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

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.

ClinicalTrials.gov IDNCT06833853

PhaseNot Applicable

Enrollment187

SponsorMenarini Silicon Biosystems, INC

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Metastatic Breast Cancer (MBC)

About this study

Primary outcomes

The percentage of subjects for which the providers indicated positive impact of the cfDNA/RNA, CTC enumeration, and CTC expression results. (3-4 months)

Eligibility information

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.

Study locations

UPMC Magee Womens Hospital, Pittsburgh, Pennsylvania 15213 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.