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New scan could predict which brain tumors will shrink

NCT ID NCT05376878

Diagnosis Sponsor: City of Hope Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Updated 2 times

Summary

This pilot study tests a special PET/MRI scan that uses a radioactive tracer to find HER2+ breast cancer that has spread to the brain. The scan aims to show whether the cancer cells take up the tracer, which might predict if they will respond to the standard drug trastuzumab deruxtecan. Ten women with HER2+ breast cancer and brain metastases will be scanned before starting treatment. The goal is to see if the scan can help guide therapy.

What this could mean

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

Active substance
64Cu-DOTA-Trastuzumab (a radioactive tracer for imaging)
What this could lead to
If successful, this scan could help doctors see which brain metastases will respond to trastuzumab deruxtecan, guiding personalized treatment.
What could go wrong
This is a very small pilot study (10 people) focused on imaging, not treatment. The scan may not reliably predict outcomes, and results may not apply to all 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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 10 people

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

Started

Dec 2022

Expected to finish

Apr 2027

An estimate. End dates often move.

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.

Ages

18 years and older

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: * Documented informed consent of the participant and/or legally authorized representative * Women with documented metastatic HER2 positive breast cancer (American Society of Clinical Oncology \[ASCO\] College of American Pathologist \[CAP\] guidelines) who have brain metastases * Age \> 18 years * Eastern Cooperative Oncology Group (ECOG) 0-2 * Patients with leptomeningeal disease will be considered eligible * Planned therapy with fam-trastuzumab deruxtecan * Left ventricular ejection fraction (LVEF) \> 50% * Absolute neutrophil count (ANC) \> 1.5 x 10\^9/L * Platelets \> 100 x 10\^9/L * Hemoglobin \> 9 g/dL * Total (T.) bilirubin \< 3 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5 x ULN * Creatinine clearance \> 30 ml/min (by Cockcroft-Gault formula) * Activated partial thromboplastin time (aPTT) \< 1.5 x ULN * Prior therapy for central nervous system (CNS) disease is allowed, but at least 1 lesion \> 1.5 cm is evident on MRI Exclusion Criteria: * Need for immediate local intervention for brain metastases * Noninfectious interstitial lung disease or pneumonitis requiring glucocorticoids * Clinically significant corneal disease * Myocardial infarction \< 6 months before, congestive heart failure (CHF), unstable angina, or serious cardiac arrhythmia

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Conditions

The condition(s) this trial relates to.

brain cancer breast cancer breast carcinoma breast neoplasm HER2 positive breast carcinoma metastatic malignant neoplasm in the brain

As listed by the trial registrant

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

Anatomic stage IV breast cancer ajcc V8 Metastatic breast carcinoma Metastatic malignant neoplasm in the brain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. 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

  • City of Hope Medical Center

    RECRUITING

    Duarte, California, 91010, United States

More trials for these conditions

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