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Clinical Trials in Ireland / NCT07287098
Recruiting Phase 2

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 · tracked via the Priya Life Science Ireland tracker
Sponsor
Eli Lilly and Company
Phase
Phase 2
Started
2026-05-13
Last updated
2026-09-04

Condition(s) studied

Breast Neoplasms

Investigational drug(s) / intervention(s)

ImlunestrantGoserelinTamoxifen 20 mg

Imlunestrant: Given orally

Goserelin: Given SC

Tamoxifen 20 mg: Given orally

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (89)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Not Yet Recruiting
Ironwood Cancer & Research Centers Chandler Arizona Suspended
Mayo Clinic in Arizona - Phoenix Phoenix Arizona Not Yet Recruiting
City of Hope Duarte California Not Yet Recruiting
City of Hope Orange County Lennar Foundation Cancer Center Irvine California Not Yet Recruiting
USC/Norris Comprehensive Cancer Center Los Angeles California Not Yet Recruiting
UCLA Hematology/Oncology - Parkside Santa Monica California Not Yet Recruiting
Banner MD Anderson Cancer Center at North Colorado Medical Center Greeley Colorado Not Yet Recruiting
Banner MD Anderson Cancer Center at McKee Medical Center Loveland Colorado Not Yet Recruiting
AdventHealth Altamonte Springs Altamonte Springs Florida Not Yet Recruiting
Mayo Clinic in Florida Jacksonville Florida Not Yet Recruiting
Winship Cancer Institute Atlanta Georgia Not Yet Recruiting
Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana Recruiting
University of Kentucky Chandler Medical Center Lexington Kentucky Not Yet Recruiting
Massachusetts General Hospital Boston Massachusetts Not Yet Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Not Yet Recruiting
Mayo Clinic in Rochester, Minnesota Rochester Minnesota Not Yet Recruiting
Washington University School of Medicine St Louis Missouri Not Yet Recruiting
New York Oncology Hematology, P.C. Albany New York Not Yet Recruiting
Memorial Sloan Kettering Cancer Center New York New York Not Yet Recruiting
Wilmot Cancer Institute Rochester New York Not Yet Recruiting
New York Cancer and Blood Specialists Shirley New York Recruiting
University of North Carolina Medical Center Chapel Hill North Carolina Not Yet Recruiting
Cleveland Clinic Cleveland Ohio Not Yet Recruiting
Providence Portland Medical Center Portland Oregon Not Yet Recruiting
Providence St. Vincent Medical Center Portland Oregon Not Yet Recruiting
Tennessee Oncology Nashville Tennessee Recruiting
University of Texas MD Anderson Cancer Center Houston Texas Recruiting
Houston Methodist Hospital Houston Texas Not Yet Recruiting
Oncology Consultants P.A. Houston Texas Recruiting
Baylor Scott & White Medical Center - Round Rock Round Rock Texas Not Yet Recruiting
Huntsman Cancer Institute Salt Lake City Utah Not Yet Recruiting
The University of Vermont Medical Center Inc. Burlington Vermont Not Yet Recruiting
University of Virginia Health System Charlottesville Virginia Not Yet Recruiting
Inova Schar Cancer Institute Fairfax Virginia Not Yet Recruiting
Cliniques universitaires Saint-Luc Brussels Belgium Not Yet Recruiting
Antwerp University Hospital Edegem Belgium Not Yet Recruiting
UZ Leuven Leuven Belgium Not Yet Recruiting
CHRU de Brest Brest France Not Yet Recruiting
Centre de Cancérologie du Grand Montpellier Montpellier France Not Yet Recruiting

+ 49 more sites — see the full list on the official registry below.

More Eli Lilly and Company trials in Ireland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07287098 on ClinicalTrials.gov ↗ ← All trials in Ireland