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

Phase
Recruitment status
Participants
Lead sponsor
Eli Lilly and Company
Start date
Number of sites

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.
Acronym
Short title
A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer
Official title
preEMBER: A Phase 2, Open-label Study Evaluating Imlunestrant in Premenopausal Women With Estrogen Receptor-Positive, HER2-Negative Breast Cancer

Control arm
Active comparator
Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Participants
Participant count basis
Planned participants
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Eli Lilly and Company
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design

  1. Change from Baseline in Antigen Kiel (Ki-67) Expression

    Timeframe: Baseline, Day 29

  2. Rate of Symptomatic Ovarian Cysts

    Timeframe: Up to Day 180

  1. Change from Baseline in Estrogen Receptor (ER) Expression

    Timeframe: Baseline, Day 29

  2. Change from Baseline in Progesterone Receptor (PR) Expression

    Timeframe: Baseline, Day 29

  3. Rate of Complex Ovarian Cysts

    Timeframe: Up to Day 180

Sources for outcomes

Sex
Female
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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.

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.
Sources for eligibility

  • University of Alabama at BirminghamBirmingham, United StatesNot yet recruiting
  • Ironwood Cancer & Research CentersChandler, United StatesSuspended
  • Mayo Clinic in Arizona - PhoenixPhoenix, United StatesNot yet recruiting
  • City of HopeDuarte, United StatesNot yet recruiting
  • City of Hope Orange County Lennar Foundation Cancer CenterIrvine, United StatesNot yet recruiting
  • USC/Norris Comprehensive Cancer CenterLos Angeles, United StatesNot yet recruiting
  • UCLA Hematology/Oncology - ParksideSanta Monica, United StatesNot yet recruiting
  • Banner MD Anderson Cancer Center at North Colorado Medical CenterGreeley, United StatesNot yet recruiting
  • Banner MD Anderson Cancer Center at McKee Medical CenterLoveland, United StatesNot yet recruiting
  • AdventHealth Altamonte SpringsAltamonte Springs, United StatesNot yet recruiting
  • Mayo Clinic in FloridaJacksonville, United StatesNot yet recruiting
  • Winship Cancer InstituteAtlanta, United StatesNot yet recruiting
  • Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, United StatesRecruiting
  • University of Kentucky Chandler Medical CenterLexington, United StatesNot yet recruiting
  • Massachusetts General HospitalBoston, United StatesNot yet recruiting
  • Dana-Farber Cancer InstituteBoston, United StatesNot yet recruiting
  • Mayo Clinic in Rochester, MinnesotaRochester, United StatesNot yet recruiting
  • Washington University School of MedicineSt Louis, United StatesNot yet recruiting
  • New York Oncology Hematology, P.C.Albany, United StatesNot yet recruiting
  • Memorial Sloan Kettering Cancer CenterNew York, United StatesNot yet recruiting
  • Wilmot Cancer InstituteRochester, United StatesNot yet recruiting
  • New York Cancer and Blood SpecialistsShirley, United StatesRecruiting
  • University of North Carolina Medical CenterChapel Hill, United StatesNot yet recruiting
  • Cleveland ClinicCleveland, United StatesNot yet recruiting
  • Providence Portland Medical CenterPortland, United StatesNot yet recruiting

And 64 more, listed on the interactive page.

Sources for sites

  • 2025
  • 2025-523258-15-00
  • J2J-MC-JZLL
Sources for references

Related records

Drugs (3)

Lead sponsors (1)

Conditions (1)

Targets (2)