A Study for CTC Expression and cfDNA/RNA Assessment in Metastatic Breast Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Metastatic Breast Cancer (MBC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
CTC-EXPRESS: A Prospective Observational Study for CTC Expression and cfDNA/RNA Assessment in Metastatic Breast Cancer
Overview
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.
Detailed description
A prospective, multicenter, observational study of CellSearch CTC enumeration, CTC HER2, ER, and PD-L1 expression, and MSearch cfDNA/RNA results in subjects with histologically proven MBC. Treatment for MBC will be chosen and performed by treating physicians/providers. Eligible subjects will be enrolled after signing the ICF. 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 (SoC). Subjects will receive any additional cfDNA/RNA assessments as part of research collection. For all subjects 4 to 6 tubes will be collected at baseline and minimally before the first restaging visit. For any subsequent restaging visits a total of 3 to 4 tubes will be collected.
Primary outcome measures
- 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]
Secondary outcome measures (6)
- The correlation of CTC expression and tissue immunohistochemistry (IHC)/In Situ Hybridization (ISH) results for HER2, ER, and PD-L1. [Time frame: 1 month]
- The correlation of CTC expression and cfDNA/RNA results for HER2, ER, and PD-L1. [Time frame: 3-4 months]
- The correlation of CTC HER2, ER and PD-L1 expression with response to therapy and progression free survival (PFS). [Time frame: 24 months]
- The correlation of cfDNA/RNA genomic alterations with response to therapy and PFS. [Time frame: 24 months]
- The correlation of early cfDNA/RNA dynamics with response to therapy and PFS in 1st line Hormone Receptor (HR) +/HER2- MBC. [Time frame: 24 months]
- The correlation of CTC enumeration results with PFS. [Time frame: 24 months]
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- UPMC Magee Womens Hospital — Pittsburgh
Identifiers
NCT: NCT06833853 · CTC-EXPRESS