Actively Recruiting

Age: 18Years +
All Genders
NCT06551116

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

Led by Abramson Cancer Center at Penn Medicine · Updated on 2026-04-07

200

Participants Needed

37

Research Sites

255 weeks

Total Duration

On this page

Sponsors

A

Abramson Cancer Center at Penn Medicine

Lead Sponsor

T

Translational Breast Cancer Research Consortium

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Women and men age > 18 years
  • Histologically confirmed metastatic breast cancer with any estrogen receptor status
  • Tumor shows 1+ HER2 expression by immunohistochemistry per ASCO/CAP guidelines
  • Measurable disease by imaging, including bone-only disease or active brain metastases
  • Archival tissue available for biomarker testing, including recent metastatic biopsy
  • Intend to start or have started T-DXd therapy at FDA-approved dose and schedule within 30 days
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Concurrent HER2-overexpressing metastatic breast cancer confirmed by biopsy with IHC 3+ or IHC 2+ with FISH amplification according to ASCO/CAP guidelines

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 37 locations

1

University of California San Francisco Medical Center

San Francisco, California, United States, 94143

Actively Recruiting

2

Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut, United States, 06418

Actively Recruiting

3

Smilow Cancer Hospital Care Center

Fairfield, Connecticut, United States, 06824

Actively Recruiting

4

Smilow Cancer Hospital at Glastonbury

Glastonbury, Connecticut, United States, 06033

Actively Recruiting

5

Smilow Cancer Hospital Care Center at Greenwich

Greenwich, Connecticut, United States, 06830

Actively Recruiting

6

Smilow Cancer Hospital Care Center

Guilford, Connecticut, United States, 06437

Actively Recruiting

7

Smilow Cancer Hospital at Saint Francis

Hartford, Connecticut, United States, 06105

Actively Recruiting

8

Yale-New Haven Hospital North Haven Medical Center

New Haven, Connecticut, United States, 06473

Actively Recruiting

9

Yale Cancer Center

New Haven, Connecticut, United States, 06511

Actively Recruiting

10

Smilow Cancer Hospital Care Center at Long Ridge

Stamford, Connecticut, United States, 06901

Actively Recruiting

11

Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut, United States, 06790

Actively Recruiting

12

Smilow Cancer Hospital Care Center

Trumbull, Connecticut, United States, 06611

Actively Recruiting

13

Smilow Cancer Hospital-Waterbury Care Center

Waterbury, Connecticut, United States, 06708

Actively Recruiting

14

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, United States, 06385

Actively Recruiting

15

Georgetown University - Lombardi CCC

Washington D.C., District of Columbia, United States, 20007

Actively Recruiting

16

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

17

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States, 20016

Actively Recruiting

18

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

Actively Recruiting

19

University of Chicago Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States, 60451

Actively Recruiting

20

University of Chicago Medicine-Orland Park

Orland Park, Illinois, United States, 60462

Actively Recruiting

21

University of Chicago Medicine Northwest Indiana

Crown Point, Indiana, United States, 46307

Actively Recruiting

22

John's Hopkins Hospital

Baltimore, Maryland, United States, 21287

Actively Recruiting

23

Penn Medicine Princeton Medical Center

Plainsboro, New Jersey, United States, 08536

Actively Recruiting

24

Montefiore Einstein Medical Center

The Bronx, New York, United States, 10467

Actively Recruiting

25

UNC Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

26

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

27

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

28

UPMC Hillman CC

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

29

Smilow Cancer Hospital Care Center

Westerly, Rhode Island, United States, 02891

Actively Recruiting

30

Ben Taub General Hospital

Houston, Texas, United States, 77030

Actively Recruiting

31

MD Anderson Cancer center

Houston, Texas, United States, 77030

Actively Recruiting

32

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, United States, 77054

Actively Recruiting

33

MD Anderson Cancer Center

Houston, Texas, United States, 77079

Actively Recruiting

34

MD Anderson Cancer center

League City, Texas, United States, 77573

Actively Recruiting

35

MD Anderson Cancer Center

Sugar Land, Texas, United States, 77478

Actively Recruiting

36

MD Anderson Cancer center

Woodland, Texas, United States, 77384

Actively Recruiting

37

University of Washington - Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

Actively Recruiting

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Research Team

A

Angela DeMichele, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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