Can a targeted drug tame advanced HER2-Positive breast cancer?

NCT ID NCT07778407

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This study looks at how well trastuzumab deruxtecan (T-DXd) works and how safe it is in women with HER2-positive metastatic breast cancer. The drug is given as an intravenous infusion every three weeks to patients who have already tried other anti-HER2 treatments. Researchers will track how long the cancer stays controlled, overall survival, and any side effects. The goal is to see if this treatment offers a real-world benefit for this group of patients.

What this could mean

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

Active substance
trastuzumab deruxtecan (T-DXd), an antibody-drug conjugate given intravenously every 3 weeks
What this could lead to
If successful, this could provide real-world evidence supporting the use of trastuzumab deruxtecan as a standard treatment for metastatic HER2-positive breast cancer, potentially improving outcomes for patients who have progressed on prior therapies.
What could go wrong
This is a small, single-center study, so results may not apply broadly. The drug can cause serious side effects, including lung toxicity, and its effectiveness may vary among patients.

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

25 people

The number who actually took part.

Started

Feb 2023

Finished

May 2026

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

metastatic Her2 positive breast cancer

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 * Histologically confirmed HER2-positive metastatic breast cancer * Progression during or within 6 months of finishing adjuvant anti-HER2 therapy (T-DXd as 2nd line), OR de novo metastatic disease previously treated with ≥ 2 lines of anti-HER2 therapy (T-DXd as 3rd line or beyond) * ECOG Performance Status 0-1 * LVEF ≥ 50% on echocardiography * Measurable lesions per RECIST v1.1 * Adequate hematologic, hepatic, and renal function Exclusion Criteria: * History of non-infectious interstitial lung disease (ILD) / pneumonitis requiring steroids * Active uncontrolled infection * Symptomatic/uncontrolled brain metastases * Severe cardiac dysfunction (LVEF \< 50%) * Pregnancy or lactation

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Breast advanced malignancies are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • King Salman Bin Abdulaziz Medical City (KSAMC) - Oncology Center

    Madinah, Saudi Arabia

More trials for these conditions

Other studies related to the condition(s) this trial covers.