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Can better HER2 classification improve breast cancer care?

NCT ID NCT07758127

Knowledge-focused Sponsor: Sohag University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This study looks at breast cancer tumors to understand HER2 levels, including low and ultra-low expressions, which may affect treatment choices. Researchers will examine tissue samples from 100 patients diagnosed in Sohag, Egypt, and compare HER2 status with other tumor features like grade and lymph node involvement. The goal is to improve how HER2 is scored and interpreted, potentially leading to more personalized care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
This could lead to more precise classification of breast cancer subtypes, helping doctors tailor treatments more effectively.
What could go wrong
This is an observational study, so it won't directly test a treatment. Results may not apply beyond the local population.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

26 to 85 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HER2 status in breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Faculty of medicine sohag university

    Sohag, Egypt

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