A 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 (EMBER-4)

The purpose of this research study is to see if imlunestrant is safe and effective for the treatment of ER+, HER2- early breast cancer. The researchers want to confirm the right dose levels of imlunestrant and find out what effects (good and bad) imlunestrant has on patients who have previously received 2 to 5 years of adjuvant endocrine therapy.

Inova Schar Cancer Institute
A division of Inova Fairfax Hospital
8081 Innovation Park Drive
Fairfax, VA 22031

Inova Schar Cancer Institute
3580 Joseph Siewick Drive
Fairfax, VA 22033

• Participants must be 18 years of age
• A diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis
• Participants with bilateral breast cancer (diagnosis of invasive tumors in both breasts simultaneously or within 6 months of each other) can be eligible if all lesions tested on both sides are ER+, HER2- (as defined in Inclusion Criterion #2) and adequate surgery has been performed in both breasts
• Undergone definitive loco-regional therapy (surgery, with or without, radiation therapy where appropriate/per guidelines) of the primary breast tumor(s). 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 must have an increased risk of disease recurrence based on clin-path risk features
• For female participants: both pre-/peri- and postmenopausal status is allowed
• Additional eligibility in protocol.

• 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 with a history of previous breast cancer are excluded, with the exception of ipsilateral DCIS treated by locoregional therapy alone ≥5 years ago
• Pregnancy, 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
• Concurrent exogenous reproductive hormone therapy, for example, birth control pills, hormone replacement therapy, or megestrol acetate
• Previous ET of any duration for breast cancer prevention (tamoxifen or AIs) or raloxifene
• Serious cardiac conditions, such as
  • congestive heart failure
  • New York Heart Association Class III/IV heart disease
  • unstable angina pectoris
  • myocardial infarction within the last 3 months
  • valvulopathy that is severe or moderate, or deemed clinically significant
  • arrhythmias that are symptomatic or require treatment, not including patients with rate-controlled atrial fibrillation
  • cerebrovascular accident (stroke) within the last 3 months
• Autologous or allogeneic stem cell transplant
• Active bacterial or fungal infection, or detectable viral infection, for example, HIV or viral hepatitis. Screening is required for enrollment
• Known allergic reaction against any of the components of the study treatment
• Additional ineligibility in protocol.

For additional information, please go to:  https://clinicaltrials.gov/ct2/show/NCT05514054