City of Hope Medical Center
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.
PRIMARY OBJECTIVE: I. To estimate the incidence of grade 3 or higher toxicities attributed to abemaciclib monotherapy in adults aged 70 or older with hormone receptor positive metastatic breast cancer. SECONDARY OBJECTIVES: I. To describe the full toxicity profile including all grade 2 and higher adverse events, and patient-reported adverse events (AEs) using Patients Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) measures. II. To describe rates of dose reductions, dose holds, treatment discontinuations due to factors other than progression, and hospitalizat…
Inclusion Criteria: * Documented informed consent of the participant * Age \>= 70 years * Life expectancy \> 6 months * Ability to read and understand English or Spanish * Measurable or non-measurable disease * Histologically or cytologically confirmed diagnosis of: * Estrogen-receptor positive and/or progesterone receptor positive breast cancer determined by immunohistochemistry (IHC) methods according to the local institution standard protocol * HER2-negative breast cancer defined as negative if the IHC status is 0 or 1+, or if IHC is 2+ and in situ hybridization assay is negative per…
Given PO
Ancillary studies