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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

RecruitingPhase 2

preEMBER: A Phase 2, Open-label Study Evaluating Imlunestrant in Premenopausal Women With Estrogen Receptor-Positive, HER2-Negative Breast Cancer

Who can join

Ages 18 and older · Women

Full 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.

About the 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.

What is being tested

Sponsor: Eli Lilly and Company · Participants: 600 · Started: May 13, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07287098

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham, Birmingham (Not yet recruiting)
ArizonaMayo Clinic in Arizona - Phoenix, Phoenix (Not yet recruiting)
CaliforniaCity of Hope, Duarte (Not yet recruiting)
City of Hope Orange County Lennar Foundation Cancer Center, Irvine (Not yet recruiting)
USC/Norris Comprehensive Cancer Center, Los Angeles (Not yet recruiting)
UCLA Hematology/Oncology - Parkside, Santa Monica (Not yet recruiting)
ColoradoBanner MD Anderson Cancer Center at North Colorado Medical Center, Greeley (Not yet recruiting)
Banner MD Anderson Cancer Center at McKee Medical Center, Loveland (Not yet recruiting)
FloridaAdventHealth Altamonte Springs, Altamonte Springs (Not yet recruiting)
Mayo Clinic in Florida, Jacksonville (Not yet recruiting)
GeorgiaWinship Cancer Institute, Atlanta (Not yet recruiting)
IndianaIndiana University Melvin and Bren Simon Cancer Center, Indianapolis
KentuckyUniversity of Kentucky Chandler Medical Center, Lexington (Not yet recruiting)
MassachusettsDana-Farber Cancer Institute, Boston (Not yet recruiting)
Massachusetts General Hospital, Boston (Not yet recruiting)
MinnesotaMayo Clinic in Rochester, Minnesota, Rochester (Not yet recruiting)
MissouriWashington University School of Medicine, St Louis (Not yet recruiting)
New YorkMemorial Sloan Kettering Cancer Center, New York (Not yet recruiting)
Wilmot Cancer Institute, Rochester (Not yet recruiting)
New York Cancer and Blood Specialists, Shirley
North CarolinaUniversity of North Carolina Medical Center, Chapel Hill (Not yet recruiting)
OregonProvidence Portland Medical Center, Portland (Not yet recruiting)
Providence St. Vincent Medical Center, Portland (Not yet recruiting)
TennesseeTennessee Oncology, Nashville
TexasHouston Methodist Hospital, Houston (Not yet recruiting)
Oncology Consultants P.A., Houston
University of Texas MD Anderson Cancer Center, Houston
Baylor Scott & White Medical Center - Round Rock, Round Rock (Not yet recruiting)
UtahHuntsman Cancer Institute, Salt Lake City (Not yet recruiting)
VermontThe University of Vermont Medical Center Inc., Burlington (Not yet recruiting)
VirginiaUniversity of Virginia Health System, Charlottesville (Not yet recruiting)
Inova Schar Cancer Institute, Fairfax (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.