NCT06833853Recruiting
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
Source: ClinicalTrials.gov · Last updated 18 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 187 (estimated)
- First submitted
- 10 Feb 2025
- Start date
- 13 Mar 2026
- Primary completion date
- Oct 2028
- Lead sponsor
- Menarini Silicon Biosystems, INC
- Diseases
- Metastatic breast cancer
- NCT number
- NCT06833853
What you commit to
- Study type: Observational
- Planned participants: 187
- From 13 Mar 2026 to the primary completion date, Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Participant is pregnant.
- Inability to provide blood samples based on the judgment of the treating physician.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UPMC-Magee Womens Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.