The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5,637
Administered orally.
Administered according to label instructions.
Invasive Disease Free Survival (IDFS)
IDFS, as defined by the STEEP System, was measured from the date of randomization to the date of first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, death attributable to any cause.
Time frame: Baseline to Recurrence or Death from Any Cause (Up to 32 Months)
IDFS for Participants With Ki-67 Index ≥20%
Outcome data will be provided after the study is completed.
Time frame: Baseline to Recurrence or Death from Any Cause (Approximately 10 Years)
Distant Relapse-Free Survival (DRFS)
Distant relapse-free survival is defined as the time from randomization to distant recurrence or death from any cause, whichever occurs first.
Time frame: Baseline to Distant Recurrence or Death from Any Cause (Up to 32 Months)
Overall Survival (OS)
Outcome data will be provided after the study is completed.
Time frame: Baseline to Death from Any Cause (Approximately 10 Years)
Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib
Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib
Time frame: Day 1 (2 hours post-dose), Days 30, 60, 90 post-dose
Change From Baseline on the Functional Assessment of Cancer Therapy - Breast (FACT-B)
Outcome data will be provided after the study is completed.
Time frame: Baseline, Follow Up (Approximately 3 Years)
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University of Alabama Birmingham
Birmingham, Alabama, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Arizona Oncology Associates, P.C. - HOPE
Goodyear, Arizona, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
The University of Arizona Cancer Center
Tucson, Arizona, United States
Yuma Regional Cancer Center
Yuma, Arizona, United States
St. Bernards Medical Center
Jonesboro, Arkansas, United States
Highlands Oncology Group
Springdale, Arkansas, United States
...and 609 more locations
Change From Baseline on the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)
Outcome data will be provided after the study is completed.
Time frame: Baseline, Follow Up (Approximately 3 Years)]
Change From Baseline on the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Outcome data will be provided after the study is completed.
Time frame: Baseline, Follow Up (Approximately 3 Years)]
Change From Baseline on the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L)
Outcome data will be provided after the study is completed.
Time frame: Baseline, Follow Up (Approximately 3 Years)]