • Aromatase Inhibitor (AI)Drug

    Anastrozole or Exemestane or Letrozole administered orally (physician choice)

  • PertuzumabDrug

    Administered intravenously

Study groups in NCT04188548
Study groupRoleWhat they receive
Dose Escalation LY3484356ExperimentalLY3484356 given orally.
Receives: Drug: LY3484356
Part A: Dose Expansion: LY3484356 + Abemaciclib +/- AIExperimentalLY3484356 and abemaciclib given orally in combination with or without Aromatase Inhibitor (AI) of physician's choice (Anastrozole, Exemestane, or Letrozole) administered orally.
Receives: Drug: LY3484356; Drug: Abemaciclib; Drug: Aromatase Inhibitor (AI)
Part B: Dose Expansion: Cohort E3: LY3484356ExperimentalLY3484356 given orally.
Receives: Drug: LY3484356
Part B: Dose Expansion: Cohort E4: LY3484356 + EverolimusExperimentalLY3484356 and everolimus given orally.
Receives: Drug: LY3484356; Drug: Everolimus
Part B: Dose Expansion: Cohort E5: LY3484356 + AlpelisibExperimentalLY3484356 and alpelisib given orally.
Receives: Drug: LY3484356; Drug: Alpelisib
Part C:Dose Expansion: LY3484356 + Trastuzumab +/- AbemaciclibExperimentalLY3484356 administered orally in combination with trastuzumab intravenously with or without Abemaciclib.
Receives: Drug: LY3484356; Drug: Abemaciclib; Drug: Trastuzumab
Part D: Dose Expansion: LY3484356 +/- AbemaciclibExperimentalLY3484356 and Abemaciclib given orally with trastuzumab administered intravenously.
Receives: Drug: LY3484356; Drug: Abemaciclib
Part E: Dose Expansion: LY3484356 + Trastuzumab + PertuzumabExperimentalLY3484356 administered orally in combination with trastuzumab and pertuzumab administered intravenously.
Receives: Drug: LY3484356; Drug: Trastuzumab; Drug: Pertuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Number of Participants with DLTs and DLT-Equivalent Toxicities

    Measured: Baseline through Cycle 1 (21/28 Day Cycle)

Secondary outcomes (9)

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

    PK: AUC of LY3484356

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

  2. PK: Maximum Concentration (Cmax) of LY3484356

    PK: Cmax of LY3484356

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

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

    PK: AUC of LY3484356 in Combination with Other Anticancer Therapies

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

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

    PK: Cmax of LY3484356 in Combination with Other Anticancer Therapies

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

  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

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

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

  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

    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

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

  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

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

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

  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

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

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

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2019
  2. Study start10 Dec 2019
  3. Primary completion29 Jun 2020
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
379 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04188548
Sponsor's protocol ID
17502
Other IDs
J2J-MC-JZLA, 2019-003581-41, 2019
Acronym
EMBER
Status last verified
Jun 2026
First submitted
18 Nov 2019
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bhave M, Jhaveri KL, Kaufman PA, Aftimos P, Lombard J, Giridhar KV, Im SA, Ma CX, Lee KT, Kim SB, Sohn J, Li Y, Yuen E, Estrem ST, Nguyen B, Makena MR, Ismail-Khan R, Beeram M. Imlunestrant, an oral selective estrogen receptor degrader, in combination with HER2 directed therapy, with or without abemaciclib, in ER-positive, HER2-positive advanced breast cancer: results from the phase 1a/1b EMBER study. Breast Cancer Res. 2025 Dec 21;28(1):18. doi: 10.1186/s13058-025-02168-6.

    PubMed 41423595

  • Jhaveri KL, Lim E, Jeselsohn R, Ma CX, Hamilton EP, Osborne C, Bhave M, Kaufman PA, Beck JT, Manso Sanchez L, Parajuli R, Wang HC, Tao JJ, Im SA, Harnden K, Yonemori K, Dhakal A, Neven P, Aftimos P, Pierga JY, Lu YS, Larson T, Jerez Y, Sideras K, Sohn J, Kim SB, Saura C, Bardia A, Sammons SL, Bacchion F, Li Y, Yuen E, Estrem ST, Rodrik-Outmezguine V, Nguyen B, Ismail-Khan R, Smyth L, Beeram M. Imlunestrant, an Oral Selective Estrogen Receptor Degrader, as Monotherapy and in Combination With Targeted Therapy in Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Phase Ia/Ib EMBER Study. J Clin Oncol. 2024 Dec 10;42(35):4173-4186. doi: 10.1200/JCO.23.02733. Epub 2024 Sep 6.

    PubMed 39241211

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3484356, Abemaciclib and Everolimus in people with Breast Cancer and Advanced Breast Cancer, run by Eli Lilly and Company at 74 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Spain, Taiwan, Australia, South Korea and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Dose Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities (time frame: Baseline through Cycle 1 (21/28 Day Cycle)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04188548, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.

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EMBER Clinical Trial NCT04188548 | AzTrials