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NCT07287098PHASE2Recruiting

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

Eli Lilly and Company

Start Date

5/13/2026

Completion Date

12/1/2029

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. 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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 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. * 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. Exclusion Criteria: 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. * 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.

Interventions

DRUG

Imlunestrant

DRUG

Goserelin

DRUG

Tamoxifen 20 mg

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Conditions

Breast Neoplasms

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35205

United States

Ironwood Cancer & Research Centers

Chandler, Arizona 85224

United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

UCLA Hematology/Oncology - Parkside

Santa Monica, California 90404

United States

Banner MD Anderson Cancer Center at North Colorado Medical Center

Greeley, Colorado 80631

United States

Banner MD Anderson Cancer Center at McKee Medical Center

Loveland, Colorado 80538

United States

AdventHealth Altamonte Springs

Altamonte Springs, Florida 32701

United States

Winship Cancer Institute

Atlanta, Georgia 30322

United States

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana 46202

United States

University of Kentucky Chandler Medical Center

Lexington, Kentucky 40536

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

New York Oncology Hematology, P.C.

Albany, New York 12206

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Wilmot Cancer Institute

Rochester, New York 14642

United States

New York Cancer and Blood Specialists

Shirley, New York 11967

United States

University of North Carolina Medical Center

Chapel Hill, North Carolina 27514

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Providence Portland Medical Center

Portland, Oregon 97213

United States

Tennessee Oncology

Nashville, Tennessee 37203

United States

University of Texas MD Anderson Cancer Center

Houston, Texas 77030-4009

United States

Houston Methodist Hospital

Houston, Texas 77030

United States

Oncology Consultants P.A.

Houston, Texas 77030

United States

Baylor Scott & White Medical Center - Round Rock

Round Rock, Texas 78665

United States

Huntsman Cancer Institute

Salt Lake City, Utah 84112

United States

The University of Vermont Medical Center Inc.

Burlington, Vermont 05401

United States

University of Virginia Health System

Charlottesville, Virginia 22903

United States

Inova Schar Cancer Institute

Fairfax, Virginia 22031

United States

Cliniques universitaires Saint-Luc

Brussels, 1200

Belgium

Antwerp University Hospital

Edegem, 2650

Belgium

UZ Leuven

Leuven, 3000

Belgium

CHRU de Brest

Brest, 29609

France

Centre de Cancérologie du Grand Montpellier

Montpellier, 34070

France

Hôpital Privé Des Côtes d'Armor

Plérin, 22190

France

Institut Curie - site Saint-Cloud

Saint-Cloud, 92210

France

Gustave Roussy

Villejuif, 94800

France

Onkologische Schwerpunktpraxis Bielefeld

Bielefeld, 33604

Germany

Augusta-Kranken-Anstalt

Bochum, 44791

Germany

Marienhospital Bottrop

Bottrop, 46236

Germany

Studien GbR Braunschweig

Braunschweig, 38100

Germany

Onkologisch - Hämatologische Schwerpunktpraxis

Bremen, 28209

Germany

St. Elisabeth - Krankenhaus Köln - Hohenlind

Cologne, 50935

Germany

Medizinische Universität Lausitz- Carl Thiem

Cottbus, 03048

Germany

Universitaetsklinikum Erlangen

Erlangen, 91054

Germany

Universitaetsklinikum Essen

Essen, 45122

Germany

Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung

Essen, 45136

Germany

Agaplesion Markus Krankenhaus

Frankfurt, 60431

Germany

Mammazentrum HH - Krankenhaus Jerusalem

Hamburg, 20357

Germany

Frauenärzte am Bahnhofsplatz

Hildesheim, 31134

Germany

Evangelisches Krankenhaus Bethesda Mönchengladbach

Mönchengladbach, 41061

Germany

Klinikum der Ludwig-Maximilians-Universitaet Muenchen

München, 80336

Germany

Rotkreuzklinikum München gemeinnützige GmbH

München, 80637

Germany

Ruppiner Kliniken

Neuruppin, 16816

Germany

Klinikum Ernst von Bergmann

Potsdam, 14467

Germany

MVZ für Hämatologie und Onkologie Ravensburg GmbH - Studienzentrum

Ravensburg, 88212

Germany

Klinikum Mutterhaus der Borromäerinnen

Trier, 54290

Germany

Hämatologisch-Onkologische Schwerpunktpraxis

Troisdorf, 53840

Germany

Universitaetsklinikum Tuebingen

Tübingen, 72076

Germany

Universitaetsklinikum Ulm

Ulm, 89075

Germany

Klinik Weinheim

Weinheim, 69469

Germany

Marien Hospital Witten

Witten, 58452

Germany

HELIOS Klinikum Wuppertal

Wuppertal, 42283

Germany

St. Vincent's University Hospital

Dublin, D04 T6F4

Ireland

St. James's Hospital

Dublin, D08 E9P6

Ireland

Galway University Hospital

Galway, H91 YR71

Ireland

Ente Ospedaliero Ospedali Galliera

Genova, 16128

Italy

Humanitas

Milan, 20089

Italy

Istituto Europeo di Oncologia IRCCS

Milan, 20141

Italy

Humanitas Istituto Clinico Catanese

Misterbianco, 95045

Italy

Nuovo Ospedale di Prato-S.Stefano

Prato, 59100

Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, 00168

Italy

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807

Taiwan

China Medical University Hospital

Taichung, 404332

Taiwan

Taichung Veterans General Hospital

Taichung, 407

Taiwan

National Cheng Kung University Hospital

Tainan, 704

Taiwan

Mackay Memorial Hospital

Taipei, 10449

Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, 333

Taiwan