DRUG
Imlunestrant
Given orally
Status
Recruiting
Phase
Phase 2
Enrollment
600
Locations
78
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
Given orally
DRUG
Given SC
DRUG
Given orally
Timeline
First posted
Dec 17, 2025
Study start
May 13, 2026
Primary completion
Jan 2029
Study completion
Dec 2029
Results posted
Not reported
Registry updated
Jul 17, 2026
Outcomes
Change from Baseline in Antigen Kiel (Ki-67) Expression
Time frame · Baseline, Day 29
Rate of Symptomatic Ovarian Cysts
Time frame · Up to Day 180
Change from Baseline in Estrogen Receptor (ER) Expression
Time frame · Baseline, Day 29
Change from Baseline in Progesterone Receptor (PR) Expression
Time frame · Baseline, Day 29
Rate of Complex Ovarian Cysts
Time frame · Up to Day 180
Eligibility
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 locations
Belgium · France · Germany · Ireland · Italy · Taiwan · United States. Showing up to 24 locations stored in the fast local snapshot.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Ironwood Cancer & Research Centers
Chandler, Arizona, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA Hematology/Oncology - Parkside
Santa Monica, California, United States
Banner MD Anderson Cancer Center at North Colorado Medical Center
Greeley, Colorado, United States
Banner MD Anderson Cancer Center at McKee Medical Center
Loveland, Colorado, United States
AdventHealth Altamonte Springs
Altamonte Springs, Florida, United States
Winship Cancer Institute
Atlanta, Georgia, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
New York Oncology Hematology, P.C.
Albany, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Wilmot Cancer Institute
Rochester, New York, United States
New York Cancer and Blood Specialists
Shirley, New York, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
Tennessee Oncology
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Oncology Consultants P.A.
Houston, Texas, United States
Publications
No PMID-linked publications were present in this registry snapshot.
Related trials
National Cancer Institute (NCI) · Anatomic Stage III Breast Cancer AJCC v8 · Anatomic Stage IV Breast Cancer AJCC v8
Phase 3
Active, not recruiting
608
2026-07
ECOG-ACRIN Cancer Research Group · Prostate Carcinoma
Phase 3
Active, not recruiting
27
2026-07
RenJi Hospital · Prostate Cancer · Prostate
Phase 2
Not yet recruiting
200
2026-07
Washington University School of Medicine · Breast Cancer · Cancer of Breast
Phase 2
Recruiting
50
2026-07
Aristotle University Of Thessaloniki · Metabolic Dysfunction-Associated Steatotic Liver Disease · Nonalcoholic Fatty Liver
Phase 4
Active, not recruiting
62
2026-07
Mayo Clinic · Recurrent Castration-Sensitive Prostate Carcinoma · Recurrent Prostate Cancer
Phase 2
Recruiting
532
2026-07
Novartis · Early Breast Cancer
Phase 3
Recruiting
1,400
2026-07
Henan Cancer Hospital · Breast Cancer
Not applicable
Not yet recruiting
456
2026-07
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.