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Breast NeoplasmsPhase 2preEMBERNCT07287098

A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer

A Phase 2 study testing Imlunestrant, Goserelin and Tamoxifen 20 mg in people with Breast Neoplasms, run by Eli Lilly and Company at 90 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study will include two groups of patients: Cohort 1 and Cohort 2. Cohort 1: will help researchers learn how a medicine called imlunestrant (LY3484356) affects a specific type of breast cancer. Some patients will take both imlunestrant and another treatment to suppress their ovarian function. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
Imlunestrant, Goserelin and Tamoxifen 20 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
90 sitesin 7 countries
Study dates
13 May 2026to Dec 2029
Phase
Phase 2
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cohort 1:
  • Have histologically confirmed Stage I to III Estrogen Receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) invasive breast carcinoma with Ki-67 at least 10%
  • Be willing and able to provide pre- and on-treatment tumor samples.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Be able to swallow capsules or tablets.
  • Be premenopausal women.
Show all 17Show fewer
  • If of childbearing potential must use 1 highly effective method of non-hormonal contraception while receiving study treatment and for the duration specified in protocol.
  • Have adequate organ function.
  • Cohort 2:
  • Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis
  • Have undergone definitive loco-regional therapy.
  • Have received at least 4.5 years of any adjuvant endocrine therapy (ET), or at least 2 years of adjuvant ET with no additional ovarian suppression planned.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Be able to swallow capsules or tablets.
  • Be premenopausal women
  • If of childbearing potential must use 1 highly effective method of non-hormonal contraception while receiving study treatment and for the duration specified in protocol.
  • Have adequate organ function.

Who cannot join

  • Cohort 1:
  • Have bilateral invasive metastatic, occult primary, or inflammatory breast cancer.
  • Have had prior bilateral oophorectomy or ovarian ablation.
  • Have a serious medical condition
  • Had major surgery within 28 days prior to randomization.
  • Have a history of other cancer (except non melanoma skin cancer, Stage I uterine cancer, or carcinoma in situ of the cervix or other in situ cancer), unless in complete remission with no therapy for a minimum of 1 year.
Show all 22Show fewer
  • Plan to receive concurrent neoadjuvant therapy with any other non-protocol anticancer therapy.
  • Have had any prior therapy for an invasive or non-invasive breast cancer.
  • Have had prior radiotherapy to the ipsilateral chest wall for any malignancy.
  • Have received prior anti-estrogen therapy, including for osteoporosis or prevention of breast cancer.
  • Have had prior treatment with any Gonadotropin-releasing hormone (GnRH) agonist within 12 months prior to randomization.
  • Receiving current exogenous reproductive hormone therapy
  • Cohort 2:
  • Have ovarian cyst(s) greater than (>) 1 centimeter (cm) at screening.
  • Have metastatic occult primary, or inflammatory breast cancer.
  • Have had prior bilateral oophorectomy or ovarian ablation.
  • Have a serious medical condition
  • Had major surgery within 28 days prior to randomization.
  • Have a history of other cancer (except non melanoma skin cancer or carcinoma in situ of the cervix or other in situ cancer), unless in complete remission with no therapy for a minimum of 1 year.
  • Completed or discontinued prior adjuvant ET >6 months prior to screening.
  • Have received prior therapy with any selective estrogen receptor degrader (SERD).
  • Receiving current exogenous reproductive hormone therapy.

Trial locations and contacts

90 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact

1-317-615-4559

LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact contact

clinical_inquiry_hub@lilly.com

90 sites in 7 countries

United States37 sites, 36 recruiting

  • AdventHealth Altamonte Springs

    Altamonte Springs, Florida, 32701

    Wassim Mchayleh

    Not yet recruiting

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

    Manali Bhave

    Not yet recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35205

    Erica Stringer-Reasor

    Not yet recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    617-726-6500

    Seth Wander

    Not yet recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    617-632-2335

    Erica Mayer

    Not yet recruiting

  • The University of Vermont Medical Center Inc.

