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Phase 2Recruiting

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

Sponsored by Eli Lilly and Company

About this 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.

Where this study is enrolling (20)

  • Mayo Clinic in Arizona - Phoenix

    Phoenix, Arizona

    Call +1 480-515-6296

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  • UCLA Hematology/Oncology - Parkside

    Santa Monica, California

    Call 310-998-4747

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  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California

    Call 323-397-5954

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  • Banner MD Anderson Cancer Center at North Colorado Medical Center

    Greeley, Colorado

    Call 970-810-3894

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  • Banner MD Anderson Cancer Center at McKee Medical Center

    Loveland, Colorado

    Call 970-810-3894

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Show all 20 locations

  • Mayo Clinic in Florida

    Jacksonville, Florida

    Call 904-953-2000

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  • Winship Cancer Institute

    Atlanta, Georgia

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  • Dana-Farber Cancer Institute

    Boston, Massachusetts

    Call 617-632-2335

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  • Massachusetts General Hospital

    Boston, Massachusetts

    Call 617-726-6500

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  • Mayo Clinic in Rochester, Minnesota

    Rochester, Minnesota

    Call 507-284-2511

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  • New York Cancer and Blood Specialists

    Shirley, New York

    Call 631-675-5075

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  • Wilmot Cancer Institute

    Rochester, New York

    Call 585-275-4823

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  • Providence St. Vincent Medical Center

    Portland, Oregon

    Call 503-215-5696

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  • Providence Portland Medical Center

    Portland, Oregon

    Call 503-215-5696

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  • Baylor Scott & White Medical Center - Round Rock

    Round Rock, Texas

    Call 512-509-0200

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  • Oncology Consultants P.A.

    Houston, Texas

    Call 855-827-9525

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  • Houston Methodist Hospital

    Houston, Texas

    Call 713.790.3311

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  • University of Texas MD Anderson Cancer Center

    Houston, Texas

    Call 877-632-6789

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  • Huntsman Cancer Institute

    Salt Lake City, Utah

    Call 801-585-0236

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  • University of Virginia Health System

    Charlottesville, Virginia

    Call 434-924-9333

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Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.