A Study for CTC Expression and cfDNA/RNA Assessment in Metastatic Breast Cancer Patients

Conditions

• Metastatic Breast Cancer (MBC)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

Start date

Mar 13, 2026

Status verified

Mar 2026

Primary completion

Oct 31, 2028

Completion

Oct 31, 2028

Study Design

Enrollment

187 participants (estimated)

Arms

• Arm: HR+/HER2- subjects before starting 1st line therapy
  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.
• Arm: Triple negative starting any line of therapy, HR+/HER2-, and HER2+ starting ≥2nd line therapy
  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 Outcome Measure

The percentage of subjects for which the providers indicated positive impact of the cfDNA/RNA, CTC enumeration, and CTC expression results. [ Time Frame: 3-4 months ]

Central Contacts

• Marija Balic, MD, PhD, MBA
  800-533-8762
  [email protected]
• Lisette Stork-Sloots
  [email protected]

Locations (1)

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