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.
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.
Participant is pregnant.
Inability to provide blood samples based on the judgment of the treating physician.
Advanced/metastatic breast cancer of following subtypes/lines of systemic therapy in metastatic setting: * Estrogen Receptor (ER)+/Human Epidermal growth factor Receptor 2 (HER2) - or Triple Negative (TN) patients prior to starting any line of systemic therapy * HER2+ patients prior to starting 2nd line or later therapy
Cohort
Prospective
Not listed
The percentage of subjects for which the providers indicated positive impact of the cfDNA/RNA, CTC enumeration, and CTC expression results.
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.
The correlation of CTC expression and tissue immunohistochemistry (IHC)/In Situ Hybridization (ISH) results for HER2, ER, and PD-L1.
The correlation of CTC expression and cfDNA/RNA results for HER2, ER, and PD-L1.
The correlation of CTC HER2, ER and PD-L1 expression with response to therapy and progression free survival (PFS).
The correlation of cfDNA/RNA genomic alterations with response to therapy and PFS.
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