RecruitingNCT06833853

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


Sponsor

Menarini Silicon Biosystems, INC

Enrollment

187 participants

Start Date

Mar 13, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study collects blood samples from people with advanced or metastatic breast cancer to test for circulating tumor cells and bits of tumor DNA/RNA floating in the bloodstream. Researchers want to learn whether these tests can help predict how well treatments are working. **You may be eligible if...** - You are over 18 years old - You have invasive breast cancer that has spread and cannot be surgically removed - You have hormone receptor-positive, HER2-negative, or triple-negative breast cancer starting first-line therapy or later - Or you have HER2-positive breast cancer starting second-line therapy or later - Your doctor has already ordered circulating tumor cell and cfDNA/RNA tests as part of your routine care **You may NOT be eligible if...** - You are pregnant - Your doctor determines you are unable to safely provide blood samples Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

UPMC Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

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NCT06833853


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