๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-20

A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer (NCT07287098)

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

๐ŸŸข Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Eli Lilly and Company

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of Alabama at Birmingham โ€” Birmingham, Alabama

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (89 Sites)

Showing the first 25 of 89 sites.

  • University of Alabama at Birmingham โ€” Birmingham, Alabama
  • Ironwood Cancer & Research Centers โ€” Chandler, Arizona
  • Mayo Clinic in Arizona - Phoenix โ€” Phoenix, Arizona
  • City of Hope โ€” Duarte, California
  • City of Hope Orange County Lennar Foundation Cancer Center โ€” Irvine, California
  • USC/Norris Comprehensive Cancer Center โ€” Los Angeles, California
  • UCLA Hematology/Oncology - Parkside โ€” Santa Monica, California
  • Banner MD Anderson Cancer Center at North Colorado Medical Center โ€” Greeley, Colorado
  • Banner MD Anderson Cancer Center at McKee Medical Center โ€” Loveland, Colorado
  • AdventHealth Altamonte Springs โ€” Altamonte Springs, Florida
  • Mayo Clinic in Florida โ€” Jacksonville, Florida
  • Winship Cancer Institute โ€” Atlanta, Georgia
  • Indiana University Melvin and Bren Simon Cancer Center โ€” Indianapolis, Indiana
  • University of Kentucky Chandler Medical Center โ€” Lexington, Kentucky
  • Massachusetts General Hospital โ€” Boston, Massachusetts
  • Dana-Farber Cancer Institute โ€” Boston, Massachusetts
  • Mayo Clinic in Rochester, Minnesota โ€” Rochester, Minnesota
  • Washington University School of Medicine โ€” St Louis, Missouri
  • New York Oncology Hematology, P.C. โ€” Albany, New York
  • Memorial Sloan Kettering Cancer Center โ€” New York, New York
  • Wilmot Cancer Institute โ€” Rochester, New York
  • New York Cancer and Blood Specialists โ€” Shirley, New York
  • University of North Carolina Medical Center โ€” Chapel Hill, North Carolina
  • Cleveland Clinic โ€” Cleveland, Ohio
  • Providence Portland Medical Center โ€” Portland, Oregon

๐Ÿ“ž Contact the Study Coordinator

Phone: (317) 615-4559

Email: LillyTrials@Lilly.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Breast Neoplasms clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—