Can a targeted drug tame advanced HER2-Positive breast cancer?
NCT ID NCT07778407
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
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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 Hide 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
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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
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