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PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
CDK4/6 Inhibitor
Abemaciclib
Phase
3
Active, not recruiting
Recruiting Info
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 Settinga
Related Resources:
MONARCH 3
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
a
This clinical trial is being conducted globally. 
b
Abemaciclib 150 mg or placebo equivalent is administered orally Q12H.
c
Administered at 1 mg orally QD.
d
Administered at 2.5 mg orally QD.
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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