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

NCT06551116 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-04-07

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

CE-10-IVD

Leftover tumor tissue from a routine biopsy will be sent for analysis.

Sponsors & Collaborators

  • Translational Breast Cancer Research Consortium

    collaborator OTHER

  • Danaher Inc.

    collaborator UNKNOWN

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Principal Investigators

  • Angela DeMichele, MD · Abramson Cancer Center at Penn Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-10
Primary Completion
2029-09-01
Completion
2029-09-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06551116 on ClinicalTrials.gov