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
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