HER2 Assay for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to measure HER2 protein levels in individuals with HER2-low metastatic breast cancer, aiming to determine if this method can predict response to a specific treatment called T-Dxd (Enhertu, an antibody-drug conjugate). The primary goal is to use a special test to identify patients who might benefit from T-Dxd and those who might not, potentially aiding doctors in making better treatment decisions. Suitable participants have metastatic breast cancer with a specific low level of HER2, plan to start T-Dxd, and have a tissue sample available for testing. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this HER2 assay is safe for patients with HER2 IHCI+ metastatic breast cancer?
Research has shown that CE-10-IVD, the focus of the QuantifyHER trial, is linked to the growing understanding of HER2, a protein that can influence cancer growth in breast cancer. While specific safety information about CE-10-IVD is not available, it is important to note that this trial involves studying HER2 levels, not administering a new drug or therapy. This suggests few safety concerns, as this type of test typically does not affect the body directly.
Additionally, other tests for HER2 have received approval for use, indicating that similar technologies are generally safe. However, since this trial tests a new method, discussing any concerns with the trial team is advisable. They can provide more details about any possible risks.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores new ways to measure HER2 levels in HER2-low metastatic breast cancer using Quantitative Immunofluorescence (QIF) and RT-qPCR assays. Unlike traditional methods that typically categorize HER2 status as simply positive or negative, this trial aims to quantify HER2 expression more precisely. By better defining HER2 levels, there’s potential to tailor treatments more accurately and improve outcomes for patients who might not benefit from current HER2-targeted therapies.
What evidence suggests that this HER2 assay is effective for identifying responders in metastatic breast cancer?
Research has shown that the treatment T-Dxd works well for tumors with less than 10% HER2 protein. HER2 is a protein that can influence the growth rate of breast cancer. Earlier studies have found this treatment promising for patients with low HER2 levels. In this trial, the CE-10-IVD measures HER2 levels more accurately, identifying those who might benefit from treatments like T-Dxd. Accurate HER2 measurement aids doctors in selecting the best treatment for each patient.46789
Who Is on the Research Team?
Angela DeMichele, MD
Principal Investigator
Abramson Cancer Center at Penn Medicine
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive T-DXd and undergo HER2 expression analysis via QIF and mRNA assays
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CE-10-IVD
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Analysis of HER2 expression via QIF and mRNA assays
Find a Clinic Near You
Who Is Running the Clinical Trial?
Angela DeMichele
Lead Sponsor
Abramson Cancer Center at Penn Medicine
Lead Sponsor
Translational Breast Cancer Research Consortium
Collaborator
Danaher Inc.
Collaborator
Citations
Inter‐rater agreement of HER2‐low scores between expert ...
Results for HER2‐low cases (N = 44) showed a kappa score range of 0.295 to 0.823; the VP APP ranked 12th of 17 (score 0.535 indicating moderate ...
International Expert Consensus Recommendations for ...
This is in conjunction with the DB-06 data showing that T-DXd is equally effective in the treatment of tumours with <10% faint, incomplete ...
Roche Gains CE IVDR Approval for Expanded HER2 ...
VENTANA HER2 (4B5) test is now CE-IVDR approved to identify HER2-ultralow breast cancer and HER2-positive biliary tract cancer patients.
Ventana Assay Earns CE IVDR Approval in EU as ...
The VENTANA HER2 (4B5) test earned CE-IVDR approval in Europe to assess HER2 status in metastatic breast cancer and biliary tract cancer.
5.
diagnostics.roche.com
diagnostics.roche.com/us/en/products/lab/her-2-neu-4b5-pathway-rtd001084.htmlPATHWAY® anti-HER-2/neu (4B5) Rabbit Monoclonal Antibody
Achieve consistently high proficiency assessment scores with the Roche HER2 (4B5) clone, compared to other clones2; Employ the most widely adopted and reliable ...
Molecular Biological Determination of HER2 Status Using ...
We established a laboratory-developed test (LDT) to analyze HER2 status not only at the gene expression level but also at the gene copy number.
7.
diagnostics.roche.com
diagnostics.roche.com/global/en/news-listing/2024/roche-obtains-ce-mark-for-first-companion-diagnostic-to-identify-patients-with-her2-low-metastatic-breast-cancer-eligible-for-enhertu.htmlRoche obtains CE Mark for first companion diagnostic to ...
Roche receives CE IVDR approval for HER2 (4B5) companion diagnostic test to identify HER2-ultralow breast cancer and biliary tract cancer ...
Companion diagnostics and HER2-targeted antibody-drug ...
This review specifically examines target antigen expression and the companion diagnostic (CDx) assays used to select patients for treatment with ...
Standardized pathology report for HER2 testing in compliance ...
Standardized pathology report for HER2 testing in compliance with 2023 ASCO/CAP updates and 2023 ESMO consensus statements on HER2-low breast cancer.
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