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Clinical Trials in the USA / NCT06833853
Recruiting Observational

A Study for CTC Expression and cfDNA/RNA Assessment in Metastatic Breast Cancer Patients

NCT06833853 · tracked via the Priya Life Science USA tracker
Sponsor
Menarini Silicon Biosystems, INC
Phase
Observational
Started
2026-03-13
Last updated
2026-03-18

Condition(s) studied

Metastatic Breast Cancer (MBC)

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * Participant is pregnant. * Inability to provide blood samples based on the judgment of the treating physician.

Primary outcome measure(s)

  • The percentage of subjects for which the providers indicated positive impact of the cfDNA/RNA, CTC enumeration, and CTC expression results. — 3-4 months
    The percentage of subjects for which the providers indicated positive impact on treatment decisions or response assessment of the cfDNA/RNA, CTC enumeration, and CTC expression assessments.CTC enumeration, CTC biomarker expression, and cfDNA/RNA results in subjects with MBC.

Trial sites (1)

FacilityCityRegionStatus
UPMC Magee Womens Hospital Pittsburgh Pennsylvania Recruiting

More Menarini Silicon Biosystems, INC trials in the USA

ACT-MBC: A Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer (MBC) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06833853 on ClinicalTrials.gov ↗ ← All trials in the USA