Updates and Insights on Human Epidermal Growth Factor Receptor 2 (HER2) in Breast Cancer in Sohag Governorate
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Sohag University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- HER2 status in breast cancer
Study Overview
Brief Summary
- To evaluate HER2 expression in breast carcinoma with emphasizing HER2-ultralow, and HER2-low, HER2 equivocal tumors.
- To correlate the results of HER2 with clinico-pathological prognostic parameters; examples tumor grade, Ki-67 proliferation index, nodal status, tumor size, lympho-vascular invasion, and perineural invasion, tumor infiltrating lymphocytes
- To access interobserval agreement in HER2 score interpretation
Detailed Description
HER2 status is no longer simply classified as a positive or negative. It is now evaluated on a score from 0 to 3+, where score 3+ indicates HER2-positive disease because it shows strong, complete circumferential membranous staining. In the HER2-negative spectrum, score 1+ and score 2+ without gene amplification are classified as HER2-low, while score 0 involves both HER2-null cases with no membrane staining and HER2-ultralow cases with faint or weak incomplete membranous staining in ≤10%, of tumor cells. In addition, ISH can be used to determine HER2 gene amplification status. The emergence of HER2-low and also HER2-ultralow concepts has challenged the traditional binary framework and increased the need for collective reporting. As a result, careful interpretation of delicate staining patterns, reproducible scoring and appropriate use of complementary testing methods are now central to accurate HER2 classification in both primary and metastatic breast cancer.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 26 Years to 85 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Breast cancer cases diagnosed during 2025 and
- •Cases with available HER2 immunohistochemical results.
- •Cases with sufficient tissue material for evaluation.
- •Cases with complete clinical and follow-up data.
- •Cases that were accessible for pathologic review
Exclusion Criteria
- •Cases with insufficient, destroyed, necrotic, or unavailable tissue blocks.
- •Cases with incomplete clinical information.
- •Cases lacking adequate immunohistochemical assessment.
- •Cases outside the study period
Arms & Interventions
Breast cancer female patients
Female patients with histopathologically confirmed breast cancer diagnosed at Sohag Oncology center during 2025-2026. Archived formalin-fixed paraffin-embedded tissue samples and pathology records will be retrospectively reviewed to evaluate HER2 status by immunohistochemistry (IHC)
Outcomes
Primary Outcomes
HER2 status in breast cancer
Time Frame: 2025/2026
To evaluate the HER2 status among breast cancer patients diagnosed at Sohag Oncology center using immunohistochemistry (IHC) and, when indicated, in situ hybridization (ISH), and to describe the distribution of HER2 expression.
Secondary Outcomes
No secondary outcomes reported
Investigators
Rana Amgad Anwar
Pathology resident at Sohag Oncology Center
Sohag University
