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Egyptian study reveals hidden breast cancer subtype

NCT ID NCT06188494

Knowledge-focused Sponsor: AstraZeneca 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study reviewed medical records of 405 people in Egypt with advanced HER2-negative breast cancer to find out how many actually have a subtype called HER2-low. Researchers looked at past test results to estimate the prevalence. The goal is to better understand who might be eligible for newer treatments targeting HER2-low cancers.

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
If successful, this study could help doctors better identify patients who might benefit from newer targeted therapies for HER2-low breast cancer.
What could go wrong
This is an observational study that only looks back at existing data, so it cannot prove any treatment works. The results may not apply to other populations or testing methods.

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

405 people

The number who actually took part.

Started

May 2024

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Patients with confirmed diagnosis of HER2-negative, unresectable and/or mBC (regardless of HR status) between 01 January 2017 and 31 December 2020 who progressed on any systematic anticancer therapy (eg, ET, chemotherapy, CDK4/6i, targeted therapies other than anti-HER2, or immunotherapy). Patients' clinical outcomes will be followed up for 2 years after the date of their diagnosis.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

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: 1. Men or women ≥ 18 years of age, 2. Must have a histological, cytological, or radiological confirmed diagnosis of unresectable or/and mBC between 01 January 2017 and 31 December 2020, with at least 2 years of follow-up data unless patient's death is confirmed, 3. Diagnosed as HER2-neg (HER2 IHC 0, 1+, 2+/ISH-), regardless of hormone status, 4. Must have a report in her file with HER2 scoring with IHC/ISH or both, 5. Progressed on any systemic anti-cancer therapy (eg, ET, chemotherapy, CDK4/6i, targeted therapies other than anti-HER2, or immunotherapy) in the metastatic setting. 6. Due to the retrospective nature of the study a waiver grant of the consent will be requested from the IRB/IEC for the study participants, if waiver not granted Patient or next of kin/legal representative (for deceased patients at study entry) willing and able to provide written informed consent according to the local regulations. Exclusion Criteria: * Records of patients who meet any of the following criteria will be excluded: 1. History of other malignancies than mBC, 2. Historical HER2 status of IHC 2+/ISH+ or 3+, or HER2 amplified.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Her2-receptor negative breast cancer

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • Research Site

    Alexandria, Egypt

  • Research Site

    Asyut, Egypt

  • Research Site

    Cairo, Egypt

  • Research Site

    Gharbia, Egypt

  • Research Site

    Giza, Egypt

  • Research Site

    Luxor, Egypt

  • Research Site

    Sohag, Egypt

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