A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer
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About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony histologicznie nowotwór piersi (stadium I-III), dodatni na receptor estrogenowy (ER+), ujemny na receptor wzrostu HER2, z wskaźnikiem Ki-67 co najmniej 10%
- •Chęć i możliwość pobrania próbek guza przed i podczas leczenia
- •Ogólny stan zdrowia oceniany na 0 lub 1 w skali ECOG
- •Zdolność połykania kapsułek lub tabletek
- •Kobiety przed menopauzą
- •Stosowanie skutecznej, niehormональnej antykoncepcji podczas badania i przez okres określony w protokole
- •Prawidłowe funkcjonowanie organów wewnętrznych
✗ Disqualifies
- •Nowotwór piersi z przerzutami do obu piersi, z pierwotnym ogniskiem nieznanym lub nowotwór zapalny piersi
- •Wcześniejsze usunięcie obu jajników lub ablacja jajników
- •Poważna choroba towarzysząca
- •Poważna operacja w ciągu 28 dni przed rozpoczęciem badania
- •Historia innego nowotworu (z wyjątkiem niemelanomowego raka skóry), chyba że całkowita remisja bez leczenia przez co najmniej 1 rok
- •Wcześniejsze leczenie nowotworu piersi lub terapia hormonalna wymierzona przeciwko estrogenowi
- •Wcześniejsze leczenie lekami GnRH w ciągu 12 miesięcy przed rozpoczęciem badania
- •Bieżące przyjmowanie egzogennych hormonów reprodukcyjnych
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- June 26, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (71)
University of Alabama at Birmingham
Birmingham, United States
Ironwood Cancer & Research Centers
Chandler, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, United States
UCLA Hematology/Oncology - Parkside
Santa Monica, United States
Banner MD Anderson Cancer Center at North Colorado Medical Center
Greeley, United States
Banner MD Anderson Cancer Center at McKee Medical Center
Loveland, United States
AdventHealth Altamonte Springs
Altamonte Springs, United States
Winship Cancer Institute
Atlanta, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, United States
Massachusetts General Hospital
Boston, United States
Dana-Farber Cancer Institute
Boston, United States
Washington University School of Medicine
St Louis, United States
New York Oncology Hematology, P.C.
Albany, United States
Wilmot Cancer Institute
Rochester, United States
New York Cancer and Blood Specialists
Shirley, United States
University of North Carolina Medical Center
Chapel Hill, United States
Cleveland Clinic
Cleveland, United States
Providence Portland Medical Center
Portland, United States
Tennessee Oncology
Nashville, United States
University of Texas MD Anderson Cancer Center
Houston, United States
Houston Methodist Hospital
Houston, United States
Oncology Consultants P.A.
Houston, United States
Baylor Scott & White Medical Center - Round Rock
Round Rock, United States
Huntsman Cancer Institute
Salt Lake City, United States
The University of Vermont Medical Center Inc.
Burlington, United States
University of Virginia Health System
Charlottesville, United States
Inova Schar Cancer Institute
Fairfax, 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
Onkologische Schwerpunktpraxis Bielefeld
Bielefeld, Germany
Marienhospital Bottrop
Bottrop, Germany
Studien GbR Braunschweig
Braunschweig, Germany
Onkologisch - Hämatologische Schwerpunktpraxis
Bremen, Germany
St. Elisabeth - Krankenhaus Köln - Hohenlind
Cologne, Germany
Medizinische Universität Lausitz- Carl Thiem
Cottbus, Germany
Universitaetsklinikum Erlangen
Erlangen, Germany
Universitaetsklinikum Essen
Essen, Germany
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung
Essen, Germany
Agaplesion Markus Krankenhaus
Frankfurt, Germany
Mammazentrum HH - Krankenhaus Jerusalem
Hamburg, Germany
Frauenärzte am Bahnhofsplatz
Hildesheim, Germany
Evangelisches Krankenhaus Bethesda Mönchengladbach
Mönchengladbach, Germany
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
München, Germany
Rotkreuzklinikum München gemeinnützige GmbH
München, Germany
MVZ für Hämatologie und Onkologie Ravensburg GmbH - Studienzentrum
Ravensburg, Germany
Klinikum Mutterhaus der Borromäerinnen
Trier, Germany
Hämatologisch-Onkologische Schwerpunktpraxis
Troisdorf, Germany
Universitaetsklinikum Tuebingen
Tübingen, Germany
Universitaetsklinikum Ulm
Ulm, 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
Trial contact
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Physicians interested in becoming principal investigators please contact
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.