Comparing Imlunestrant to Standard Hormone Therapy for Early Breast Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of imlunestrant compared to standard endocrine therapies in patients with early-stage, estrogen receptor positive (ER+), and human epidermal receptor 2 negative (HER2-) breast cancer. Participants must have previously undergone 2 to 5 years of endocrine therapy and are at a higher risk for cancer recurrence. The study aims to assess how well imlunestrant can prevent cancer from returning over a potential duration of up to 10 years.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

* Have any evidence of metastatic disease (including contralateral ALN) or inflammatory breast cancer at primary breast cancer diagnosis.
* Participants with more than a 6-month consecutive gap in therapy during the course of prior adjuvant ET.
* Participants who have completed or discontinued prior adjuvant ET \>6 months prior to screening.
* Participants with a history of previous breast cancer are excluded, with the exception of ipsilateral DCIS treated by locoregional therapy alone ≥5 years ago.
* Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of study intervention.
* Participant has previously received ET of any duration for breast cancer prevention (tamoxifen or AIs) or raloxifene.
* Participants with a history of any other cancer.
* Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study.

Where it's running

• USO - Southern Cancer Center
  Daphne, Alabama, United States Recruiting
• Clearview Cancer Institute
  Huntsville, Alabama, United States Recruiting
• Infirmary Cancer Care
  Mobile, Alabama, United States Recruiting
• Banner MD Anderson Cancer Center
  Gilbert, Arizona, United States Recruiting
• USO - Arizona Oncology Associates - HAL
  Glendale, Arizona, United States Recruiting
• St. Joseph's Hospital and Medical Center
  Phoenix, Arizona, United States Recruiting

+633 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
• Email: clinical_inquiry_hub@lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.