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

Recruiting now

Conditions studied: HER2-positive Metastatic Breast Cancer

In brief

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 receiving T-Dxd.

Key facts

Study ID

NCT06551116

Run by

Abramson Cancer Center at Penn Medicine

People needed

200

Starts

2024-10-10

Expected to finish

2029-09-01

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of California San Francisco Medical Center — San Francisco, California, United States (enrolling)
• Smilow Cancer Hospital-Derby Care Center — Derby, Connecticut, United States (enrolling)
• Smilow Cancer Hospital Care Center — Fairfield, Connecticut, United States (enrolling)
• Smilow Cancer Hospital at Glastonbury — Glastonbury, Connecticut, United States (enrolling)
• Smilow Cancer Hospital Care Center at Greenwich — Greenwich, Connecticut, United States (enrolling)
• Smilow Cancer Hospital Care Center — Guilford, Connecticut, United States (enrolling)
• Smilow Cancer Hospital at Saint Francis — Hartford, Connecticut, United States (enrolling)
• Yale-New Haven Hospital North Haven Medical Center — New Haven, Connecticut, United States (enrolling)
• Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
• Smilow Cancer Hospital Care Center at Long Ridge — Stamford, Connecticut, United States (enrolling)
• Smilow Cancer Hospital-Torrington Care Center — Torrington, Connecticut, United States (enrolling)
• Smilow Cancer Hospital Care Center — Trumbull, Connecticut, United States (enrolling)
• Smilow Cancer Hospital-Waterbury Care Center — Waterbury, Connecticut, United States (enrolling)
• Smilow Cancer Hospital Care Center - Waterford — Waterford, Connecticut, United States (enrolling)
• Georgetown University - Lombardi CCC — Washington D.C., District of Columbia, United States (enrolling)
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
• Sibley Memorial Hospital — Washington D.C., District of Columbia, United States (enrolling)
• University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
• University of Chicago Comprehensive Cancer Center at Silver Cross — New Lenox, Illinois, United States (enrolling)
• University of Chicago Medicine-Orland Park — Orland Park, Illinois, United States (enrolling)
• University of Chicago Medicine Northwest Indiana — Crown Point, Indiana, United States (enrolling)
• John's Hopkins Hospital — Baltimore, Maryland, United States (enrolling)
• Penn Medicine Princeton Medical Center — Plainsboro, New Jersey, United States (enrolling)
• Montefiore Einstein Medical Center — The Bronx, New York, United States (enrolling)
• UNC Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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