A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer
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
Interventions
Imlunestrant
Goserelin
Tamoxifen 20 mg
Conditions
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