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New PET scan agent aims to spot HER2 cancers more safely

NCT ID NCT04692831

Diagnosis Sponsor: Memorial Sloan Kettering Cancer Center 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This phase 1 trial tests whether a new radioactive imaging agent, 89Zr-ss-pertuzumab, is safe for detecting HER2-positive breast cancer in 60 participants. The agent is designed to bind to HER2 proteins on cancer cells and show up on PET/CT scans. The main goal is to check for side effects, not yet to measure how well it works.

What this could mean

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

Active substance
89Zr-ss-pertuzumab (a radioactive imaging agent)
What this could lead to
If successful, this could provide a safer and more precise way to detect HER2-positive cancers using PET/CT scans, helping guide treatment decisions.
What could go wrong
This is an early phase 1 trial focused on safety, not effectiveness. The imaging agent may not work as expected, 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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 60 people

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

Started

Nov 2020

Expected to finish

Nov 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: * Biopsy proven HER2-positive or HER2-low primary malignancy or metastatic disease Note: HER2 positivity is defined according to American Society of Clinical Oncology guidelines or ERBB2 amplification on next generation sequencing Note: HER2-low is defined as low HER2 expression, with immunohistochemistry (IHC) 1+ or IHC 2+ and in situ hybridization \[ISH\]-negative, including FISH. * Biopsy proven primary malignancy or metastatic disease * At least one malignant lesion on CT, MR, or FDG PET/CT within 60 days of protocol enrollment * Age 18 years or greater * ECOG performance of 0-2 Exclusion Criteria: * Creatinine \> 2 times normal limit (obtained with 8 weeks of enrollment) * AST/ALT \> 2 times normal limit (obtained with 8 weeks of enrollment) * Life expectancy \< 3 months * Pregnancy or lactation * Patients who cannot undergo PET/CT due to weight limits (over 450 pounds)

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Conditions

The condition(s) this trial relates to.

HER2 positive breast carcinoma

As listed by the trial registrant

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

HER-2 positive malignant carcinoma of breast HER-2 protein overexpression HER2-positive metastatic breast cancer

Contacts and locations

Locations

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Monmouth (Limited protocol activities)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (Limited Protocol Activites)

    Rockville Centre, New York, 11553, United States

  • Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604, United States

  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920, United States

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