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 hospitalizations. III. To estimate median (and 95% confidence interval \[CI\]) failure-free survival, progression-free survival and overall survival. IV. To describe the results of Was It Worth It (WIWI) and Overall Treatment Utility (OTU) questionnaires. V. To describe the rate of adherence to abemaciclib. VI. To determine average plasma steady-state abemaciclib Ctrough concentrations. VII. To evaluate the association of adherence rate with abemaciclib plasma t-rough concentrations. VIII. To describe associations between cancer-specific, comprehensive Geriatric Assessment (cGA) scores and the incidence of toxicities and their grade. EXPLORATORY OBJECTIVE: I. To determine the association between biomarkers of aging and grades 3 or higher toxicity. OUTLINE: Patients receive abemaciclib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, then every 6 months for 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
Given PO
Ancillary studies
City of Hope Medical Center
Duarte, California, United States
RECRUITINGDana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGRoswell Park Comprehensive Cancer Center
Buffalo, New York, United States
RECRUITINGIncidence 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.
Time frame: Up to 30 days post treatment
Incidence of toxicities
Toxicities will be graded and named according to CTCAE v. 5.0.
Time frame: Up to 30 days post treatment
Incidence of toxicities
Toxicities will be captured by Patient Reported Outcome (PRO)-CTCAE.
Time frame: Up to cycle 6
Dose reductions
Will assess rates of dose reductions.
Time frame: Up to cycle 6
Dose holds
Will assess rates of dose holds.
Time frame: Up to 30 days post treatment
Treatment discontinuations due to factors other than progression
Will assess rates of treatment discontinuations.
Time frame: Up to 30 days post treatment
Hospitalizations
Will assess rates of hospitalizations.
Time frame: Up to 2 years post treatment
Time to end of treatment
Will estimate median (and 95% confidence interval \[CI\]) failure-free survival using Kaplan-Meier estimates and through Cox regression to adjust for covariates.
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Time frame: Up to end of treatment
Progression free survival
Will estimate median (and 95% CI) progression-free survival using Kaplan-Meier estimates and through Cox regression to adjust for covariates.
Time frame: Up to 2 years post treatment
Overall survival
Will estimate median (and 95% CI) overall survival using Kaplan-Meier estimates and through Cox regression to adjust for covariates.
Time frame: Up to 2 years post treatment
Was It Worth It (WIWI) response
Will be assessed using the WIWI questionnaire.
Time frame: Up to end of treatment
Overall treatment utility (OTU) response
Will be assessed using the OTU questionnaire.
Time frame: Up to end of treatment
Adherence to abemaciclib
Adherence defined as taking 90% of scheduled doses per cycle. Scheduled doses are assigned doses for the participant which may vary per participant depending on whether or not there a hold in treatment. Adherence will be calculated based on consolidation of pill diary with returned unused pills, and, for City of Hope (COH) Duarte patients, Medication Event Monitoring bottle caps.
Time frame: Up to end of treatment
Average plasma steady-state abemaciclib C-trough concentrations
Time frame: Up to 2 years post treatment
Pharmacokinetic (PK) parameter of plasma trough concentration
Will evaluate the association of adherence rate with abemaciclib plasma trough concentrations.
Time frame: Up to 2 years post treatment
Geriatric assessment scores
Domains include: functional status, co-morbid medical conditions, cognitive function, nutritional status, social support and psychological state, and a review of medications.
Time frame: Up to 2 years post treatment
Incidence of toxicities attributable to agent
Graded by CTCAE v 5.0.
Time frame: Up to 2 years post treatment