Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer (MBC) | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- HR+/HER2- subjects before starting 1st line therapy
- description
- Subjects will receive CTC enumeration, CTC HER2, ER, PD-L1 expression and, and MSearch cfDNA/RNA assessments at baseline and first restaging as part of standard of care. Subjects will have additional cfDNA/RNA tests at week 4, and 8.
- label
- Triple negative starting any line of therapy, HR+/HER2-, and HER2+ starting ≥2nd line therapy
- description
- Subjects will receive CTC enumeration, and CTC HER2, ER, PD-L1 expression minimally before each restaging visit, and cfDNA/RNA assessments at baseline and first restaging as part of standard of care.
Primary outcomes (1)
- measure
- The percentage of subjects for which the providers indicated positive impact of the cfDNA/RNA, CTC enumeration, and CTC expression results.
- timeFrame
- 3-4 months
- description
- The percentage of subjects for which the providers indicated positive impact on treatment decisions or response assessment of the cfDNA/RNA, CTC enumeration, and CTC expression assessments.CTC enumeration, CTC biomarker expression, and cfDNA/RNA results in subjects with MBC.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available