NCT06551116 QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer
| NCT ID | NCT06551116 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abramson Cancer Center at Penn Medicine |
| Condition | HER2-positive Metastatic Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-10-10 |
| Primary Completion | 2029-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-10-10 with a primary completion date of 2029-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 receiving T-Dxd.
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)
Contact & Investigator
Angela DeMichele, MD
PRINCIPAL INVESTIGATOR
Abramson Cancer Center at Penn Medicine
Frequently Asked Questions
Who can join the NCT06551116 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HER2-positive Metastatic Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06551116 currently recruiting?
Yes, NCT06551116 is actively recruiting participants. Contact the research team at angela.demichele@pennmedicine.upenn.edu for enrollment information.
Where is the NCT06551116 trial being conducted?
This trial is being conducted at San Francisco, United States, Derby, United States, Fairfield, United States, Glastonbury, United States and 11 additional locations.
Who is sponsoring the NCT06551116 clinical trial?
NCT06551116 is sponsored by Abramson Cancer Center at Penn Medicine. The principal investigator is Angela DeMichele, MD at Abramson Cancer Center at Penn Medicine. The trial plans to enroll 200 participants.
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