This phase IIa trial studies the side effects of abemaciclib monotherapy in treating patients age 70 years and older with hormone receptor positive, HER2 negative breast cancer that has spread to other places in the body.
Documented informed consent of the participant
Age >= 70 years
Life expectancy > 6 months
Ability to read and understand English or Spanish
Major surgery within 14 days prior to receiving study drug or has not recovered from major side effect
Patient is currently receiving any of the prohibited medications detailed below and cannot be discontinued 7 days prior to starting study drug
Other investigational therapy should be given to participants
Anticancer agents other than the study medications administered as part of this study protocol should be given to participants. If such agents are required for a participant then the participant must first be withdrawn from the study
Single group
Abemaciclib
DrugGiven PO
Questionnaire Administration
Other interventionAncillary studies
Incidence of grade 3 or higher toxicities
Adverse events will be characterized using the descriptions and grading scales found in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v). 5.0.
Incidence of toxicities
Toxicities will be graded and named according to CTCAE v. 5.0.
Incidence of toxicities
Toxicities will be captured by Patient Reported Outcome (PRO)-CTCAE.
Dose reductions
Will assess rates of dose reductions.
Dose holds
Will assess rates of dose holds.
Biological age via deoxyribonucleic acid (DNA) methylation level
Genome-wide methylome and transcriptome analyses
Incidence of toxicities at least possibly attributable to agent
Graded by CTCAE v 5.0.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
