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New study tracks Real-World success of breast cancer drug in GCC

NCT ID NCT07597993

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times

Summary

This study will follow about 109 women in Gulf Cooperation Council (GCC) countries who have a certain type of advanced breast cancer (HR-positive, HER2-low or ultra-low) and are taking the drug trastuzumab deruxtecan after hormone therapy stopped working. Researchers want to see how long the drug controls the cancer and what side effects occur in everyday medical practice, not just in a controlled trial. The goal is to learn how to best use this treatment in the 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

About 109 people

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

Started

Jul 2026

Expected to finish

Mar 2029

An estimate. End dates often move.

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

The study population will consist of adult (age ≥ 18 years old at the date of T-DXd initiation) female patients with a confirmed diagnosis of HR-positive, HER2-low (defined as immunohistochemistry \[IHC\] 1+ or IHC 2+/In situ hybridization \[ISH\]-) or HER2-ultralow (IHC 0 with membrane staining) mBC that has progressed on one or more ET in the metastatic setting and initiated T-DXd up to 30 days before the index date.

Ages

18 years and older

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: * -Female patients aged ≥18 years old at the time of T-DXd initiation * Patients with a confirmed histological or cytologically based diagnosis of HR-positive mBC. * Patients who were classified as HER2-low or HER2-ultralow mBC confirmed by the closest locally obtained HER2 test prior to or on the index date, and who meet the following definitions: * HER2-low status defined as IHC scores 1+ and 2+ without ISH gene amplification based on the pathology report. * HER2-ultralow status defined as IHC 0 with membrane staining based on the pathology report. * Patient who received at least one prior line of ET (± targeted therapy) in the metastatic setting. * Patients who are chemotherapy-naïve in the metastatic setting. * Patients who initiated T-DXd up to 30 days before the signature of the ICF. The decision to initiate T-DXd must be made independently by treating physicians as part of routine clinical practice. * Patients are willing to sign the written ICF, indicating that they understand the purpose of the study and procedures required for participation. Exclusion Criteria: * -Patients with a history of other malignancies, other than basal cell carcinoma of the skin and squamous cell carcinoma of the skin. * Patients who received prior chemotherapy in the metastatic setting. * Patients with Eastern Cooperative Oncology Group (ECOG) status ≥2 or missing ECOG status at the time of initiation of T-DXd (index date). * Patients with a history of participation in another clinical trial in the metastatic setting. * Female patient with current or planned pregnancy, or breastfeeding.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

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

    9 sites in 4 countries. 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

  • Research Site

    NOT_YET_RECRUITING

    Muscat, Oman

  • Research Site

    NOT_YET_RECRUITING

    Doha, Qatar

  • Research Site

    NOT_YET_RECRUITING

    Mecca, Mecca Region, Saudi Arabia

  • Research Site

    NOT_YET_RECRUITING

    Jeddah, Saudi Arabia

  • Research Site

    RECRUITING

    Riyadh, Saudi Arabia

  • Research Site

    NOT_YET_RECRUITING

    Riyadh, Saudi Arabia

  • Research Site

    NOT_YET_RECRUITING

    Abu Dhabi, United Arab Emirates

  • Research Site

    NOT_YET_RECRUITING

    Al Ain City, United Arab Emirates

  • Research Site

    NOT_YET_RECRUITING

    Dubai, United Arab Emirates

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