QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer
Recruiting · NCT06551116 · Observational (researchers observe without assigning treatment) · Lead sponsor: Abramson Cancer Center at Penn Medicine
View the official record on ClinicalTrials.gov →Interventions studied
CE-10-IVD
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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)
Where it is running
37 locations listed across 13 US states.
- 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