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QuantifyHER: HER2 Testing in Metastatic Breast Cancer

This study is looking at how well a special test, called CE-10-IVD, can identify patients with HER2-low metastatic breast cancer who will respond to treatment with T-DXd. You might be able to join if you are over 18, have metastatic breast cancer, and your tumor shows a specific level of HER2 (1+ by immunohistochemistry). Researchers will analyze leftover tumor tissue from a routine biopsy. The main goal is to see if this test can accurately tell who will respond to T-DXd, measured by how well the treatment works (Objective Response Rate) over a long period, up to 100 months. The current recruitment status for this study is unclear.

Study design
This is an observational study planning to enroll 200 participants. It is not a randomized study.
What's involved
Leftover tumor tissue from a routine biopsy will be sent for analysis. The study does not specify other visits or procedures.
Compensation
Not stated in the trial record.
Follow-up
Your response to T-DXd will be measured from the date of your first dose to your last dose, for up to 100 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06551116

QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer

Recruiting
Not specifiedAges 18+Observational
Abramson Cancer Center at Penn Medicine
~200 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:CE-10-IVD

At a glance

Recruiting sites
37 of 37 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Real-World Objective Response Rate
Measured over from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months

Conditions

HER2-positive Metastatic Breast Cancer

Explore related trials

Breast CarcinomaERBB2 Gene

Where it's being run

37 sites across 13 states
Connecticut13
Texas7
District of Columbia3
Illinois3
Pennsylvania3
California1
Indiana1
Maryland1

Study leadership

  • Angela DeMichele, MD · PRINCIPAL_INVESTIGATOR · Abramson Cancer Center at Penn Medicine

Who to contact

Angela DeMichele, MD
[email protected]
215-908-2599
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Real-World Objective Response Ratefrom date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months

    Association between quantitative HER2 expression (as a continuous variable) and real-world objective response rate