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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMenarini Silicon Biosystems, INC

About this trial

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 criteria

Qualifiers

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.

Subject must have the CTC HER2, ER, PD-L1, and cfDNA/RNA tests ordered during routine patient care.

Age > 18 years.

Disqualifiers

Participant is pregnant.

Inability to provide blood samples based on the judgment of the treating physician.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

187 Participants
are grouped into 2 trial groups