monarcHER; NCT02675231

Breast Cancer

CDK4 & 6 Inhibitor

A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib Plus Trastuzumab With or Without Fulvestrant to Standard-of-Care Chemotherapy of Physician’s Choice Plus Trastuzumab in Women With Hormone-Receptor-Positive, HER2-Positive Locally Advanced or Metastatic Breast Cancer*

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Key Inclusion Criteria
  • Unresectable, locally advanced recurrent or metastatic hormone-receptor-positive (HR+), HER2-positive breast cancer
  • Availability of tumor tissue sample
  • Measurable and/or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Previous treatment with at least two HER2-directed therapies for advanced disease, and received trastuzumab emtansine and a taxane in any disease setting
  • Postmenopausal status 
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function
  • Left ventricular ejection fraction of 50% or higher at baseline 
  • Negative serum pregnancy test within 14 days prior to randomization and must agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following the last dose of abemaciclib if postmenopausal status is due to ovarian suppression due to a GnRH agonist or radiation
  • Discontinuation of all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and endocrine therapy), except trastuzumab, for at least 21 or 14 days for myelosuppressive or nonmyelosuppressive agents, respectively
  • Discontinuation of previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture at least 2 weeks prior to randomization
  • Able to swallow capsules
Key Exclusion Criteria
  • Visceral crisis
  • Known central nervous system metastases that are untreated, symptomatic, or require steroids to control symptoms
  • Prior treatment with any CDK4 & 6 inhibitor
  • Major surgery within 14 days prior to randomization
  • Prior treatment with a drug that has not received regulatory approval for any indication within 14 to 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively
  • Serious preexisting medical conditions that would preclude participation in this study
  • History within the last 6 months of symptomatic congestive heart failure, myocardial infarction, or unstable angina
  • Syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest within the last 12 months
  • History of any other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission with no therapy for a minimum of 3 years
  • Active bacterial, fungal, or viral infection
  • Any live virus vaccination within 28 days prior to randomization
  • Hypersensitivity to trastuzumab, murine proteins, fulvestrant, or any excipients
This clinical trial is being conducted globally.
Abemaciclib is administered PO Q12H on days 1-21 of a 21-day cycle.
Fulvestrant is administered intramuscularly on days 1, 15, and 29, then Q4W.
Trastuzumab is administered intravenously (IV) on day 1 of a 21-day cycle, then a maintenance dose IV infusion on day 1 of each subsequent cycle.
Standard-of-care, single-agent chemotherapy of physician's choice is administered according to the product label.
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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.