Actively Recruiting
QuantifyHER Study to Measure HER2 Levels Using Immunofluorescence and RT-qPCR in Adults with HER2-low Metastatic Breast Cancer Receiving T-DXd
Led by Abramson Cancer Center at Penn Medicine · Updated on 2026-07-08
200
Participants Needed
37
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating whether a quantitative HER2 assay can accurately distinguish responders from non-responders among patients with HER2-low metastatic breast cancer receiving T-Dxd. This observational study focuses on improving measurement methods for HER2 expression levels to better understand treatment response. Participants provide leftover tumor tissue from routine biopsies for analysis using quantitative immunofluorescence and RT-qPCR assays. The study measures HER2 expression via these tests and correlates results with real-world treatment responses and progression over up to 100 months following the start of T-Dxd therapy. During the study, researchers collect data on tumor HER2 levels and track objective response rates and progression-free survival. Imaging and biomarker assessments are used to evaluate measurable disease, including bone and brain metastases. Participants are monitored throughout their treatment with T-Dxd, with up to 100 months of follow-up to assess outcomes and associations with HER2 assay results.
CONDITIONS
Brief Title
QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer
Research Team
A
Angela DeMichele, MD
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