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Official Title

EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence

Phase
Phase 3
Sponsor
Eli Lilly and Company
Enrollment
8,000
Timeline
Oct 2022 → Mar 2032
About This Study

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 Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 1Have any evidence of metastatic disease (including contralateral ALN) or inflammatory breast cancer at primary breast cancer diagnosis.
  • 2Participants with more than a 6-month consecutive gap in therapy during the course of prior adjuvant ET.
  • 3Participants who have completed or discontinued prior adjuvant ET \>6 months prior to screening.
  • 4Participants with a history of previous breast cancer are excluded, with the exception of ipsilateral DCIS treated by locoregional therapy alone ≥5 years ago.
  • 5Pregnant, 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.
  • 6Participant has previously received ET of any duration for breast cancer prevention (tamoxifen or AIs) or raloxifene.
  • 7Participants with a history of any other cancer.
  • 8Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study.

Locations

674 sites participating in this study

Winship Cancer Institute, Emory University

Atlanta, Georgia 30322

Recruiting

Manali Bhave

USO - Southern Cancer Center

Daphne, Alabama 36526

Recruiting

Michael Meshad

Clearview Cancer Institute

Huntsville, Alabama 35805

Recruiting

Marshall Schreeder

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →