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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Kobiety i mężczyźni powyżej 18 lat.
  • Rak piersi z przerzutami, potwierdzony badaniem histopatologicznym. Możliwy jest każdy stan receptora estrogenowego (ER).
  • Guz pierwotny lub z przerzutami z ekspresją HER2 na poziomie 1+ (według określonych wytycznych).
  • Choroba możliwa do zmierzenia na początku leczenia. Pacjenci z ograniczonymi przerzutami tylko w kościach lub z aktywnymi przerzutami do mózgu mogą wziąć udział.
  • Dostępna tkanka archiwalna do badań. Najnowsza biopsja przerzutu jest wymagana. Jeśli HER2 1+ określono na innej próbce, też jest potrzebna.
  • Zamiar rozpoczęcia leczenia lekiem T-DXd (Enhertu) w zalecanej dawce jako kolejny etap terapii. Jeśli leczenie już się rozpoczęło, pacjent musi być zarejestrowany w ciągu 30 dni od jego rozpoczęcia.
  • Zdolność do wyrażenia świadomej zgody.

✗ Disqualifies

  • Rak piersi z przerzutami, który nadmiernie produkuje HER2 (potwierdzony biopsją przerzutu z wynikiem 3+ lub 2+ z amplifikacją FISH, według standardowych wytycznych).

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 8, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (37)

University of California San Francisco Medical Center

San Francisco, United States

Smilow Cancer Hospital-Derby Care Center

Derby, United States

Smilow Cancer Hospital Care Center

Fairfield, United States

Smilow Cancer Hospital at Glastonbury

Glastonbury, United States

Smilow Cancer Hospital Care Center at Greenwich

Greenwich, United States

Smilow Cancer Hospital Care Center

Guilford, United States

Smilow Cancer Hospital at Saint Francis

Hartford, United States

Yale-New Haven Hospital North Haven Medical Center

New Haven, United States

Yale Cancer Center

New Haven, United States

Smilow Cancer Hospital Care Center at Long Ridge

Stamford, United States

Smilow Cancer Hospital-Torrington Care Center

Torrington, United States

Smilow Cancer Hospital Care Center

Trumbull, United States

Smilow Cancer Hospital-Waterbury Care Center

Waterbury, United States

Smilow Cancer Hospital Care Center - Waterford

Waterford, United States

Georgetown University - Lombardi CCC

Washington D.C., United States

MedStar Washington Hospital Center

Washington D.C., United States

Sibley Memorial Hospital

Washington D.C., United States

University of Chicago Medical Center

Chicago, United States

University of Chicago Comprehensive Cancer Center at Silver Cross

New Lenox, United States

University of Chicago Medicine-Orland Park

Orland Park, United States

University of Chicago Medicine Northwest Indiana

Crown Point, United States

John's Hopkins Hospital

Baltimore, United States

Penn Medicine Princeton Medical Center

Plainsboro, United States

Montefiore Einstein Medical Center

The Bronx, United States

UNC Chapel Hill

Chapel Hill, United States

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, United States

University of Pittsburgh Medical Center

Pittsburgh, United States

UPMC Hillman CC

Pittsburgh, United States

Smilow Cancer Hospital Care Center

Westerly, United States

Ben Taub General Hospital

Houston, United States

MD Anderson Cancer center

Houston, United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, United States

MD Anderson Cancer Center

Houston, United States

MD Anderson Cancer center

League City, United States

MD Anderson Cancer Center

Sugar Land, United States

MD Anderson Cancer center

Woodland, United States

University of Washington - Fred Hutchinson Cancer Center

Seattle, United States

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.

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