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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

Who can join

Ages 18 and older · All sexes

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.

About the study

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.

Sponsor: Menarini Silicon Biosystems, INC · Participants: 187 · Started: Mar 13, 2026

Contact the study team

• Marija Balic, MD, PhD, MBA · Phone: 800-533-8762

Official record on ClinicalTrials.gov — NCT06833853

Locations in the U.S.

Conditions

• Breast Cancer

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.