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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
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
Completion Date
2029-12
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Imlunestrant
Given orally
Goserelin
Given SC
Tamoxifen 20 mg
Given orally
Locations (23)
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Tennessee Oncology
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Oncology Consultants P.A.
Houston, Texas, 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
Universitaetsklinikum Erlangen
Erlangen, Germany
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung
Essen, Germany
Frauenärzte am Bahnhofsplatz
Hildesheim, Germany
Klinikum Mutterhaus der Borromäerinnen
Trier, Germany
Ente Ospedaliero Ospedali Galliera
Genova, Italy
Humanitas
Milan, Italy
Humanitas Istituto Clinico Catanese
Misterbianco, Italy
Nuovo Ospedale di Prato-S.Stefano
Prato, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Italy