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Clinical Trials/NCT07758127
NCT07758127Not yet recruitingNot Applicable

Updates and Insights on Human Epidermal Growth Factor Receptor 2 (HER2) in Breast Cancer in Sohag Governorate

Sohag University1 site in 1 country100 target enrollmentStarted: September 1, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rana Amgad Anwar

Pathology resident at Sohag Oncology Center

Sohag University

Study Sites (1)

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