NCT07387861Not yet recruiting
PI3K Pathway Activation Markers in ER-Positive, HER2-Negative Breast Cancer: A Clinicopathologic Study
Immunohistochemical Evaluation of p-AKT and p-S6 as Surrogate Markers of PI3K/AKT/mTOR Pathway Activation in ER-Positive, HER2-Negative Breast Carcinoma
Source: ClinicalTrials.gov · Last updated 4 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 70 (estimated)
- First submitted
- 25 Jan 2026
- Start date
- Mar 2026
- Primary completion date
- Jan 2028
- Lead sponsor
- Assiut University
- Diseases
- Childhood cancers
- NCT number
- NCT07387861
What you commit to
- Study type: Observational
- Planned participants: 70
- From Mar 2026 to the primary completion date, Jan 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Cases with missing or unavailable FFPE tissue blocks.
- Cases with insufficient tissue quality for immunohistochemistry (e.g., severely degraded or exhausted FFPE block).
- Cases with unknown or incomplete follow-up or treatment data.
Who the study is looking for
- Patients diagnosed with invasive breast carcinoma.
- ER-positive and HER2-negative tumor status.
- Received adjuvant endocrine therapy as part of routine clinical care.
- Archived formalin-fixed paraffin-embedded (FFPE) tumor tissue available from excisional specimens (mastectomy).
- Available medical records documenting treatment history and follow-up outcomes.
Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.