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New oral drug aims to tackle Hormone-Driven cancers

NCT ID NCT04188548

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug, imlunestrant, in people with advanced or metastatic breast cancer that is estrogen-receptor positive (ER+), as well as certain other cancers like endometrial cancer. The drug is given alone or combined with other anticancer therapies. The main goals are to check safety, find the right dose, and see how the body processes the drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Imlunestrant (LY3484356)
What this could lead to
If successful, this could offer a new oral treatment option for people with ER+ breast cancer or endometrial cancer that has spread.
What could go wrong
This is an early-phase trial focused on safety and dosing, so effectiveness is not yet proven. Side effects or lack of benefit may limit further development.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

379 people

The number who actually took part.

Started

Dec 2019

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm endometrial cancer endometrial carcinoma endometrium neoplasm estrogen-receptor positive breast cancer triple-positive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced breast cancer Breast cancer Endometrial cancer Metastatic breast cancer

Contacts and locations

Locations

  • Antwerp University Hospital

    Edegem, Antwerpen, 2650, Belgium

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea

  • Asante Rogue Regional Medical Center

    Medford, Oregon, 97504, United States

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211, United States

  • Breast Cancer Research Centre-WA

    Nedlands, Western Australia, 6009, Australia

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298, Australia

  • Cancer Research SA

    Adelaide, South Australia, 5000, Australia

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Community Cancer Center North

    Indianapolis, Indiana, 46250, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Fundación Instituto Valenciano de Oncología

    Valencia, 46009, Spain

  • Highlands Oncology Group

    Springdale, Arkansas, 72762, United States

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [Cataluña], 08036, Spain

  • Hospital Clínico Universitario de Valencia

    Valencia, Valenciana, Comunitat, 46010, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28009, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040, Spain

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hyogo Cancer Center

    Akashi, Hyōgo, 673-8558, Japan

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031, United States

  • Institut Curie

    Paris, 75248, France

  • Institut Jules Bordet

    Anderlecht, Bruxelles-Capitale, Région de, 1070, Belgium

  • Institut de cancérologie Strasbourg Europe (ICANS)

    Strasbourg, 67033, France

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 80756, Taiwan

  • Lake Nona DDU

    Orlando, Florida, 32827, United States

  • Linear Clinical Research

    Nedlands, Western Australia, 6009, Australia

  • Mackay Memorial Hospital

    Taipei, 10449, Taiwan

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic in Arizona - Phoenix

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224, United States

  • Memorial Sloan Kettering - Bergen

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Minnesota Oncology/Hematology PA

    Minneapolis, Minnesota, 55404, United States

  • Minnesota Oncology/Hematology PA

    The Woodlands, Texas, 77380, United States

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cheng-Kung Uni. Hosp.

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    Taipei, 10055, Taiwan

  • Ohio State University Medical Center

    Columbus, Ohio, 43210, United States

  • Oncology and Hematology Associates of Southwest Virginia Inc

    The Woodlands, Texas, 77380, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • Seoul National University Hospital

    Seoul, Seoul, Korea, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, Korea, 03722, South Korea

  • South Texas Accelerated Research Therapeutics (START)

    San Antonio, Texas, 78229-3307, United States

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010, Australia

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tennessee Oncology Nashville

    Nashville, Tennessee, 37203, United States

  • Texas Oncology - San Antonio Medical Center

    The Woodlands, Texas, 77380, United States

  • Texas Oncology - Tyler

    Tyler, Texas, 75702, United States

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 77380, United States

  • The University of Vermont Medical Center Inc.

    Burlington, Vermont, 05401, United States

  • UCSF Medical Center at Mission Bay

    San Francisco, California, 94158, United States

  • UPMC Hillman Cancer Center Harrisburg

    Harrisburg, Pennsylvania, 17109, United States

  • US Oncology

    The Woodlands, Texas, 77380, United States

  • USO-Rocky Mountain Cancer Center

    The Woodlands, Texas, 77380, United States

  • UT Southwestern Med Center

    Dallas, Texas, 75390-9179, United States

  • UZ Leuven

    Leuven, Vlaams-Brabant, 3000, Belgium

  • University of California, Irvine

    Orange, California, 92868, United States

  • University of Oklahoma Health Sciences Center, Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030-4009, United States

  • Vanderbilt Health One Hundred Oaks

    Nashville, Tennessee, 37067, United States

  • Washington University

    St Louis, Missouri, 63110, United States

  • Wilmot Cancer Institute

    Rochester, New York, 14642, United States

  • Winship Cancer Center Emory University

    Atlanta, Georgia, 30322, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.