QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer
Sponsored by Abramson Cancer Center at Penn Medicine
About this study
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.
Where this study is enrolling (36)
- I'm interested
University of California San Francisco Medical Center
San Francisco, California
- I'm interested
Yale-New Haven Hospital North Haven Medical Center
New Haven, Connecticut
- I'm interested
Smilow Cancer Hospital at Glastonbury
Glastonbury, Connecticut
- I'm interested
Smilow Cancer Hospital at Saint Francis
Hartford, Connecticut
- I'm interested
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut
Show all 36 locations
- I'm interested
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut
- I'm interested
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut
- I'm interested
Smilow Cancer Hospital Care Center
Fairfield, Connecticut
- I'm interested
Smilow Cancer Hospital Care Center
Guilford, Connecticut
- I'm interested
Smilow Cancer Hospital Care Center
Trumbull, Connecticut
- I'm interested
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut
- I'm interested
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut
- I'm interested
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut
- I'm interested
Yale Cancer Center
New Haven, Connecticut
- I'm interested
Sibley Memorial Hospital
Washington D.C., District of Columbia
- I'm interested
MedStar Washington Hospital Center
Washington D.C., District of Columbia
- I'm interested
Georgetown University - Lombardi CCC
Washington D.C., District of Columbia
- I'm interested
University of Chicago Medicine-Orland Park
Orland Park, Illinois
- I'm interested
University of Chicago Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois
- I'm interested
University of Chicago Medical Center
Chicago, Illinois
- I'm interested
University of Chicago Medicine Northwest Indiana
Crown Point, Indiana
- I'm interested
John's Hopkins Hospital
Baltimore, Maryland
- I'm interested
Penn Medicine Princeton Medical Center
Plainsboro, New Jersey
- I'm interested
Montefiore Einstein Medical Center
The Bronx, New York
- I'm interested
UNC Chapel Hill
Chapel Hill, North Carolina
- I'm interested
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania
- I'm interested
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania
- I'm interested
UPMC Hillman CC
Pittsburgh, Pennsylvania
- I'm interested
Smilow Cancer Hospital Care Center
Westerly, Rhode Island
- I'm interested
Ben Taub General Hospital
Houston, Texas
- I'm interested
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas
- I'm interested
MD Anderson Cancer center
Woodland, Texas
- I'm interested
MD Anderson Cancer center
Houston, Texas
- I'm interested
MD Anderson Cancer center
League City, Texas
- I'm interested
MD Anderson Cancer Center
Sugar Land, Texas
- I'm interested
University of Washington - Fred Hutchinson Cancer Center
Seattle, Washington
Who can participate
Inclusion criteria
- ✓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
Exclusion criteria
- ✕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)
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.