Current partner codePEPTIDESDE
NCT07287098·Phase 2·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 2

Enrollment

600

Locations

78

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Imlunestrant

Given orally

DRUG

Goserelin

Given SC

DRUG

Tamoxifen 20 mg

Given orally

Timeline

From registration to results.

  1. First posted

    Dec 17, 2025

  2. Study start

    May 13, 2026

  3. Primary completion

    Jan 2029

  4. Study completion

    Dec 2029

  5. Results posted

    Not reported

  6. Registry updated

    Jul 17, 2026

Outcomes

What the study measures.

Primary 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

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
FEMALE
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.

Study locations

78 registered sites.

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

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Goserelin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.