CDK4/6 Inhibitor
Abemaciclib
Phase
3
Not Enrolling
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib Plus Fulvestrant to Placebo Plus Fulvestrant in Participants With HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy*
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Key Inclusion Criteria
- Hormone-receptor-positive (HR+), HER2-negative (HER2-) locally advanced or metastatic breast cancer
- Radiologic evidence of disease progression or recurrence either:
- On treatment with a cyclin-dependent kinase 4 and 6 (CDK4/6) with aromatase inhibitor (AI) as initial therapy for advanced disease, or
- On/after treatment with a CDK4/6 inhibitor plus endocrine therapy (ET) administered as adjuvant therapy for early-stage breast cancer
- Must be deemed appropriate for treatment with ET
- If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
- Measurable disease and/or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate renal, hematologic, and hepatic organ function
- Able to swallow capsules/tablets
Key Exclusion Criteria
- Visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
- Symptomatic or untreated central nervous system metastasis
- Received any systemic therapy between disease recurrence/progression and study screening
- Received more than one line of therapy for advanced or metastatic disease
- Prior chemotherapy for metastatic breast cancer (MBC)
- Prior treatment with fulvestrant, any investigational estrogen receptor (ER)-directed therapy (including selective ER degraders [SERDs] and non-SERDs), any PI3K, mTOR, or AKT inhibitor
*
This clinical trial is being conducted globally.
†
Abemaciclib or placebo equivalent is administered PO.
‡
Fulvestrant is administered intramuscularly.
