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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 29 days, 6 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The treatment in this group will last for up to 29 days."
  • "The treatment in this group will last for up to 6 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares imlunestrant with tamoxifen in women who have not gone through menopause and have early breast cancer that uses estrogen to grow (ER+) and is HER2-negative. Group 1 tests effects on cancer cells, with or without treatment to reduce ovary activity, for up to 29 days. Group 2 tests effects on the ovaries without treatment to reduce ovary activity, for up to 6 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Both groups: Women who have not gone through menopause and have ER+, HER2-negative breast cancer.
  • Both groups: Be fully active or able to do light work, have organs that work well enough, and be able to swallow pills.
  • Both groups: If you can become pregnant, use one highly effective birth control method without hormones during treatment and for the time required afterward.
  • Group 1: Have stage I–III invasive breast cancer, confirmed by a tissue test. At least 10% of tumor cells must show Ki-67, a sign of cell growth.
  • Group 1: Be willing and able to give tumor samples before and during treatment.
  • Group 2: Have early invasive breast cancer that was removed by surgery, with no signs it has spread to distant parts of the body.
  • Group 2: Have completed treatment for cancer in the breast and nearby area.
  • Group 2: Have had at least 4.5 years of hormone-blocking treatment after surgery, or at least 2 years with no more treatment to reduce ovary activity planned.

Who can't join

  • Both groups: Have cancer that has spread to distant parts of the body, breast cancer with an unknown starting site, or inflammatory breast cancer. Group 1 also excludes invasive cancer in both breasts.
  • Both groups: Have had both ovaries removed or treatment to permanently stop them from working, or currently take reproductive hormones.
  • Both groups: Have a serious medical condition or had major surgery within 28 days before study group assignment.
  • Both groups: Have a history of another cancer unless it has been fully in remission without treatment for at least 1 year. Exceptions include non-melanoma skin cancer and cancers that have not grown beyond their starting tissue. Group 1 also allows stage I uterine cancer.
  • Group 1: Have had any breast cancer treatment, radiation to the chest wall on the affected side, or estrogen-blocking treatment, even for bone thinning or cancer prevention.
  • Group 1: Plan to receive other cancer treatment before surgery during the study, or used a GnRH agonist—a medicine that lowers reproductive hormones—within 12 months before study group assignment.
  • Group 2: Have an ovarian cyst larger than 1 centimeter at screening.
  • Group 2: Finished or stopped hormone-blocking treatment after surgery more than 6 months before screening, or have ever used a SERD, a drug that breaks down estrogen receptors.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (34)

AL

  • University of Alabama at Birmingham · Birmingham, AL 35205Erica Stringer-Reasor · Principal investigatorMore trials in Birmingham

AZ

CA

CO

  • Banner MD Anderson Cancer Center at North Colorado Medical Center · Greeley, CO 80631 · Study contact · 970-810-3894Esther Mondo · Principal investigatorMore trials in Greeley
  • Banner MD Anderson Cancer Center at McKee Medical Center · Loveland, CO 80538 · Study contact · 970-810-3894Esther Mondo · Principal investigatorMore trials in Loveland

FL

GA

IN

  • Indiana University Melvin and Bren Simon Cancer Center · Indianapolis, IN 46202Rina Yadav · Principal investigatorMore trials in Indianapolis

KY

  • University of Kentucky Chandler Medical Center · Lexington, KY 40536Ruta Arays · Principal investigatorMore trials in Lexington

MA

MN

MO

  • Washington University School of Medicine · St Louis, MO 63110Rebecca Aft · Principal investigatorMore trials in St Louis

NC

  • University of North Carolina Medical Center · Chapel Hill, NC 27514Jeffrey Aldrich · Principal investigatorMore trials in Chapel Hill

NY

OH

OR

TN

TX

UT

VA

VT

  • The University of Vermont Medical Center Inc. · Burlington, VT 05401Peter Kaufman · Principal investigatorMore trials in Burlington