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Can a better HER2 test predict who responds to targeted therapy?

NCT ID NCT06551116

Diagnosis Sponsor: Abramson Cancer Center at Penn Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 09, 2026 · Updated 3 times

Summary

This study is testing a new, more precise method to measure HER2 levels in leftover tumor tissue from people with HER2-low metastatic breast cancer. The goal is to see if this test can accurately tell who will respond to the drug T-Dxd. Researchers will enroll 200 participants and compare the test results with actual treatment outcomes.

What this could mean

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

Active substance
quantitative HER2 assay (diagnostic test on leftover tumor tissue)
What this could lead to
If successful, this could lead to a more accurate test that helps doctors identify which patients with HER2-low breast cancer will benefit from targeted therapy like T-Dxd.
What could go wrong
This is an early diagnostic study, not a treatment trial. The test may not reliably predict response, and results may not change patient outcomes.

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 200 people

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

Started

Oct 2024

Expected to finish

Sep 2029

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.

Who is studied

Patients with HER2 IHC1+ metastatic breast cancer, histologically confirmed

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: * Women and men age \> 18 years * Metastatic breast cancer, histologically- confirmed. Any estrogen receptor (ER) status is allowed. ER status will be determined by local laboratory assessment utilizing ASCO/CAP guidelines. * Primary and/or metastatic tumor with 1+ level of expression of HER2 by immunohistochemistry as determined by local laboratory assessment utilizing ASCO/CAP guidelines. * Measurable disease by cross-sectional imaging at the start of treatment. Patients with measurable bone-only disease or active brain metastases are eligible. * Archival tissue available for biomarker assessment. One specimen should be the most recent metastatic biopsy. If HER2 1+ status was determined on a different specimen (either primary or metastatic tissue), that specimen is also required. Samples obtained from bone metastases that were processed via decalcification methods are not eligible. * Intention to initiate therapy with T-DXd (Enhertu) at FDA-approved dose and schedule as next line of therapy. If T-DXd was already initiated, patients must be registered within 30 days of initiation. * Ability to provide informed consent Exclusion Criteria: * Concurrent Her2-overexpressing metastatic breast cancer (as confirmed by a metastatic biopsy with IHC 3+ or IHC 2+ with FISH amplified as per standard ASCO/CAP guidelines)

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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.

HER2-positive metastatic breast cancer

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    37 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Abramson Cancer Center of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

    Contact Email: •••••@•••••

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    RECRUITING

    Houston, Texas, 77054, United States

  • Ben Taub General Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Georgetown University - Lombardi CCC

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • John's Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77079, United States

  • MD Anderson Cancer Center

    RECRUITING

    Sugar Land, Texas, 77478, United States

  • MD Anderson Cancer center

    RECRUITING

    Houston, Texas, 77030, United States

  • MD Anderson Cancer center

    RECRUITING

    League City, Texas, 77573, United States

  • MD Anderson Cancer center

    RECRUITING

    Woodland, Texas, 77384, United States

  • MedStar Washington Hospital Center

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Montefiore Einstein Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • Penn Medicine Princeton Medical Center

    RECRUITING

    Plainsboro, New Jersey, 08536, United States

  • Sibley Memorial Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20016, United States

  • Smilow Cancer Hospital Care Center

    RECRUITING

    Fairfield, Connecticut, 06824, United States

  • Smilow Cancer Hospital Care Center

    RECRUITING

    Guilford, Connecticut, 06437, United States

  • Smilow Cancer Hospital Care Center

    RECRUITING

    Trumbull, Connecticut, 06611, United States

  • Smilow Cancer Hospital Care Center

    RECRUITING

    Westerly, Rhode Island, 02891, United States

  • Smilow Cancer Hospital Care Center - Waterford

    RECRUITING

    Waterford, Connecticut, 06385, United States

  • Smilow Cancer Hospital Care Center at Greenwich

    RECRUITING

    Greenwich, Connecticut, 06830, United States

  • Smilow Cancer Hospital Care Center at Long Ridge

    RECRUITING

    Stamford, Connecticut, 06901, United States

  • Smilow Cancer Hospital at Glastonbury

    RECRUITING

    Glastonbury, Connecticut, 06033, United States

  • Smilow Cancer Hospital at Saint Francis

    RECRUITING

    Hartford, Connecticut, 06105, United States

  • Smilow Cancer Hospital-Derby Care Center

    RECRUITING

    Derby, Connecticut, 06418, United States

  • Smilow Cancer Hospital-Torrington Care Center

    RECRUITING

    Torrington, Connecticut, 06790, United States

  • Smilow Cancer Hospital-Waterbury Care Center

    RECRUITING

    Waterbury, Connecticut, 06708, United States

  • UNC Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • UPMC Hillman CC

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of California San Francisco Medical Center

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Chicago Comprehensive Cancer Center at Silver Cross

    RECRUITING

    New Lenox, Illinois, 60451, United States

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Chicago Medicine Northwest Indiana

    RECRUITING

    Crown Point, Indiana, 46307, United States

  • University of Chicago Medicine-Orland Park

    RECRUITING

    Orland Park, Illinois, 60462, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Washington - Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06511, United States

  • Yale-New Haven Hospital North Haven Medical Center

    RECRUITING

    New Haven, Connecticut, 06473, United States

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