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*

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Key Inclusion Criteria
  • Hormone-receptor-positive (HR+), 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
  • Presence of 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
  • Discontinued previous therapies for cancer (including aromatase inhibitors, antiestrogens, chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and 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 3 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.
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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.