    Burlington, Vermont, 05401

    Peter Kaufman

    Not yet recruiting

  • Ironwood Cancer & Research Centers

    Chandler, Arizona, 85224

    Sumeet Mendonca

    Not yet recruiting

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina, 27514

    Jeffrey Aldrich

    Not yet recruiting

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

    434-924-9333

    Trish Millard

    Recruiting

  • City of Hope, Chicago

    Chicago, Illinois, 60611

    Teja Poosarla

    Not yet recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Suspended

  • City of Hope

    Duarte, California, 91010

    Hope Rugo

    Not yet recruiting

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

    Jennifer Matro

    Recruiting

  • Banner MD Anderson Cancer Center at North Colorado Medical Center

    Greeley, Colorado, 80631

    970-810-3894

    Esther Mondo

    Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030-4009

    832-728-7423

    Taiwo Adesoye

    Recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Hanh Mai

    Not yet recruiting

  • Oncology Consultants P.A.

    Houston, Texas, 77030

    713-600-0900

    Ricardo Alvarez

    Recruiting

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

    Rina Yadav

    Recruiting

  • City of Hope Orange County Lennar Foundation Cancer Center

    Irvine, California, 92618

    Hope Rugo

    Not yet recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

    904-953-2000

    Rohit Rao

    Not yet recruiting

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536

    Ruta Arays

    Not yet recruiting

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    323-397-5954

    Daphne Stewart

    Recruiting

  • Banner MD Anderson Cancer Center at McKee Medical Center

    Loveland, Colorado, 80538

    970-810-3894

    Esther Mondo

    Recruiting

  • Tennessee Oncology

    Nashville, Tennessee, 37203

    Sara Nunnery

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Sherry Shen

    Not yet recruiting

  • City of Hope National Medical Center, Atlanta Cancer Center

    Newnan, Georgia, 30265

    Sarah Friend

    Not yet recruiting

  • Mayo Clinic in Arizona - Phoenix

    Phoenix, Arizona, 85054

    480-301-8000

    Shakeela Bahadur

    Not yet recruiting

  • City of Hope, Phoenix

    Phoenix, Arizona, 85338

    Cynthia Lynch

    Not yet recruiting

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    503-215-5696

    Alison Conlin

    Recruiting

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

    503-215-5696

    Alison Conlin

    Recruiting

  • Mayo Clinic in Rochester, Minnesota

    Rochester, Minnesota, 55905

    507-284-2511

    Matthew Goetz

    Not yet recruiting

  • Wilmot Cancer Institute

    Rochester, New York, 14642

    585-275-4823

    Ajay Dhakal

    Not yet recruiting

  • Baylor Scott & White Medical Center - Round Rock

    Round Rock, Texas, 78665

    512-509-0200

    Christal Murray

    Not yet recruiting

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

    801-585-0236

    Jairam Krishnamurthy

    Not yet recruiting

  • UCLA Hematology/Oncology - Parkside

    Santa Monica, California, 90404

    310-998-4747

    Nicholas McAndrew

    Not yet recruiting

  • New York Cancer and Blood Specialists

    Shirley, New York, 11967

    631-675-5075

    Richard Zuniga

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Rebecca Aft

    Not yet recruiting

Other trials in United States

Germany30 sites, 29 recruiting

  • Evangelisches Krankenhaus Bergisch Gladbach

    Bergisch Gladbach, 51465

    Christian Rudlowski

    Not yet recruiting

  • Praxis am Volkspark

    Berlin, 10715

    Jan-Piet Habbel

    Not yet recruiting

  • Onkologische Schwerpunktpraxis Bielefeld

    Bielefeld, 33604

    Siemke Steinke

    Recruiting

  • Augusta-Kranken-Anstalt

    Bochum, 44791

    Matthias Losch

    Not yet recruiting

  • Gynaekologisches Zentrum Bonn

    Bonn, 53111

    004922890927671

    Christian Kurbacher

    Not yet recruiting

  • Marienhospital Bottrop

    Bottrop, 46236

    4920411061601

    Hans-Christian Kolberg

    Not yet recruiting

  • Onkologisch - Hämatologische Schwerpunktpraxis

    Bremen, 28209

    Ralf Meyer

    Not yet recruiting

  • Medizinische Universität Lausitz- Carl Thiem

    Cottbus, 03048

    Suspended

  • Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf

    Dresden, 01307

    Thomas Illmer

    Not yet recruiting

