A Study for CTC Expression and cfDNA/RNA Assessment in Metastatic Breast Cancer Patients
Recruiting
Observational Study
Metastatic Breast Cancer (MBC)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 187 (estimated)
- Sponsor
- Menarini Silicon Biosystems, INC · Industry
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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 (…
Trial Locations
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Eligibility Criteria
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…
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