CTC and blood DNA/RNA testing for metastatic breast cancer
CTC-EXPRESS: A Prospective Observational Study for CTC Expression and cfDNA/RNA Assessment in Metastatic Breast Cancer
This project will test whether blood tests that count circulating tumor cells and analyze cell-free DNA/RNA can help guide treatment and monitoring for people with metastatic breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 187 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Menarini Silicon Biosystems, INC Industry-sponsored |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06833853 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study collecting blood samples to measure circulating tumor cell (CTC) counts and expression of HER2, ER, and PD-L1, along with cell-free DNA/RNA (cfDNA/RNA) profiling. Eligible adults with histologically confirmed metastatic or unresectable breast cancer will provide samples at baseline and at first restaging as part of routine care, with additional research collections as available. Treatments are chosen by each patient’s treating physician and are not dictated by the study. Blood collection involves multiple tubes (typically 4–6 at baseline and 3–4 at subsequent restaging) and testing uses the CellSearch platform for CTCs and a molecular assay for cfDNA/RNA.
Who should consider this trial
Good fit: Adults with histologically proven metastatic or unresectable breast cancer who meet the receptor-line criteria (HR+/HER2- or triple negative before first-line or beyond; HER2+ before second-line or beyond) and whose clinicians will order the CTC and cfDNA/RNA tests are ideal candidates.
Not a fit: People who are pregnant, cannot provide blood samples, have early-stage (non-metastatic) breast cancer, or whose clinicians do not order the CTC/cfDNA tests are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, these blood tests could help doctors choose and time treatments better and monitor response with minimally invasive samples.
How similar studies have performed: Previous research has shown that CTC counts and cfDNA can provide prognostic and molecular information, but using them routinely to guide treatment decisions has not yet been fully proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Magee Womens Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Marija Balic, MD, PhD, MBA — University of Pittsburgh
- Study coordinator: Marija Balic, MD, PhD, MBA
- Email: balicm@upmc.edu
- Phone: 800-533-8762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.