  • Universitaetsklinikum Erlangen

    Erlangen, 91054

    +4991318533572

    Peter Fasching

    Recruiting

  • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung

    Essen, 45136

    +4920117433005

    Sherko Kümmel

    Not yet recruiting

  • Universitaetsklinikum Essen

    Essen, 45147

    Ann-Kathrin Bittner

    Not yet recruiting

  • Agaplesion Markus Krankenhaus

    Frankfurt, 60431

    00496995332228

    Marc Thill

    Not yet recruiting

  • Mammazentrum HH - Krankenhaus Jerusalem

    Hamburg, 20357

    00494044190670

    Anne-Sophie Adam

    Not yet recruiting

  • Praxisklinik Harburg

    Hamburg, 21073

    0049 40 303 754 25

    Christoph Grossmann

    Not yet recruiting

  • Frauenärzte am Bahnhofsplatz

    Hildesheim, 31134

    +49 (5121) 59 02 - 0

    Christoph Uleer

    Recruiting

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel

    Kiel, 24105

    +4943150021686

    Marion van Mackelenbergh

    Not yet recruiting

  • Evangelisches Krankenhaus Bethesda Mönchengladbach

    Mönchengladbach, 41061

    Katja Krauss

    Recruiting

  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen

    München, 80336

    004989440077581

    Nadia Harbeck

    Not yet recruiting

  • Rotkreuzklinikum München gemeinnützige GmbH

    München, 80637

    00498913033797

    Michael Braun

    Recruiting

  • Ruppiner Kliniken

    Neuruppin, 16816

    Verena Kiver

    Not yet recruiting

  • Klinikum Ernst von Bergmann

    Potsdam, 14467

    +4933124135643

    Dorothea Fischer

    Not yet recruiting

  • MVZ für Hämatologie und Onkologie Ravensburg GmbH - Studienzentrum

    Ravensburg, 88212

    Thomas Decker

    Not yet recruiting

  • Klinikum Mutterhaus der Borromäerinnen

    Trier, 54290

    Sebastian Jud

    Recruiting

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

    004970712982211

    Tobias Engler

    Not yet recruiting

  • Universitaetsklinikum Ulm

    Ulm, 89075

    004973150058531

    Henning Schäffler

    Not yet recruiting

  • Klinik Weinheim

    Weinheim, 69469

    Lelia Bauer

    Not yet recruiting

  • Helios HSK Wiesbaden

    Wiesbaden, 65199

    0049611432377

    Michael Eichbaum

    Not yet recruiting

  • Marien Hospital Witten

    Witten, 58452

    004923021733290

    Monika Graeser

    Not yet recruiting

  • HELIOS Klinikum Wuppertal

    Wuppertal, 42283

    0492028961411

    Vesna Bjelic-Radisic

    Not yet recruiting

Other trials in Germany

Italy6 sites, 6 recruiting

  • Ente Ospedaliero Ospedali Galliera

    Genova, 16128

    +39.010563.4580

    Matteo Lambertini

    Recruiting

  • Humanitas

    Milan, 20089

    0039028224 4089

    carmen criscitiello

    Not yet recruiting

  • Istituto Europeo di Oncologia IRCCS

    Milan, 20141

    00390257489215

    Giuseppe Curigliano

    Not yet recruiting

  • Humanitas Istituto Clinico Catanese

    Misterbianco, 95045

    Maria Vita Sanò

    Recruiting

  • Nuovo Ospedale di Prato-S.Stefano

    Prato, 59100

    +39 0574 802531

    Laura Biganzoli

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168

    00390630157337

    Alessandra Fabi

    Not yet recruiting

Other trials in Italy

Taiwan6 sites, 6 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

    8867-3121101 ext.6235

    Ming-Feng Hou

    Not yet recruiting

  • China Medical University Hospital

    Taichung, 404332

    Hwei-Chung Wang

    Not yet recruiting

  • Taichung Veterans General Hospital

    Taichung, 407

    886-42359-2525-5031

    Chih-Chiang Hung

    Not yet recruiting

  • National Cheng Kung University Hospital

    Tainan, 704

    Kuo-Ting Lee

    Not yet recruiting

  • Mackay Memorial Hospital

    Taipei, 10449

    886975835311

    Yuan-Ching Chang

    Not yet recruiting

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

    Shih-Che Shen

    Not yet recruiting

Other trials in Taiwan

France5 sites, 5 recruiting

  • CHRU de Brest

    Brest, 29609

    Laura Deiana

    Recruiting

  • Centre de Cancérologie du Grand Montpellier

    Montpellier, 34070

    467926155

    Cristian Villanueva

    Recruiting

  • Hôpital Privé Des Côtes d'Armor

    Plérin, 22190

    Jerome Martin-Babau

    Recruiting

  • Institut Curie - site Saint-Cloud

    Saint-Cloud, 92210

    Diana Bello Roufai

    Recruiting

  • Gustave Roussy

    Villejuif, 94800

    Barbara Pistilli

    Not yet recruiting

Other trials in France

