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 2

Next MONARCH 1; NCT02747004

Breast Cancer

CDK4 & 6 Inhibitor


A Randomized, Open-Label, Phase 2 Study of Abemaciclib Plus Tamoxifen or Abemaciclib Alone in Women With Previously Treated Hormone-Receptor-Positive, HER2-Negative, Metastatic Breast Cancer*

NCT02747004
Key Inclusion Criteria
  • Hormone-receptor-positive, HER2-negative breast cancer that has relapsed or progressed following endocrine therapy
  • Received prior treatment with at least two chemotherapy regimens, of which one, but no more than two, were in the metastatic setting
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Discontinuation of previous therapies for cancer (including aromatase inhibitors, antiestrogens, chemotherapy, radiotherapy, and immunotherapy) for at least 21 or 14 days for myelosuppressive or nonmyelosuppressive agents, respectively, prior to receiving study drug
  • Recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least grade 1) except for residual alopecia or peripheral neuropathy
  • Adequate organ function
  • Negative serum pregnancy test within 7 days prior to the first dose of study treatment and agrees to use highly effective precautions to prevent pregnancy during the study and for 12 weeks following the last dose of study treatment
  • Able to swallow oral medication
Key Exclusion Criteria
  • Clinical evidence or history of central nervous system metastasis
  • History of syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest
  • Active bacterial or fungal infection requiring intravenous antibiotics at the time of initiating study treatment and/or detectable viral infection
  • Prior treatment with a CDK4 & 6 inhibitor
  • Preexisting chronic condition resulting in persistent diarrhea
  • History of any other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix or breast) unless in complete remission with no therapy for a minimum of 3 years
*
This clinical trial is being conducted globally. 
Abemaciclib is administered PO Q12H on days 1-28 of a 28-day cycle.
Tamoxifen is administered PO QD over a 28-day cycle.
§
During cycle 1, prophylactic loperamide is administered PO QD with the first dose of abemaciclib. During cycle 2 and beyond, loperamide is administered at the investigator’s discretion and/or if clinically indicated.
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.