Phase 3  | 
 | Investigational Drug

EMBER-4; NCT05514054

Breast Cancer

Selective ER Degrader

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*

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Key Inclusion Criteria
  • Diagnosis of estrogen-receptor-positive (ER+), HER2-negative (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 endocrine therapy (ET) from time of adjuvant ET initiation
  • Participants may have received neoadjuvant chemotherapy and/or targeted therapy with a CDK4 & 6- or polyadenosine diphosphate-ribose polymerase (PARP)- inhibitor
  • Must have an increased risk of disease recurrence based on clinical-pathological risk features
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function
Key Exclusion Criteria
  • Any evidence of metastatic disease (including contralateral axillary lymph node [ALN]) or inflammatory breast cancer at primary breast cancer diagnosis
  • Greater than a 6-month consecutive gap in therapy during prior adjuvant ET
  • Participants who have completed or discontinued prior adjuvant ET >6 months prior to screening
  • History of previous breast cancer are excluded, except for ipsilateral ductal carcinoma in situ (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
  • Prior ET of any duration for breast cancer prevention (tamoxifen or aromatase inhibitors [AIs]) or raloxifene
  • History of any other cancer
  • Serious preexisting medical conditions 
This clinical trial is being conducted globally.
Imlunestrant is administered PO.
Endocrine therapy (investigator's choice of tamoxifen, anastrozole, letrozole, or exemestane) is administered per local approved label.
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The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.