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RECRUITINGNCT06551116

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

This study will assess whether a quantitative, HER2 assay can accurately and reliably discriminate between responders and non-responders among patients with HER2 IHCI+ metastatic breast cancer who are...

Lead sponsor: Abramson Cancer Center at Penn Medicine•36 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Angela DeMichele, MD

CONTACT

215-908-2599 angela.demichele@pennmedicine.upenn.edu

Sponsors

Lead Sponsor

Abramson Cancer Center at Penn Medicine

Collaborators

Translational Breast Cancer Research Consortium
Danaher Inc.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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.

Exclusion Criteria

•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
•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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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 5, 2025Terms

Trial snapshot

StatusRECRUITING

Phase—

Enrollment200

Start dateOct 2024

Last updatedSep 5, 2025

Condition

HER2-positive Metastatic Breast Cancer

Locations shown

University of California San Francisco Medical Center

San Francisco, California

Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut

Smilow Cancer Hospital Care Center

Fairfield, Connecticut

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2025Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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