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A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer

Status
Active
Cancer Type
Breast Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05514054
Protocol IDs
18459 (primary)
NCI-2022-08126
2022-501007-28
J2J-MC-JZLH
Study Sponsor
Eli Lilly and Company

Summary

The main purpose of this study is to measure how well imlunestrant works compared to
standard hormone therapy in participants with early breast cancer that is estrogen
receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants
must have already taken endocrine therapy for two to five years and must have a
higher-than-average risk for their cancer to return. Study participation could last up to
10 years.

Eligibility

  1. Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis.
  2. Participants must have received at least 24 months but not more than 60 months of any adjuvant ET, from time of adjuvant ET initiation.
  3. Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy with a CDK4/6- or PARP- inhibitor.
  4. Must have an increased risk of disease recurrence based on clinical-pathological risk features.
  5. Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale.
  6. Have adequate organ function.

Treatment Sites in Georgia

Northside Hospital Cancer Institute


1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.