CDK4/6 Inhibitor
Abemaciclib
Phase
3
Not Enrolling
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) Plus LY2835219, a CDK4 & 6 Inhibitor, or Placebo in Postmenopausal Women With Hormone-Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting*
Related Resources:
Key Inclusion Criteria
- Hormone-receptor-positive (HR+), HER2-negative breast cancer
- Locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease
- Adequate organ function
- Postmenopausal status
- Measurable disease or nonmeasurable bone-only disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Discontinuation of previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture prior to randomization and recovery from the acute effects of therapy
- Able to swallow capsules
Key Exclusion Criteria
- Visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
- Inflammatory breast cancer
- Clinical evidence or a history of central nervous system metastasis
- Currently receiving or has previously received chemotherapy or endocrine therapy for locoregionally recurrent or metastatic breast cancer
- Prior (neo)adjuvant endocrine therapy (eg, antiestrogens or aromatase inhibitors) with a disease-free interval ≤12 months from completion of treatment
- Prior treatment with everolimus or any cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor
- Initiation of bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents within 7 days of randomization
- Currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study
- Treatment with a drug that has not received regulatory approval for any indication with 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively
- Major surgery within 14 days prior to randomization
*
This clinical trial is being conducted globally.
†
Abemaciclib 150 mg or placebo equivalent is administered PO Q12H.
‡
Anastrozole 1 mg is administered PO QD.
§
Letrozole 2.5 mg is administered PO QD.
