The purpose of this study is to evaluate the biological effects of abemaciclib in combination with anastrozole and compare those to the effects of abemaciclib alone and anastrozole alone in the tumors of postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) negative breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
224
Administered orally
Administered orally
Administered orally
Percent Change From Baseline to 2 Weeks in Ki67 Expression
Tumor tissue collected through a core biopsy at baseline and at the end of cycle 1 was used to determine Ki67 expression. Ki67 expression is defined as the percent of cells staining positive by validated central assay.
Time frame: Baseline, 2 Weeks
Percentage of Participants With Pathologic Complete Response (pCR)
pCR is defined as absence of invasive cancer in the breast and sampled regional lymph nodes.
Time frame: From Start of Treatment Up to 16 Weeks
Percentage of Participants With Complete Response (CR) or Partial Response (PR): Clinical Objective Response
Clinical objective response is defined as the percentage of participants with the best overall response rate (ORR) with a best OR of CR or PR, according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1. ORR is recorded from the start of the study treatment until the earliest of objective progression or start of new anticancer therapy. A responder depends on target and non-target disease and the appearance of new lesions. CR is defined as the disappearance of all non-target lesions. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. All lymph nodes are non-pathological or normal in size (\<10mm short axis). Progressive disease (PD) is a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, a relative increase of 20%, the sum must also demonstrate an absolute increase of 5 mm.
Time frame: From Start of Treatment to Objective Progression or Start of New Anticancer Therapy (Up to 16 Weeks)
Percentage of Participants With Complete Radiologic Response or Partial Radiological Response: Radiological Response
Radiological response is the percentage of participants with CR or, PR according to RECIST v.1.1. A responder is defined as any participant who exhibits a CR or PR. CR is the disappearance of all target lesions. PR is a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. PD is 20% increase in the sum of diameters of target lesions taking as reference the smallest sum and the appearance of 1 or more new lesions.
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Comprehensive Blood and Cancer Center
Bakersfield, California, United States
University of California-San Diego
La Jolla, California, United States
SMO TRIO -Translational Research
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
Cancer Care Associates Medical Group
Redondo Beach, California, United States
Sansum Medical Research Foundation
Santa Barbara, California, United States
Central Coast Medical Oncology Corporation
Santa Monica, California, United States
Stanford University
Stanford, California, United States
SMO Pharmatech Oncology Inc
Denver, Colorado, United States
St Mary's Hospital Regional Cancer Center
Grand Junction, Colorado, United States
...and 56 more locations
Time frame: From Start of Treatment to Objective Progression or Start of New Anticancer Therapy (Up to 16 Weeks)
Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, emotional, cognitive, or social functioning), global health status and symptom scales of fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, or financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.
Time frame: Baseline, 2 Weeks
Pharmacokinetics (PK): Apparent Clearance of Abemaciclib
Abemaciclib apparent clearance (CL/F) was calculated by population nonlinear mixed effects modeling (NONMEM) using all available data spanning cycles 1 and cycles 3-5.
Time frame: Cycle(C)1, Day(D)1: 2 to 4 Hours (Hrs) Postdose; C1D14: 4 Hrs Postdose, 7 Hrs Postdose; C3D1: Predose, 3 Hrs Postdose, C4D1 & C5D1, Predose, C5D28: Predose, 3 Hrs Postdose
PK: Apparent Volume of Distribution of Abemaciclib
Abemaciclib apparent volume of distribution was calculated by population NONMEM using all available data spanning cycles 1 and cycles 3-5.
Time frame: Cycle(C)1, Day(D)1: 2 to 4 Hours (Hrs) Postdose; C1D14: 4 Hrs Postdose, 7 Hrs Postdose; C3D1: Predose, 3 Hrs Postdose, C4D1 & C5D1, Predose, C5D28: Predose, 3 Hrs Postdose