RecruitingNCT06551116

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

Sponsor

Abramson Cancer Center at Penn Medicine

Enrollment

200 participants

Start Date

Oct 10, 2024

Study Type

OBSERVATIONAL

Conditions

HER2-positive Metastatic Breast Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is trying to find better ways to measure the HER2 protein — a marker found on some breast cancer cells — to help doctors predict how well a drug called trastuzumab deruxtecan (T-DXd, sold as Enhertu) will work. Some patients have low HER2 levels that are hard to measure accurately with current tests, and this study wants to improve that measurement. **You may be eligible if...** - You are 18 or older with metastatic (spread) breast cancer - Your tumor shows at least a low level of HER2 (called HER2 1+) - You have measurable disease seen on scans - Your doctor is planning to start you on T-DXd (Enhertu) as your next treatment - You have tumor tissue available for testing **You may NOT be eligible if...** - Your tumor shows high HER2 levels (HER2 3+ or 2+ with gene amplification), which is a different subtype of HER2-positive breast cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTCE-10-IVD

Leftover tumor tissue from a routine biopsy will be sent for analysis.

Locations(37)

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

Penn Medicine Princeton Medical Center

Plainsboro, New Jersey, 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

View Full Details on ClinicalTrials.gov

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