QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer
- Conditions
- HER2-positive Metastatic Breast Cancer
- Interventions
- Diagnostic Test: CE-10-IVD
- Registration Number
- NCT06551116
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HER2 Assay CE-10-IVD Analysis of HER2 expression via QIF and mRNA assays
- Primary Outcome Measures
Name Time Method Real-World Objective Response Rate from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months Association between quantitative HER2 expression (as a continuous variable) and real-world objective response rate
- Secondary Outcome Measures
Name Time Method Association between combined mRNA + QIF and real-world Objective Response Rate from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months Comparison, based on rwORR, of a linear combination of HER2 QIF and mRNA, versus either alone in ability to discriminate T-DXd responders from non- responders
Real-World Progression Free Survival from date of first dose of T-DXd to date of last dose of T-DXd for each.Up to 100 months Association between quantitative HER2 expression (as a continuous variable) and real world Progression Free Survival
Threshold for HER2 QIF and/or mRNA levels from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months cut-off value for HER2 QIF, mRNA and the combination below which patients will not respond to T-DXd."
Real-World Progression Free Survival and Objective Response Rate by estrogen receptor expression from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months Association between HER2 expression by quantitative immunofluorescence and mRNA in HER2 IHC 1+ tumors and both rwORR and rwPFS, stratified by mRNA ER expression
Trial Locations
- Locations (20)
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, District of Columbia, United States
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
MD Anderson Cancer center
🇺🇸Woodland, Texas, United States
MD Anderson Cancer Center
🇺🇸Sugar Land, Texas, United States
University of Washington - Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States
Smilow Cancer Hospital Care Center
🇺🇸Westerly, Rhode Island, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Smilow Cancer Hospital Care Center at Greenwich
🇺🇸Greenwich, Connecticut, United States
University of Chicago Comprehensive Cancer Center at Silver Cross
🇺🇸New Lenox, Illinois, United States
Smilow Cancer Hospital Care Center at Long Ridge
🇺🇸Stamford, Connecticut, United States
University of Chicago Medicine-Orland Park
🇺🇸Orland Park, Illinois, United States
Smilow Cancer Hospital at Glastonbury
🇺🇸Glastonbury, Connecticut, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
University of Chicago Medicine Northwest Indiana
🇺🇸Crown Point, Indiana, United States
Smilow Cancer Hospital-Derby Care Center
🇺🇸Derby, 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
Smilow Cancer Hospital-Torrington Care Center
🇺🇸Torrington, Connecticut, United States