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Clinical trialNCT07287098RecruitingPhase 2Interventional

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

SponsorEli Lilly and CompanyEnrollment600Breast Neoplasms
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    Study Director

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

89 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Belgium
  • Cliniques Universitaires Saint-Luc

    Brussels, Belgium

    Francois Duhoux
    Not, yet, recruiting
  • Antwerp University Hospital

    Edegem, Belgium

    Sevilay Altintas
    Not, yet, recruiting
  • Uz Leuven

    Leuven, Belgium

    Patrick Neven
    Not, yet, recruiting
France
  • Chru de Brest

    Brest, France

    Laura Deiana
    Not, yet, recruiting
  • Centre de Cancérologie Du Grand Montpellier

    Montpellier, France

    Cristian Villanueva
    Not, yet, recruiting
  • Hôpital Privé Des Côtes D'Armor

    Plérin, France

    Jerome Martin-Babau
    Not, yet, recruiting
  • Institut Curie - Site Saint-Cloud

    Saint-Cloud, France

    Diana Bello Roufai
    Not, yet, recruiting
  • Gustave Roussy

    Villejuif, France

    Barbara Pistilli
    Not, yet, recruiting
Germany
  • Evangelisches Krankenhaus Bergisch Gladbach

    Bergisch Gladbach, Germany

    Rudlowski Rudlowski
    Not, yet, recruiting
  • Praxis Am Volkspark

    Berlin, Germany

    Jan-Piet Habbel
    Not, yet, recruiting
  • Onkologische Schwerpunktpraxis Bielefeld

    Bielefeld, Germany

    Siemke Steinke
    Not, yet, recruiting
  • Augusta-Kranken-Anstalt

    Bochum, Germany

    Matthias Losch
    Not, yet, recruiting
  • Gynaekologisches Zentrum Bonn

    Bonn, Germany

    Christian Kurbacher
    Not, yet, recruiting
  • Marienhospital Bottrop

    Bottrop, Germany

    Hans-Christian Kolberg
    Not, yet, recruiting
  • Onkologisch - Hämatologische Schwerpunktpraxis

    Bremen, Germany

    Ralf Meyer
    Not, yet, recruiting
  • Krankenhaus Köln-Holweide

    Cologne, Germany

    Ilka Bernhöft
    Not, yet, recruiting
  • Medizinische Universität Lausitz- Carl Thiem

    Cottbus, Germany

    Nikola Bangemann
    Not, yet, recruiting
  • Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf

    Dresden, Germany

    Thomas Illmer
    Not, yet, recruiting
  • Universitaetsklinikum Erlangen

    Erlangen, Germany

    Peter Fasching
    Not, yet, recruiting
  • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung

    Essen, Germany

    Sherko Kümmel
    Not, yet, recruiting
  • Universitaetsklinikum Essen

    Essen, Germany

    Ann-Kathrin Bittner
    Not, yet, recruiting
  • Agaplesion Markus Krankenhaus

    Frankfurt, Germany

    Marc Thill
    Not, yet, recruiting
  • Mammazentrum Hh - Krankenhaus Jerusalem

    Hamburg, Germany

    Anne-Sophie Adam
    Not, yet, recruiting
  • Praxisklinik Harburg

    Hamburg, Germany

    Christoph Grossmann
    Not, yet, recruiting
  • Frauenärzte Am Bahnhofsplatz

    Hildesheim, Germany

    Christoph Uleer
    Recruiting
  • Universitaetsklinikum Schleswig-Holstein Campus Kiel

    Kiel, Germany

    Marion van Mackelenbergh
    Not, yet, recruiting
  • Evangelisches Krankenhaus Bethesda Mönchengladbach

    Mönchengladbach, Germany

    Katja Krauss
    Not, yet, recruiting
  • Klinikum Der Ludwig-Maximilians-Universitaet Muenchen

    München, Germany

    Nadia Harbeck
    Not, yet, recruiting
  • Rotkreuzklinikum München Gemeinnützige Gmbh

    München, Germany

    Michael Braun
    Not, yet, recruiting
  • Ruppiner Kliniken

    Neuruppin, Germany

    Verena Kiver
    Not, yet, recruiting
  • Klinikum Ernst Von Bergmann

    Potsdam, Germany

    Dorothea Fischer
    Not, yet, recruiting
  • Mvz Für Hämatologie Und Onkologie Ravensburg Gmbh - Studienzentrum

    Ravensburg, Germany

    Thomas Decker
    Not, yet, recruiting
  • Klinikum Mutterhaus Der Borromäerinnen

    Trier, Germany

    Sebastian Jud
    Not, yet, recruiting
  • Universitaetsklinikum Tuebingen

    Tübingen, Germany

    Tobias Engler
    Not, yet, recruiting
  • Universitaetsklinikum Ulm

    Ulm, Germany

    Henning Schäffler
    Not, yet, recruiting
  • Klinik Weinheim

    Weinheim, Germany

    Lelia Bauer
    Not, yet, recruiting
  • Helios Hsk Wiesbaden

    Wiesbaden, Germany

    Michael Eichbaum
    Not, yet, recruiting
  • Marien Hospital Witten

    Witten, Germany

    Monika Graeser
    Not, yet, recruiting
  • Helios Klinikum Wuppertal

    Wuppertal, Germany

    Vesna Bjelic-Radisic
    Not, yet, recruiting
Ireland
  • St. James'S Hospital

    Dublin, Ireland

    Ciara O Hanlon Brown
    Not, yet, recruiting
49 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
13 May 2026
Primary completion
31 Jan 2029
Completion
31 Dec 2029
Last update posted
21 Aug 2026
Registered enrollment
600
Registry id
NCT07287098

Cross-registrations

EU-CTR / CTIS (EudraCT)2025-523258-15-00

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.