QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer

Launched by ABRAMSON CANCER CENTER AT PENN MEDICINE · Aug 9, 2024

Keywords

ClinConnect Summary

The QuantifyHER clinical trial is studying a new method to measure a protein called HER2 in patients with a type of advanced breast cancer known as HER2-positive metastatic breast cancer. The goal is to see if this new testing approach can help doctors better identify which patients are likely to benefit from a specific treatment called T-DXd (Enhertu). This trial is currently recruiting participants who are 18 years or older and have confirmed metastatic breast cancer with a certain level of HER2 expression.

To be eligible for the study, participants must have measurable disease and provide tissue samples from their cancer for testing. They should also plan to start treatment with T-DXd soon. However, patients who have a more aggressive form of breast cancer that overexpresses HER2 won't be allowed to join. If you participate, you can expect to undergo some tests and assessments to help the researchers understand how effective the new HER2 measurement method is. This research could ultimately help improve treatment options for patients with similar conditions in the future.

Gender

ALL

Eligibility 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)