Updates and Insights on HER2 in Breast Cancer in Sohag Governorate (HER2)

August 10, 2026 updated by: Rana Amgad Anwar, Sohag University

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

  • 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

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dr. Fatma El-Zahraa Prof. Dr. Fatma El-Zahraa Salah El-Deen Safe El-Deen, Professor of Pathology
  • Phone Number: 01007970144
  • Email: fatmafm2002@yahoo.com

Study Contact Backup

Study Locations

  • Egypt
      • Sohag, Egypt
        • Faculty of Medicine Sohag University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population includes female patients with histopathologically confirmed breast cancer diagnosed at Sohag Oncology center during the study period (2025-2026). Archived formalin-fixed paraffin-embedded tissue blocks and corresponding pathology records will be retrospectively reviewed to evaluate HER2 status. Only cases meeting the eligibility criteria will be included.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2025/2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Collaborators

Sohag Oncology Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

August 5, 2026

First Submitted That Met QC Criteria

August 5, 2026

First Posted (Actual)

August 11, 2026

Study Record Updates

Last Update Posted (Actual)

August 12, 2026

Last Update Submitted That Met QC Criteria

August 10, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Soh-Med26-7-22MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe