QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer
NCT ID: NCT06551116
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2024-10-10
2029-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HER2 Assay
Analysis of HER2 expression via QIF and mRNA assays
CE-10-IVD
Leftover tumor tissue from a routine biopsy will be sent for analysis.
Interventions
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CE-10-IVD
Leftover tumor tissue from a routine biopsy will be sent for analysis.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Translational Breast Cancer Research Consortium
OTHER
Danaher Inc.
UNKNOWN
Abramson Cancer Center at Penn Medicine
OTHER
Responsible Party
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Principal Investigators
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Angela DeMichele, MD
Role: PRINCIPAL_INVESTIGATOR
Abramson Cancer Center at Penn Medicine
Locations
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University of California San Francisco Medical Center
San Francisco, California, United States
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States
Smilow Cancer Hospital Care Center
Fairfield, Connecticut, United States
Smilow Cancer Hospital at Glastonbury
Glastonbury, Connecticut, United States
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, United States
Smilow Cancer Hospital Care Center
Guilford, Connecticut, United States
Smilow Cancer Hospital at Saint Francis
Hartford, Connecticut, United States
Yale-New Haven Hospital North Haven Medical Center
New Haven, Connecticut, United States
Yale Cancer Center
New Haven, Connecticut, United States
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, United States
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, United States
Smilow Cancer Hospital Care Center
Trumbull, Connecticut, United States
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, United States
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, United States
Georgetown University - Lombardi CCC
Washington D.C., District of Columbia, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States
University of Chicago Medicine Northwest Indiana
Crown Point, Indiana, United States
John's Hopkins Hospital
Baltimore, Maryland, United States
Montefiore Einstein Medical Center
The Bronx, New York, United States
UNC Chapel Hill
Chapel Hill, North Carolina, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
UPMC Hillman CC
Pittsburgh, Pennsylvania, United States
Smilow Cancer Hospital Care Center
Westerly, Rhode Island, United States
Ben Taub General Hospital
Houston, Texas, United States
MD Anderson Cancer center
Houston, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
MD Anderson Cancer center
League City, Texas, United States
MD Anderson Cancer Center
Sugar Land, Texas, United States
MD Anderson Cancer center
Woodland, Texas, United States
University of Washington - Fred Hutchinson Cancer Center
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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855924
Identifier Type: OTHER
Identifier Source: secondary_id
UPCC 09124
Identifier Type: -
Identifier Source: org_study_id
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