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

NCT03703466

Breast Cancer

CDK4 & 6 Inhibitor


An Open-Label, Randomized Phase 2 Study of the Impact of Food on Tolerability When Receiving Abemaciclib for Patients With Previously Treated Hormone-Receptor-Positive, HER2-Negative Metastatic Breast Cancer*

NCT03703466
Key Inclusion Criteria
  • Recurrent, locally advanced, unresectable or metastatic hormone-receptor-positive, HER2-negative breast cancer
  • Disease progression following antiestrogen therapy and prior treatment with at least one chemotherapy regimen in the locally advanced or metastatic setting
  • No prior treatment with any CDK4 & 6 inhibitor
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Discontinued all previous treatments for cancer and recovered from the acute effects of therapy
  • Adequate organ function
  • Males with partners of child-bearing potential or females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 weeks following the last dose of study drug
  • Those with child-bearing potential must have a negative serum pregnancy status within 7 days of the first dose of study drug
  • Life expectancy of ≥12 weeks
  • Able to swallow oral medications
Key Exclusion Criteria
  • Currently receiving an investigational treatment
  • Serious preexisting medical conditions as judged by the investigator
  • History of syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest
  • Symptomatic central nervous system malignancy or metastasis
  • 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
  • Major surgery within 14 days prior to the first dose of study drug
  • Pregnant or breastfeeding
  • Received investigational therapy within 14 or 21 days prior to the first dose of study drug for nonmyelosuppressive or myelosuppressive agents, respectively
  • Symptomatic HIV infection or activated/reactivated hepatitis A, B, or C
*
This clinical trial is being conducted outside of the United States. 
Abemaciclib is administered PO Q12H.
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.