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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

NCT07287098 · Eli Lilly and Company
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Official title
preEMBER: A Phase 2, Open-label Study Evaluating Imlunestrant in Premenopausal Women With Estrogen Receptor-Positive, HER2-Negative Breast Cancer
About this study
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
Inclusion Criteria: Cohort 1: * Have histologically confirmed Stage I to III Estrogen Receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) invasive breast carcinoma with Ki-67 at least 10% * Be willing and able to provide pre- and on-treatment tumor samples. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Be able to swallow capsules or tablets. * Be premenopausal women. * If of childbearing potential must use 1 highly effective method of non-hormonal contraception while receiving study treatment and for the duration specified in protocol. * Have adequate organ function. Cohort 2: * Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis * Have undergone definitive loco-regional therapy. * Have received at least 4.5 years of any adjuvant endocrine therapy (ET), or at least 2 years of adjuvant ET with no additional ovarian suppression planned. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Be able to swallow capsules or tablets. * Be premenopausal women * If of childbearing potential must use 1 highly effective method of non-hormonal contraception while receiving study treatment and for the duration specified in protocol. * Have adequate organ function. Exclusion Criteria: Cohort 1: * Have bilateral invasive metastatic, occult primary, or inflammatory breast cancer. * Have had prior bilateral oophorectomy or ovarian ablation. * Have a serious medical condition * Had major surgery within 28 days prior to randomization. * Have a history of other cancer (except non melanoma skin cancer, Stage I uterine cancer, or carcinoma in situ of the cervix or other in situ cancer), unless in complete remission with no therapy for a minimum of 1 year. * Plan to receive concurrent neoadjuvant therapy with any other non-protocol anticancer therapy. * Have had any prior therapy for an invasive or non-invasive breast cancer. * Have had prior radiotherapy to the ipsilateral chest wall for any malignancy. * Have received prior anti-estrogen therapy, including for osteoporosis or prevention of breast cancer. * Have had prior treatment with any Gonadotropin-releasing hormone (GnRH) agonist within 12 months prior to randomization. * Receiving current exogenous reproductive hormone therapy Cohort 2: * Have ovarian cyst(s) greater than (\>) 1 centimeter (cm) at screening. * Have metastatic occult primary, or inflammatory breast cancer. * Have had prior bilateral oophorectomy or ovarian ablation. * Have a serious medical condition * Had major surgery within 28 days prior to randomization. * Have a history of other cancer (except non melanoma skin cancer or carcinoma in situ of the cervix or other in situ cancer), unless in complete remission with no therapy for a minimum of 1 year. * Completed or discontinued prior adjuvant ET \>6 months prior to screening. * Have received prior therapy with any selective estrogen receptor degrader (SERD). * Receiving current exogenous reproductive hormone therapy.
Study design
Enrollment target: 600 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-05-13
Estimated completion: 2029-12
Last updated: 2026-07-17
Interventions
Drug: ImlunestrantDrug: GoserelinDrug: Tamoxifen 20 mg
Primary outcomes
  • Change from Baseline in Antigen Kiel (Ki-67) Expression (Baseline, Day 29)
  • Rate of Symptomatic Ovarian Cysts (Up to Day 180)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 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) · study_director, Eli Lilly and Company
All locations (78)
University of Alabama at BirminghamNot Yet Recruiting
Birmingham, Alabama, United States
Ironwood Cancer & Research CentersSuspended
Chandler, Arizona, United States
USC/Norris Comprehensive Cancer CenterNot Yet Recruiting
Los Angeles, California, United States
UCLA Hematology/Oncology - ParksideNot Yet Recruiting
Santa Monica, California, United States
Banner MD Anderson Cancer Center at North Colorado Medical CenterNot Yet Recruiting
Greeley, Colorado, United States
Banner MD Anderson Cancer Center at McKee Medical CenterNot Yet Recruiting
Loveland, Colorado, United States
AdventHealth Altamonte SpringsNot Yet Recruiting
Altamonte Springs, Florida, United States
Winship Cancer InstituteNot Yet Recruiting
Atlanta, Georgia, United States
Indiana University Melvin and Bren Simon Cancer CenterRecruiting
Indianapolis, Indiana, United States
University of Kentucky Chandler Medical CenterNot Yet Recruiting
Lexington, Kentucky, United States
Massachusetts General HospitalNot Yet Recruiting
Boston, Massachusetts, United States
