A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer
NCT ID: NCT07287098
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
600 participants
INTERVENTIONAL
2026-01-31
2029-12-31
Brief Summary
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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. 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Imlunestrant
Imlunestrant will be given orally
Imlunestrant
Given Orally
Imlunestrant + Goserelin
Imlunestrant will be given orally and Goserelin will be given Subcutaneously (SC)
Imlunestrant + Goserelin
Imlunestrant will be given orally and Goserelin will be administered SC
pre-filled syringe
SC
Tamoxifen
Tamoxifen will be given orally
Tamoxifen 20 mg
Given Orally
Interventions
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Imlunestrant
Given Orally
Imlunestrant + Goserelin
Imlunestrant will be given orally and Goserelin will be administered SC
Tamoxifen 20 mg
Given Orally
pre-filled syringe
SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 \>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 5 years of any adjuvant ET.
* Be able to swallow capsules or tablets.
* Be premenopausal women
* Have adequate organ function.
* 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.
Exclusion Criteria
* 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
* 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 presence of ovarian cysts 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.
* 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.
18 Years
FEMALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Indiana University Health University Hospital
Indianapolis, Indiana, United States
Oncology Consultants P.A.
Houston, Texas, United States
Cliniques universitaires Saint-Luc
Brussels, , Belgium
Antwerp University Hospital
Edegem, , Belgium
UZ Leuven
Leuven, , Belgium
CHRU de Brest
Brest, , France
Centre de Cancérologie du Grand Montpellier
Montpellier, , France
Hôpital Privé Des Côtes d'Armor
Plérin, , France
Universitaetsklinikum Erlangen
Erlangen, , Germany
Ente Ospedaliero Ospedali Galliera
Genova, , Italy
Humanitas
Milan, , Italy
Humanitas Istituto Clinico Catanese
Misterbianco, , Italy
Nuovo Ospedale di Prato-S.Stefano
Prato, , Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, , Italy
Countries
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Central Contacts
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There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559)
Role: CONTACT
Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Related Links
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Lilly Trials
Other Identifiers
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2025-523258-15-00
Identifier Type: CTIS
Identifier Source: secondary_id
J2J-MC-JZLL
Identifier Type: OTHER
Identifier Source: secondary_id
27511
Identifier Type: -
Identifier Source: org_study_id
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