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  | ENROLLING

eMonarcHER; NCT04752332

Breast Cancer

CDK4 & 6 Inhibitor


A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Abemaciclib Plus Standard Adjuvant Endocrine Therapy in Participants With High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy*

NCT04752332
Key Inclusion Criteria
  • Confirmed hormone-receptor-positive (HR+), HER2-positive early breast cancer (EBC) in initial diagnostic tissue that is invasive and without evidence of disease recurrence or distant metastases
  • Prior definitive surgery of the primary breast tumor(s)
  • Available tumor tissue from breast or lymph node
  • Received a minimum of four cycles of chemotherapy in the neoadjuvant/adjuvant setting per standard-of-care therapy
  • Completed approximately 9 months to 1 year of standard HER2-targeted therapy without evidence of disease recurrence (neoadjuvant/adjuvant combined duration)
  • Received one of the following eligible HER2-targeted adjuvant regimens AND be randomized within 12 weeks of completing the regimen:
    • For participants treated with neoadjuvant therapy (chemotherapy with HER2-targeted therapy): single-agent adjuvant T-DM1
    • For participants not treated with neoadjuvant therapy: adjuvant pertuzumab with trastuzumab
  • High-risk disease, defined by one of the following:
    • For participants treated with neoadjuvant therapy (as defined above), pathologically detected axillary nodal disease in the surgical specimen
    • For participants not treated with neoadjuvant therapy, axillary node-positive disease meeting one of the following criteria:
      • Pathological tumor involvement in at least four ipsilateral axillary lymph nodes
      • Pathological tumor involvement in one to three ipsilateral axillary lymph node(s) and at least one of the following criteria:
        • Histological grade 3 disease
        • Primary invasive tumor size ≥5 cm determined pathologically
Key Exclusion Criteria
  • Breast cancer with disease recurrence or distant metastatic disease (including contralateral axillary lymph node), lymph node-negative status, pathological complete response from any prior systemic treatments for early breast cancer, or inflammatory breast cancer
  • Previous breast cancer (except ipsilateral ductal carcinoma in situ [DCIS] treated by locoregional therapy alone ≥5 years prior to study enrollment; contralateral DCIS treated by locoregional therapy at any time)
  • Other cancer being treated and/or not in complete remission within the last 5 years (except appropriately treated nonmelanomatous skin cancer or carcinoma in situ of cervix, bladder, or colon)
  • Females who are pregnant or lactating
  • History of venous thromboembolism
  • Other serious medical conditions, such as clinically significant cardiac abnormalities
  • Previously received treatment with:
    • Any CDK4 & 6 inhibitor
    • Prior adjuvant treatment with immunotherapy, tucatinib, neratinib, investigational HER2-directed therapy, or trastuzumab deruxtecan for treatment of breast cancer
    • Endocrine therapy (ET) (eg, tamoxifen, raloxifene, or aromatase inhibitor) for breast cancer prevention (without diagnosis of breast cancer)
    • Additional chemotherapy, anticancer ET, or HER2-targeted therapy beyond standard-of-care therapy for breast cancer at study enrollment
*
This clinical trial is being conducted globally.
Abemaciclib or placebo equivalent is administered PO BID on days 1-28 of a 28-day cycle.
Physician’s choice endocrine therapy is administered according to package label.
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.