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NOT YET 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

Completion Date

2029-12

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

DRUG

Imlunestrant

Given orally

DRUG

Goserelin

Given SC

DRUG

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