The purpose for this study is to see if the study drug, LY3484356, is safe and to determine what effects it has on breast cancer in participants with Estrogen Receptor Positive (ER+), HER2 Negative (HER2-) early stage (stage I-III) breast cancer, when given prior to surgery. Participation in this study could last up to 2.5 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
87
Administered orally.
Winship Cancer Center Emory University
Atlanta, Georgia, United States
Northwestern Memorial Hosptial
Chicago, Illinois, United States
Percent Change From Baseline in Estrogen Receptor (ER) Expression
Tumor tissue collected by biopsy is used to determine ER expression. ER expression is measured by immunohistochemistry (IHC) and quantified by H-score. The H-score was calculated as the sum of multiplying the tumor cell ER staining intensity level 0 to 3 (0=none, 1=low, 2=moderate, 3=high) by the percentage (0 to 100) of cells at each intensity. Total ER H-score ranged from 0 to 300, where a higher score indicated stronger ER expression. Percent change in ER expression was defined as 100\*(ER expression on-treatment - ER expression pre-treatment)/(ER expression pre-treatment). Geometric mean percent change and 90 percent (%) confidence interval for percent change were obtained from a t-test of the log ratio i.e. log(ER expression on-treatment/ER expression pre-treatment).
Time frame: Baseline, Day 15
Percent Change From Baseline in Ki-67
Tumor tissue collected by biopsy is used to determine Ki-67 expression. It is measured by IHC and the Ki-67 index is defined as the percent of cells staining positive by validated central assay. Percent change in Ki-67 index was defined as 100\*(Ki-67 index on-treatment - Ki-67 index pre-treatment)/(Ki-67 index pre-treatment). Geometric mean percent change and 90 percent (%) confidence interval for percent change were obtained from a t-test of the log ratio i.e. log(Ki-67 index on-treatment/Ki-67 index pre-treatment).
Time frame: Baseline, Day 15
Percent Change From Baseline in Progesterone Receptor (PR) Expression
Tumor tissue collected by biopsy is used to determine PR expression. PR expression is measured by IHC and quantified by H-score. The H-score was calculated as the sum of multiplying the tumor cell ER staining intensity level 0 to 3 (0=none, 1=low, 2=moderate, 3=high) by the percentage (0 to 100) of cells at each intensity. Total PR H-score ranged from 0 to 300, where a higher score indicated stronger PR expression. Percent change in PR expression was defined as 100\*(PR expression on-treatment - PR expression pre-treatment)/(PR expression pre-treatment). Geometric mean percent change and 90 percent (%) confidence interval for percent change were obtained from a t-test of the log ratio i.e. log(PR expression on-treatment/PR expression pre-treatment).
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Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Institut Jules Bordet
Brussel - Capital, Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, Belgium
...and 9 more locations
Time frame: Baseline, Day 15
Pharmacokinetics (PK): Plasma Concentration of LY3484356
Plasma Concentration of LY3484356 evaluated using sparse sampling methodology
Time frame: Day 1: 3.5 hours (h) postdose; Day 8: Predose; Day 8: 3.5 h postdose