QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer
Purpose
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.
Condition
- HER2-positive Metastatic Breast Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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)
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| HER2 Assay | Analysis of HER2 expression via QIF and mRNA assays |
|
Recruiting Locations
University of California San Francisco Medical Center
San Francisco, California 94143
San Francisco, California 94143
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut 06418
Derby, Connecticut 06418
Smilow Cancer Hospital Care Center
Fairfield, Connecticut 06824
Fairfield, Connecticut 06824
Smilow Cancer Hospital at Glastonbury
Glastonbury, Connecticut 06033
Glastonbury, Connecticut 06033
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut 06830
Greenwich, Connecticut 06830
Smilow Cancer Hospital Care Center
Guilford, Connecticut 06437
Guilford, Connecticut 06437
Smilow Cancer Hospital at Saint Francis
Hartford, Connecticut 06105
Hartford, Connecticut 06105
Yale-New Haven Hospital North Haven Medical Center
New Haven, Connecticut 06473
New Haven, Connecticut 06473
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut 06901
Stamford, Connecticut 06901
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut 06790
Torrington, Connecticut 06790
Smilow Cancer Hospital Care Center
Trumbull, Connecticut 06611
Trumbull, Connecticut 06611
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut 06708
Waterbury, Connecticut 06708
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut 06385
Waterford, Connecticut 06385
Georgetown University - Lombardi CCC
Washington D.C., District of Columbia 20007
Washington D.C., District of Columbia 20007
MedStar Washington Hospital Center
Washington D.C., District of Columbia 20010
Washington D.C., District of Columbia 20010
Sibley Memorial Hospital
Washington D.C., District of Columbia 20016
Washington D.C., District of Columbia 20016
University of Chicago Medical Center
Chicago, Illinois 60637
Chicago, Illinois 60637
University of Chicago Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois 60451
New Lenox, Illinois 60451
University of Chicago Medicine-Orland Park
Orland Park, Illinois 60462
Orland Park, Illinois 60462
University of Chicago Medicine Northwest Indiana
Crown Point, Indiana 46307
Crown Point, Indiana 46307
Penn Medicine Princeton Medical Center
Plainsboro, New Jersey 08536
Plainsboro, New Jersey 08536
Montefiore Einstein Medical Center
The Bronx, New York 10467
The Bronx, New York 10467
UNC Chapel Hill
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Smilow Cancer Hospital Care Center
Westerly, Rhode Island 02891
Westerly, Rhode Island 02891
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas 77054
Houston, Texas 77054
University of Washington - Fred Hutchinson Cancer Center
Seattle, Washington 98109
Seattle, Washington 98109
More Details
- Status
- Recruiting
- Sponsor
- Abramson Cancer Center at Penn Medicine