Recruiting
QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer
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.
ClinicalTrials.gov IDNCT06551116
PhaseNot Applicable
Enrollment200
SponsorAbramson Cancer Center at Penn Medicine
Age18 Years
SexALL
Conditions studied
HER2-positive Metastatic Breast Cancer
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.
Interventions
- Diagnostic Test: CE-10-IVD — Leftover tumor tissue from a routine biopsy will be sent for analysis.
Primary outcomes
- 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)
Eligibility information
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 locations
- University of California San Francisco Medical Center, San Francisco, California 94143 United States
- Smilow Cancer Hospital-Derby Care Center, Derby, Connecticut 06418 United States
- Smilow Cancer Hospital Care Center, Fairfield, Connecticut 06824 United States
- Smilow Cancer Hospital at Glastonbury, Glastonbury, Connecticut 06033 United States
- Smilow Cancer Hospital Care Center at Greenwich, Greenwich, Connecticut 06830 United States
- Smilow Cancer Hospital Care Center, Guilford, Connecticut 06437 United States
- Smilow Cancer Hospital at Saint Francis, Hartford, Connecticut 06105 United States
- Yale-New Haven Hospital North Haven Medical Center, New Haven, Connecticut 06473 United States
- Yale Cancer Center, New Haven, Connecticut 06511 United States
- Smilow Cancer Hospital Care Center at Long Ridge, Stamford, Connecticut 06901 United States
Showing 10 of 37 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.