HER2 Status in Breast Cancer
Conditions
Keywords
HER2
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.
Interventions
None listed
Sponsors
Sohag University
Sohag Oncology Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
26 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Breast cancer cases diagnosed during 2025 and 2026. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HER2 status in breast cancer | 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. |
Countries
Egypt
Contacts
CONTACTDr. Fatma El-Zahraa Prof. Dr. Fatma El-Zahraa Salah El-Deen Safe El-Deen, Professor of Pathology
CONTACTDr. Ola Dr. Ola Mohamed Nageeb Mazeed, Lecturer of Pathology
Outcome results
None listed