Belgium3 sites, 3 recruiting

  • Cliniques universitaires Saint-Luc

    Brussels, 1200

    3227645435

    Francois Duhoux

    Not yet recruiting

  • Antwerp University Hospital

    Edegem, 2650

    Sevilay Altintas

    Not yet recruiting

  • UZ Leuven

    Leuven, 3000

    003216345129

    Patrick Neven

    Not yet recruiting

Other trials in Belgium

Ireland3 sites, 3 recruiting

  • St. Vincent's University Hospital

    Dublin, D04 T6F4

    012214000

    Janice Walshe

    Not yet recruiting

  • St. James's Hospital

    Dublin, D08 E9P6

    014103000

    Ciara O Hanlon Brown

    Not yet recruiting

  • Galway University Hospital

    Galway, H91 YR71

    Maccon Keane

    Not yet recruiting

Other trials in Ireland

About this study

Official title: preEMBER: A Phase 2, Open-label Study Evaluating Imlunestrant in Premenopausal Women With Estrogen Receptor-Positive, HER2-Negative Breast Cancer

This study will include two groups of patients: Cohort 1 and Cohort 2.

Cohort 1: will help researchers learn how a medicine called imlunestrant (LY3484356) affects a specific type of breast cancer. Some patients will take both imlunestrant and another treatment to suppress their ovarian function. Some will take it without ovarian suppression. Researchers will compare the effects in breast cancer cells to those of another medicine called tamoxifen. All patients in this group will be premenopausal women who have a type of early breast cancer called estrogen receptor-positive, HER2-negative. The treatment in this group will last for up to 29 days.

Cohort 2: will help researchers understand how imlunestrant affects the ovaries when it is taken without ovarian suppression. Researchers will compare the effects to those of another medicine called tamoxifen. This group will also include premenopausal women with the same type of breast cancer. The treatment in this group will last for up to 6 months.

Being tested
Imlunestrant, Goserelin, Tamoxifen 20 mg
Medical subject headings
Breast Neoplasms

What participants receive

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

  • ImlunestrantDrug

    Also called LY3484356

    Given orally

  • GoserelinDrug

    Given SC

  • Tamoxifen 20 mgDrug

    Given orally

Study groups in NCT07287098
Study groupRoleWhat they receive
Cohort 1 Arm AExperimentalImlunestrant will be given orally
Receives: Drug: Imlunestrant
Cohort 1 Arm B - Imlunestrant + GoserelinExperimentalImlunestrant will be given orally and goserelin will be given subcutaneously (SC)
Receives: Drug: Imlunestrant; Drug: Goserelin
Cohort 1 Arm C - TamoxifenActive comparatorTamoxifen will be given orally
Receives: Drug: Tamoxifen 20 mg
Cohort 2 Arm A - ImlunestrantExperimentalImlunestrant will be given orally
Receives: Drug: Imlunestrant
Cohort 2 Arm B - TamoxifenActive comparatorTamoxifen will be given orally
Receives: Drug: Tamoxifen 20 mg

What is being measured

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

  1. Change from Baseline in Antigen Kiel (Ki-67) Expression

    Measured: Baseline, Day 29

  2. Rate of Symptomatic Ovarian Cysts

    Measured: Up to Day 180

Secondary outcomes (3)

  1. Change from Baseline in Estrogen Receptor (ER) Expression

    Measured: Baseline, Day 29

  2. Change from Baseline in Progesterone Receptor (PR) Expression

    Measured: Baseline, Day 29

  3. Rate of Complex Ovarian Cysts

    Measured: Up to Day 180

Timeline

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

  1. First posted17 Dec 2025
  2. Study start13 May 2026
  3. Primary completionJan 2029 (estimated)
  4. Study completionDec 2029 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07287098
Sponsor's protocol ID
27511
Other IDs
2025-523258-15-00, J2J-MC-JZLL, 2025
Acronym
preEMBER
Status last verified
Nov 2026
First submitted
11 Dec 2025
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Imlunestrant, Goserelin and Tamoxifen 20 mg in people with Breast Neoplasms, run by Eli Lilly and Company at 90 sites in 7 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 22 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States, Germany, Italy, Taiwan, France and 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Antigen Kiel (Ki-67) Expression (time frame: Baseline, Day 29). The study lists 2 primary outcomes in all. 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 NCT07287098.

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 4 Nov 2026.

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