Selective ER Degrader
Imlunestrant
Phase
3
Enrolling
A 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*
Related Resources:
Key Inclusion Criteria
- Diagnosis of estrogen-receptor-positive (ER+), HER2-negative locally advanced or metastatic breast cancer
- Disease that has demonstrated progression on or after an aromatase inhibitor alone or in combination with a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor
- Patients 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
- Response Evaluation Criteria in Solid Tumors (RECIST) evaluable disease (measurable disease and/or nonmeasurable bone-only disease)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate renal, hematologic, and hepatic organ function
- If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
- Able to swallow capsules/tablets
Key Exclusion Criteria
- Prior treatment with chemotherapy (except for neoadjuvant/adjuvant chemotherapy), fulvestrant, or any investigational ER-directed therapy (including SERDs and non-SERDs), any PI3K, mTOR, or AKT inhibitor
- Visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease
- Symptomatic or untreated brain metastasis
- Serious preexisting medical conditions
- Known allergic reaction against any of the components of the study treatment
*
This clinical trial is being conducted globally.
†
Imlunestrant is administered PO.
‡
Exemestane is administered PO.
§
Fulvestrant is administered intramuscularly.
‖
Abemaciclib is administered PO.
