Oncology Pipeline

For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. In 2019 Lilly created Loxo Oncology at Lilly, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new medicines that work in early clinical development and will matter to patients.

Phase 3

MONARCH 3; NCT02246621

Breast Cancer

CDK4 & 6 Inhibitor


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*

NCT02246621
Key Inclusion Criteria
  • Hormone-receptor-positive, 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 at least 2 weeks 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 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.
Contact the Lilly Oncology Clinical Trial Navigation Service

Visit www.clinicaltrials.gov for more information on this trial.

The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.