Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer

February 22, 2018
MonarchE, B-58
Breast Cancer
Alexander Hantel, MD
Edward Cancer Center - Naperville
Edward Cancer Center - Plainfield
Nancy Knowles Cancer Center - Elmhurst

The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.

Sponsor: Eli Lilly & NSABP Foundation


  • Confirmed HR+, HER2-, early stage resected invasive breast cancer without evidence of distant metastases.
  • Pathologic lymph node involvement with a higher risk of recurrence Within 16 months from the time of definitive breast cancer surgery.
  • No metastatic or node-negative disease.
  • No history of previous breast cancer, with the exception of ipsilateral ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago. Participants with a history of contralateral DCIS treated by local regional therapy at any time may be eligible. Participants with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years from the date of randomization are excluded.
  • No previous endocrine therapy for breast cancer prevention

10 years

Accepting Participants
Kathy Seymour, BSN