EMBER-3: This phase III study is measuring how well a new hormone therapy (imlunestrant) works compared to standard hormone therapy (exemestane or fulvestrant) and combination therapy (imlunestrant + abemaciclib) in people with ER+/HER2- breast cancerA Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy

Inclusion

• Have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer

• Have disease that has demonstrated progression on or after an aromatase inhibitor alone or in combination with a cyclin-dependent kinase (CDK)4/6 inhibitor

  -- Participants are expected to have received prior treatment with a CDK4/6 inhibitor, if this treatment is approved and can be reimbursed

• Must be deemed appropriate for treatment with endocrine therapy
• If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
• Have RECIST evaluable disease (measurable disease and/or nonmeasurable bone-only disease)
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
• Have adequate renal, hematologic, and hepatic organ function
• Must be able to swallow capsules/tablets