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PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
Selective Estrogen Receptor Degrader
Imlunestrant
Phase
3
Enrolling

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*

Related Resources:
Molecule Overview Trial Enrollment
NCT05514054 show modal icon
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 cyclin-dependent kinase 4 and 6 (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.
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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