Actively Recruiting
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
N/A
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
Researchers are evaluating whether a quantitative HER2 assay can accurately distinguish between patients who respond and those who do not respond to T-Dxd treatment among individuals with HER2 IHCI+ metastatic breast cancer. The study focuses on patients with metastatic breast cancer that expresses low levels of HER2 and aims to improve understanding of treatment response. This observational research is sponsored by the Abramson Cancer Center at Penn Medicine. Participants will have leftover tumor tissue from routine biopsies analyzed using quantitative immunofluorescence and mRNA assays to measure HER2 expression. The study involves collecting data on HER2 levels and monitoring treatment outcomes as patients receive T-Dxd at FDA-approved doses and schedules. Analysis includes evaluating HER2 expression via these assays to assess their ability to predict response to therapy. During the study, researchers will collect information on patients' responses to T-Dxd, including real-world objective response rates and progression-free survival over a period of up to 100 months. They will also examine associations between HER2 assay results and treatment outcomes, considering factors such as estrogen receptor status. Participants provide informed consent, and data from imaging and biopsy samples will be used to assess measurable disease and biomarker levels throughout the study.
CONDITIONS
Brief Title
QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women and men age > 18 years
- Histologically confirmed metastatic breast cancer with any estrogen receptor status
- Tumor with 1+ HER2 expression level by immunohistochemistry as per ASCO/CAP guidelines
- Measurable disease by cross-sectional imaging at treatment start, including bone-only disease or active brain metastases
- Availability of archival tissue for biomarker testing, including recent metastatic biopsy and any specimen indicating HER2 1+ status
- Intention to start or recent start (within 30 days) of T-DXd therapy at FDA-approved dose and schedule
- Ability to provide informed consent
You will not qualify if you...
- Concurrent HER2-overexpressing metastatic breast cancer confirmed by biopsy showing IHC 3+ or IHC 2+ with FISH amplification as per ASCO/CAP guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Leftover tumor tissue from a routine biopsy is sent for analysis of HER2 expression via quantitative immunofluorescence and/or RT-qPCR.
1 visit (tissue collection during routine biopsy)
Duration - Up to 100 months
Participants are monitored over time to assess objective response rate and progression-free survival related to their treatment with T-DXd.
Visits according to routine clinical care
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
Research Team
A
Angela DeMichele, MD
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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