Clinical Trial Search

Primary: Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration. — -2.3 Change in % of cells positive for Ki-67

Primary: Change in Proliferation Rate (Ki-67 by Immunocytochemistry) From Baseline to 6 Months — -1.5; -1.1 percentage of cells stained positive — p=0.92

Primary: Percent Change in Mammographic Density at 1 Year on Exemestane — -2.4 percent change from baseline

Primary: Number of Participants With a Change in Ki-67 Level — 15; 5; 3 Participants — p=0.004

Primary: Number of Participants With and Without Progression Free Survival (PFS) Events — 92; 30 Participants

Primary: Overall Response Rate as Measured by Clinical Exam, Standard Imaging, and Surgical Pathology Findings — 23; 0 Participants

Primary: Percentage of Women With Serious Adverse Events — 0.0 percentage of women

Primary: Clinical Benefit Rate (CR + PR + SD > 6 Months). — 7.1; 6.3 Percent of Participants

Primary: Progression-free Survival (PFS) — 14.4; 19.3 Months

Primary: Measure Ki67 Index in Highly Hormone-dependent Breast Cancers vs. Those That Are Not — 7; 6; 40 Participants

Primary: Change in Ki-67 Levels From Baseline (Pre) to Day 28 (Post) Biopsy Samples — -1.3632; -1.6237 log-transformed Ki67% — p=0.6202

Primary: Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades — 4; 0; 4; 195 Participants

Primary: Disease-free Survival (DFS) — 87.5; 85.8 percentage of patients — p=.31

Primary: Relative Change of ≥ 5% in Breast Density at 6 Months — 13; 8; 4 Participants — p=0.026

Primary: BMD of Spine by DXA — 2.269; -1.735 percentage change

Primary: Number of Participants With Treatment-Emergent Adverse Events (All Causalities) — 92; 152; 244; 18 Participants

Primary: Objective Response Rate (ORR) Determined by Clinical Palpation — 58.9; 53.8 percentage of participants

Primary: Disease-free Survival — 64; 71; 70 percentage of participants

Primary: Event-free Survival — 88; 89 percentage of participants — p=0.85

Primary: Change in Bone Mineral Density (BMD) From Baseline to 1 Year — 0.048; 0.007; 0.014; 0.005 grams per cubic centimeter

Primary: Progression-free Survival (PFS) Rate at 3 Months — 50.1 percent of participants

Primary: Tolerability at One Year of Ovarian Function Suppression (OFS) Using Leuprolide and Letrozole. — 4 participants

Primary: Change in Breast Density at 6 Months — -5.45; -13.71 cm^3

Primary: Overall Survival — 2.14; 2.00 years

Primary: Progression-free Survival — 4.3 months

Primary: Overall Response Rate (ORR) — 40.7; 5.0; 8.8 percentage

Primary: Change in Lumbar Density From Baseline to 12 Months — -0.036; -0.021 g/cm^2 — p=0.15

Primary: Change in Background Parenchymal Uptake (BPU) on Molecular Breast Imaging (MBI) — 0.0; -12 percent change in BPU

Primary: Number of Participants With Grade 4 Toxicity

Primary: Mammographic Breast Density Using Cumulus Software — -6.30; -5.77; -2.81; -5.43 Percent Change in Breast Density