Clinical Trial

PI3K Pathway Activation Markers in ER-Positive, HER2-Negative Breast Cancer: A Clinicopathologic Study

Study acronym: p-AKT p-S6
Not Yet Recruiting
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Summary
The goal of this observational study is to examine whether markers of PI3K pathway activation are associated with endocrine therapy response and clinicopathologic features in estrogen receptor-positive, HER2-negative breast cancer. The main questions it aims to answer are: Are immunohistochemical levels of phosphorylated AKT (p-AKT) and phosphorylated S6 (p-S6) different between endocrine-sensitive and endocrine-resistant breast cancer cases? Do different levels of p-AKT and p-S6 show distinct clinicopathologic and histologic characteristics, including features of the tumor microenvironment? Archived tumor tissue from patients who received adjuvant endocrine therapy as part of routine clinical care will be analyzed. Biomarker expression will be correlated with clinicopathologic parameters, including tumor-infiltrating lymphocyte density, tumor budding, and other histologic features, to explore associations with tumor behavior and outcomes.
Trial Details
NCT Number NCT07387861
Lead Sponsor Assiut University
Conditions Breast Cancer - ER+, HER2-, PIK3CA Gene Mutation
Enrollment 70 participants
Start Date 2026-03
Primary Completion 2028-01 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-02-04