A Study for CTC Expression and cfDNA/RNA Assessment in Metastatic Breast Cancer Patients
CTC-EXPRESS: A Prospective Observational Study for CTC Expression and cfDNA/RNA Assessment in Metastatic Breast Cancer
Menarini Silicon Biosystems, INC
187 participants
Mar 13, 2026
OBSERVATIONAL
Conditions
Summary
The purpose of this research is to learn if the CellSearch Circulating Tumor Cells (CTC) test can help doctors in making decisions about treatment and monitoring of breast cancer. The test consists of diagnostic CTC counts (enumeration) and expression of biomarkers Human Epidermal growth factor Receptor 2 (HER2), Estrogen Receptor (ER), and programmed death-ligand 1 (PD-L1) and cell free DNA/RNA (cfDNA/RNA) analysis.
Eligibility
Inclusion Criteria5
- Invasive breast cancer with radiographic and/or clinical evidence of advanced metastatic or unresectable disease.
- HR+/HER2 negative or triple negative (TN) subjects prior to starting first line therapy or beyond in the metastatic setting.
- OR HER2+ subjects prior to starting second line therapy or beyond in the metastatic setting.
- Subject must have the CTC HER2, ER, PD-L1, and cfDNA/RNA tests ordered during routine patient care.
- Age > 18 years.
Exclusion Criteria2
- Participant is pregnant.
- Inability to provide blood samples based on the judgment of the treating physician.
Interested in this trial?
Get notified about updates and connect with the research team.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06833853