Status:
RECRUITING
QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Collaborating Sponsors:
Translational Breast Cancer Research Consortium
Danaher Inc.
Conditions:
HER2-positive Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 10 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06551116
Start Date
October 10 2024
End Date
September 1 2029
Last Update
September 5 2025
Active Locations (36)
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1
University of California San Francisco Medical Center
San Francisco, California, United States, 94143
2
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States, 06418
3
Smilow Cancer Hospital Care Center
Fairfield, Connecticut, United States, 06824
4
Smilow Cancer Hospital at Glastonbury
Glastonbury, Connecticut, United States, 06033