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New study maps hidden breast cancer subtype in gulf women

NCT ID NCT06125314

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked back at medical records of 517 women in Gulf countries with advanced breast cancer that was previously labeled HER2-negative. Researchers re-tested old tumor samples to find out how many actually have HER2-low breast cancer, a newer subtype. The goal is to better understand how common it is and how it behaves, which could improve future diagnosis and 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
If successful, this study could help doctors better identify and understand HER2-low breast cancer, potentially leading to more personalized treatment approaches in the future.
What could go wrong
This is a retrospective chart review, not a treatment trial, so it cannot prove any new therapy works. The results may not apply outside the Gulf region.

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

517 people

The number who actually took part.

Started

Mar 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

Adult (aged \> 18 years old) patients with a confirmed diagnosis of HER2-negative (assessed preferably by Ventana 4b5 assay) Unresectable and/or mBC who presented to the participating centers within the period from 1st January 2018 to 31st December 2022 and who are diagnosed and/or progressed on at least one prior systemic anti-cancer therapy (Endocrine therapy, chemotherapy, CDK4/6i, targeted therapies other than anti-HER2, or PDL1 inhibitor) , regardless of their hormonal status.

Ages

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

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: * women ≥ 18 years of age at date of diagnosis * Patients must have a histological or cytological confirmed diagnosis of Unresectable or/and mBC between 01st January 2018 and 31st December 2022. * Patients with at least 12 months of follow-up data (from the index date) in the medical records at the participating site unless patient died. * Patients must have been diagnosed as HER2-negative (HER2 IHC 0, 1+, 2+/ISH-), regardless of hormone status. * Patients who are diagnosed and/or progressed on at least one prior systemic anticancer therapy (e.g., ET, chemotherapy, CDK4/6i, targeted therapies other than anti- HER2, or immunotherapy) in the metastatic setting. * Patients must have historical HER2 fixed tissue IHC stained slides in acceptable quality to allow retesting of HER2 expression only in case of the absence of accurate scoring of IHC/ISH in pathology report. Exclusion Criteria: * Have a history of other malignancies other than basal cell carcinoma of the skin and squamous cell carcinoma of the skin. * Patients who are HER2 positive (with 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 carcinoma breast neoplasm

As listed by the trial registrant

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

Breast cancer Breast carcinoma Breast neoplasms GENES HER2

Contacts and locations

Locations

  • Research Site

    Kuwait City, Kuwait

  • Research Site

    Doha, Qatar

  • Research Site

    Mecca, Saudi Arabia, Saudi Arabia

  • Research Site

    Riyadh, Saudi Arabia

  • Research Site

    Abu Dhabi, United Arab Emirates

  • Research Site

    Al Ain City, United Arab Emirates

  • Research Site

    Dubai, United Arab Emirates

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