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Trial Title:
QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer
NCT ID:
NCT06551116
Condition:
HER2-positive Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
CE-10-IVD
Description:
Leftover tumor tissue from a routine biopsy will be sent for analysis.
Arm group label:
HER2 Assay
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.
Criteria for eligibility:
Study pop:
Patients with HER2 IHC1+ metastatic breast cancer, histologically confirmed
Sampling method:
Non-Probability Sample
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Abramson Cancer Center of the University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Angela DeMichele, MD
Phone:
855-216-0098
Email:
PennCancerTrials@emergingmed.com
Investigator:
Last name:
Angela DeMichele, MD
Email:
Principal Investigator
Start date:
October 10, 2024
Completion date:
September 1, 2029
Lead sponsor:
Agency:
Angela DeMichele
Agency class:
Other
Collaborator:
Agency:
Translational Breast Cancer Research Consortium
Agency class:
Other
Collaborator:
Agency:
Danaher Inc.
Agency class:
Other
Source:
Abramson Cancer Center at Penn Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06551116
