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

monarchE; NCT03155997

Breast Cancer

CDK4 & 6 Inhibitor


A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High-Risk, Node-Positive, Early-Stage, Hormone-Receptor-Positive, Human Epidermal Receptor 2-Negative Breast Cancer*

NCT03155997
Key Inclusion Criteria
  • Hormone-receptor-positive, HER2-negative, node-positive, early-stage resected invasive breast cancer without evidence of distant metastases
  • Underwent definitive surgery of the primary breast tumor(s) within 16 months of randomization
  • Availability of tumor tissue from breast or lymph node for biomarker analysis prior to randomization
  • Pathologic axillary lymph node involvement with at least one of the following:
    • Four or more positive axillary lymph nodes
    • Tumor size of at least 5 cm
    • At least 8 points on the Bloom-Richardson grading system
    • Ki-67 index by central analysis of ≥20%
  • Up to 12 weeks of endocrine therapy following the last nonendocrine therapy
  • Recovery (grade ≤1) from the acute effects of chemotherapy and radiotherapy, and surgical side effects following definitive breast surgery
  • Female (regardless of menopausal status) or male ≥18 years of age, or per local regulations
  • Negative blood pregnancy test and must agree to use highly effective contraceptive methods
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function
  • Able to swallow oral medications
Key Exclusion Criteria
  • Metastatic disease (including contralateral axillary lymph nodes) or lymph node-negative breast cancer
  • Inflammatory breast cancer
  • History of breast cancer (except ipsilateral ductal carcinoma in situ treated by locoregional therapy alone) ≥5 years prior to study entry
  • History of any other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission with no therapy for a minimum of 5 years, or at low risk of recurrence if diagnosed within the last 5 years
  • Pregnant or breastfeeding
  • Previous treatment with any CDK4 & 6 inhibitor
  • Currently receiving concurrent exogenous hormone therapy
  • Previously received endocrine therapy for breast cancer prevention
  • Serious preexisting medical conditions as judged by the investigator 
  • History of syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, or sudden cardiac arrest
  • History of venous thromboembolic event
  • Active systemic infections, or fungal or detectable viral infections requiring systemic therapy
  • Received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer
*
This clinical trial is being conducted globally. 
Abemaciclib is administered PO.
Standard adjuvant endocrine therapy is administered according to label instructions.
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.