HER2 Status in Breast CancerHER2NCT07758127
Updates and Insights on HER2 in Breast Cancer in Sohag Governorate
An observational study of HER2 Status in Breast Cancer, run by Sohag University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 26 to 85 years, women only
- Conditions the study is for
- HER2 Status in Breast Cancer
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Cases with insufficient, destroyed, necrotic, or unavailable tissue blocks.
- Cases with incomplete clinical information.
- Cases lacking adequate immunohistochemical assessment.
- Cases outside the study period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr. Fatma El-Zahraa Prof. Dr. Fatma El-Zahraa Salah El-Deen Safe El-Deen, Professor of Pathology contact
Dr. Ola Dr. Ola Mohamed Nageeb Mazeed, Lecturer of Pathology contact
About this study
Official title: 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
Read the 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.
- Conditions
- HER2 Status in Breast Cancer
- Keywords
- HER2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
HER2 status in breast cancer
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.
Measured: 2025/2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 Status in Breast CancerStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Collaborators
- Sohag Oncology Center
- Responsible party
- Principal investigator, Rana Amgad Anwar, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758127
- Sponsor's protocol ID
- Soh-Med26-7-22MS
- Acronym
- HER2
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Updates and Insights on Human Epidermal Growth Factor Receptor 2 (HER2) in Breast Cancer in Sohag Governorate
- ClinicalTrials.gov ID
- NCT07758127
- Acronym / sponsor ID
- HER2 / Soh-Med26-7-22MS
- Conditions
- HER2 Status in Breast Cancer
- Keywords
- HER2
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Collaborators
- Sohag Oncology Center
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 26 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Cases with insufficient, destroyed, necrotic, or unavailable tissue blocks.
- Cases with incomplete clinical information.
- Cases lacking adequate immunohistochemical assessment.
- Cases outside the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Fatma El-Zahraa Prof. Dr. Fatma El-Zahraa Salah El-Deen Safe El-Deen, Professor of Pathology contact
Dr. Ola Dr. Ola Mohamed Nageeb Mazeed, Lecturer of Pathology contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2 Status in Breast Cancer, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Fatma El-Zahraa Prof. Dr. Fatma El-Zahraa Salah El-Deen Safe El-Deen, Professor of Pathology (01007970144, fatmafm2002@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HER2 status in breast cancer (time frame: 2025/2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.