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Not yet recruiting Phase 2 NCT07287098

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

Phase 2 – studying effectiveness and dosage
Conditions: Breast Neoplasms

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
Imlunestrant
DRUG
Goserelin
DRUG
Tamoxifen 20 mg
DRUG
Locations 42
Belgium (3)
Cliniques universitaires Saint-Luc
Brussels
Antwerp University Hospital
Edegem
UZ Leuven
Leuven
France (4)
CHRU de Brest
Brest
Centre de Cancérologie du Grand Montpellier
Montpellier
Hôpital Privé Des Côtes d'Armor
Plérin
Institut Curie - site Saint-Cloud
Saint-Cloud
Germany (14)
Onkologische Schwerpunktpraxis Bielefeld
Bielefeld
Medizinische Universität Lausitz- Carl Thiem
Cottbus
Universitaetsklinikum Erlangen
Erlangen
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung
Essen
Agaplesion Markus Krankenhaus
Frankfurt
Frauenärzte am Bahnhofsplatz
Hildesheim
Evangelisches Krankenhaus Bethesda Mönchengladbach
Mönchengladbach
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
München
Rotkreuzklinikum München gemeinnützige GmbH
München
Klinikum Mutterhaus der Borromäerinnen
Trier
Hämatologisch-Onkologische Schwerpunktpraxis
Troisdorf
Universitaetsklinikum Tuebingen
Tübingen
Marien Hospital Witten
Witten
HELIOS Klinikum Wuppertal
Wuppertal
Italy (5)
Ente Ospedaliero Ospedali Galliera
Genova
Humanitas
Milan
Humanitas Istituto Clinico Catanese
Misterbianco
Nuovo Ospedale di Prato-S.Stefano
Prato
Fondazione Policlinico Universitario Agostino Gemelli
Roma
Taiwan (6)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
China Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
National Cheng Kung University Hospital
Tainan
Mackay Memorial Hospital
Taipei
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District
United States (10)
Dana-Farber Cancer Institute
Boston , Massachusetts
Inova Schar Cancer Institute
Fairfax , Virginia
Banner MD Anderson Cancer Center at North Colorado Medical Center
Greeley , Colorado
University of Texas MD Anderson Cancer Center
Houston , Texas
Houston Methodist Hospital
Houston , Texas
Oncology Consultants P.A.
Houston , Texas
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis , Indiana
Banner MD Anderson Cancer Center at McKee Medical Center
Loveland , Colorado
Tennessee Oncology
Nashville , Tennessee
Washington University School of Medicine
St Louis , Missouri
Technical details
Status
Not yet recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Female only
Minimum age
18 Years
Healthy volunteers
No
Start date
01.05.2026
Completion date
01.12.2029
Registry ID
NCT07287098
Source
clinicaltrials.gov
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