Dana-Farber Cancer InstituteNot Yet Recruiting
Boston, Massachusetts, United States
Washington University School of MedicineNot Yet Recruiting
St Louis, Missouri, United States
New York Oncology Hematology, P.C.Not Yet Recruiting
Albany, New York, United States
Memorial Sloan Kettering Cancer CenterNot Yet Recruiting
New York, New York, United States
Wilmot Cancer InstituteNot Yet Recruiting
Rochester, New York, United States
New York Cancer and Blood SpecialistsNot Yet Recruiting
Shirley, New York, United States
University of North Carolina Medical CenterNot Yet Recruiting
Chapel Hill, North Carolina, United States
Cleveland ClinicNot Yet Recruiting
Cleveland, Ohio, United States
Providence Portland Medical CenterNot Yet Recruiting
Portland, Oregon, United States
Tennessee OncologyNot Yet Recruiting
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Houston Methodist HospitalNot Yet Recruiting
Houston, Texas, United States
Oncology Consultants P.A.Recruiting
Houston, Texas, United States
Baylor Scott & White Medical Center - Round RockNot Yet Recruiting
Round Rock, Texas, United States
Huntsman Cancer InstituteNot Yet Recruiting
Salt Lake City, Utah, United States
The University of Vermont Medical Center Inc.Not Yet Recruiting
Burlington, Vermont, United States
University of Virginia Health SystemNot Yet Recruiting
Charlottesville, Virginia, United States
Inova Schar Cancer InstituteNot Yet Recruiting
Fairfax, Virginia, United States
Cliniques universitaires Saint-LucNot Yet Recruiting
Brussels, Belgium
Antwerp University HospitalNot Yet Recruiting
Edegem, Belgium
UZ LeuvenNot Yet Recruiting
Leuven, Belgium
CHRU de BrestNot Yet Recruiting
Brest, France
Centre de Cancérologie du Grand MontpellierNot Yet Recruiting
Montpellier, France
Hôpital Privé Des Côtes d'ArmorNot Yet Recruiting
Plérin, France
Institut Curie - site Saint-CloudNot Yet Recruiting
Saint-Cloud, France
Gustave RoussyNot Yet Recruiting
Villejuif, France
Onkologische Schwerpunktpraxis BielefeldNot Yet Recruiting
Bielefeld, Germany
Augusta-Kranken-AnstaltNot Yet Recruiting
Bochum, Germany
Marienhospital BottropNot Yet Recruiting
Bottrop, Germany
Studien GbR BraunschweigNot Yet Recruiting
Braunschweig, Germany
Onkologisch - Hämatologische SchwerpunktpraxisNot Yet Recruiting
Bremen, Germany
St. Elisabeth - Krankenhaus Köln - HohenlindNot Yet Recruiting
Cologne, Germany
Medizinische Universität Lausitz- Carl ThiemNot Yet Recruiting
Cottbus, Germany
Universitaetsklinikum ErlangenNot Yet Recruiting
Erlangen, Germany
Universitaetsklinikum EssenNot Yet Recruiting
Essen, Germany
Kliniken Essen-Mitte, Evangelische Huyssens-StiftungNot Yet Recruiting
Essen, Germany
Agaplesion Markus KrankenhausNot Yet Recruiting
Frankfurt, Germany
Mammazentrum HH - Krankenhaus JerusalemNot Yet Recruiting
Hamburg, Germany
Frauenärzte am BahnhofsplatzNot Yet Recruiting
Hildesheim, Germany
Evangelisches Krankenhaus Bethesda MönchengladbachNot Yet Recruiting
Mönchengladbach, Germany
Klinikum der Ludwig-Maximilians-Universitaet MuenchenNot Yet Recruiting
München, Germany
Rotkreuzklinikum München gemeinnützige GmbHNot Yet Recruiting
München, Germany
Ruppiner KlinikenNot Yet Recruiting
Neuruppin, Germany
Klinikum Ernst von BergmannNot Yet Recruiting
Potsdam, Germany
MVZ für Hämatologie und Onkologie Ravensburg GmbH - StudienzentrumNot Yet Recruiting
Ravensburg, Germany
Klinikum Mutterhaus der BorromäerinnenNot Yet Recruiting
Trier, Germany
Hämatologisch-Onkologische SchwerpunktpraxisNot Yet Recruiting
Troisdorf, Germany
Universitaetsklinikum TuebingenNot Yet Recruiting
Tübingen, Germany
Universitaetsklinikum UlmNot Yet Recruiting
Ulm, Germany
Klinik WeinheimNot Yet Recruiting
Weinheim, Germany
Marien Hospital WittenNot Yet Recruiting
Witten, Germany
HELIOS Klinikum WuppertalNot Yet Recruiting
Wuppertal, Germany
St. Vincent's University HospitalNot Yet Recruiting
Dublin, Ireland
St. James's HospitalNot Yet Recruiting
Dublin, Ireland
Galway University HospitalNot Yet Recruiting
Galway, Ireland
Ente Ospedaliero Ospedali GallieraNot Yet Recruiting
Genova, Italy
HumanitasNot Yet Recruiting
Milan, Italy
Istituto Europeo di Oncologia IRCCSNot Yet Recruiting
Milan, Italy
Humanitas Istituto Clinico CataneseNot Yet Recruiting
Misterbianco, Italy
Nuovo Ospedale di Prato-S.StefanoNot Yet Recruiting
Prato, Italy
Fondazione Policlinico Universitario Agostino GemelliNot Yet Recruiting
Roma, Italy
Kaohsiung Medical University Chung-Ho Memorial HospitalNot Yet Recruiting
Kaohsiung City, Taiwan
China Medical University HospitalNot Yet Recruiting
Taichung, Taiwan
Taichung Veterans General HospitalNot Yet Recruiting
Taichung, Taiwan
National Cheng Kung University HospitalNot Yet Recruiting
Tainan, Taiwan
Mackay Memorial HospitalNot Yet Recruiting
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou BranchNot Yet Recruiting
Taoyuan, Taiwan
A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer · TrialPath