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RECRUITING

NCT07287098

PHASE2

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2026-05-13

Completion Date

2029-12

Last Updated

2026-08-21

Healthy Volunteers

Conditions

Breast Neoplasms

Interventions

DRUG

Imlunestrant

Given orally

DRUG

Goserelin

Given SC

DRUG

Tamoxifen 20 mg

Given orally

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.

Locations (89)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Ironwood Cancer & Research Centers

Chandler, Arizona, United States

Mayo Clinic in Arizona - Phoenix

Phoenix, Arizona, United States

City of Hope

Duarte, California, United States

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

UCLA Hematology/Oncology - Parkside

Santa Monica, California, United States

Banner MD Anderson Cancer Center at North Colorado Medical Center

Greeley, Colorado, United States

Banner MD Anderson Cancer Center at McKee Medical Center

Loveland, Colorado, United States

AdventHealth Altamonte Springs

Altamonte Springs, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Winship Cancer Institute

Atlanta, Georgia, United States

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

University of Kentucky Chandler Medical Center

Lexington, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

New York Oncology Hematology, P.C.

Albany, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Wilmot Cancer Institute

Rochester, New York, United States

New York Cancer and Blood Specialists

Shirley, New York, United States

University of North Carolina Medical Center

Chapel Hill, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Providence Portland Medical Center

Portland, Oregon, United States

Providence St. Vincent Medical Center

Portland, Oregon, United States

Tennessee Oncology

Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Oncology Consultants P.A.

Houston, Texas, United States

Baylor Scott & White Medical Center - Round Rock

Round Rock, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

The University of Vermont Medical Center Inc.

Burlington, Vermont, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Cliniques universitaires Saint-Luc

Brussels, Belgium

Antwerp University Hospital

Edegem, Belgium

UZ Leuven

Leuven, Belgium

CHRU de Brest

Brest, France

Centre de Cancérologie du Grand Montpellier

Montpellier, France

Hôpital Privé Des Côtes d'Armor

Plérin, France

Institut Curie - site Saint-Cloud

Saint-Cloud, France

Gustave Roussy

Villejuif, France

Evangelisches Krankenhaus Bergisch Gladbach

Bergisch Gladbach, Germany

Praxis am Volkspark

Berlin, Germany

Onkologische Schwerpunktpraxis Bielefeld

Bielefeld, Germany

Augusta-Kranken-Anstalt

Bochum, Germany

Gynaekologisches Zentrum Bonn

Bonn, Germany

Marienhospital Bottrop

Bottrop, Germany

Onkologisch - Hämatologische Schwerpunktpraxis

Bremen, Germany

Krankenhaus Köln-Holweide

Cologne, Germany

Medizinische Universität Lausitz- Carl Thiem

Cottbus, Germany

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

Dresden, Germany

Universitaetsklinikum Erlangen

Erlangen, Germany

Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung

Essen, Germany

Universitaetsklinikum Essen

Essen, Germany

Agaplesion Markus Krankenhaus

Frankfurt, Germany

Mammazentrum HH - Krankenhaus Jerusalem

Hamburg, Germany

Praxisklinik Harburg

Hamburg, Germany

Frauenärzte am Bahnhofsplatz

Hildesheim, Germany

Universitaetsklinikum Schleswig-Holstein Campus Kiel

Kiel, Germany

Evangelisches Krankenhaus Bethesda Mönchengladbach

Mönchengladbach, Germany

Klinikum der Ludwig-Maximilians-Universitaet Muenchen

München, Germany

Rotkreuzklinikum München gemeinnützige GmbH

München, Germany

Ruppiner Kliniken

Neuruppin, Germany

Klinikum Ernst von Bergmann

Potsdam, Germany

MVZ für Hämatologie und Onkologie Ravensburg GmbH - Studienzentrum

Ravensburg, Germany

Klinikum Mutterhaus der Borromäerinnen

Trier, Germany

Universitaetsklinikum Tuebingen

Tübingen, Germany

Universitaetsklinikum Ulm

Ulm, Germany

Klinik Weinheim

Weinheim, Germany

Helios HSK Wiesbaden

Wiesbaden, Germany

Marien Hospital Witten

Witten, Germany

HELIOS Klinikum Wuppertal

Wuppertal, Germany

St. Vincent's University Hospital

Dublin, Ireland

St. James's Hospital

Dublin, Ireland

Galway University Hospital

Galway, Ireland

Ente Ospedaliero Ospedali Galliera

Genova, Italy

Humanitas

Milan, Italy

Istituto Europeo di Oncologia IRCCS

Milan, Italy

Humanitas Istituto Clinico Catanese

Misterbianco, Italy

Nuovo Ospedale di Prato-S.Stefano

Prato, Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, Italy

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Mackay Memorial Hospital

Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, Taiwan

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (89)