Clinical trial NCT06833853: A Study for CTC Expression and cfDNA/RNA Assessment in Metastatic Breast Cancer Patients
Official title: CTC-EXPRESS: A Prospective Observational Study for CTC Expression and cfDNA/RNA Assessment in Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Metastatic Breast Cancer (MBC)
Keywords: CTC
cfDNA
cfRNA
Lead sponsor: Menarini Silicon Biosystems, INC
Sponsor class: INDUSTRY
First posted: 2025-02-19
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.

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.

Primary outcomes:
measure: The percentage of subjects for which the providers indicated positive impact of the cfDNA/RNA, CTC enumeration, and CTC expression results.
timeFrame: 3-4 months
Secondary outcomes:
measure: The correlation of CTC expression and tissue immunohistochemistry (IHC)/In Situ Hybridization (ISH) results for HER2, ER, and PD-L1.
timeFrame: 1 month
measure: The correlation of CTC expression and cfDNA/RNA results for HER2, ER, and PD-L1.
timeFrame: 3-4 months
measure: The correlation of CTC HER2, ER and PD-L1 expression with response to therapy and progression free survival (PFS).
timeFrame: 24 months
measure: The correlation of cfDNA/RNA genomic alterations with response to therapy and PFS.
timeFrame: 24 months
measure: The correlation of early cfDNA/RNA dynamics with response to therapy and PFS in 1st line Hormone Receptor (HR) +/HER2- MBC.
timeFrame: 24 months
measure: The correlation of CTC enumeration results with PFS.
timeFrame: 24 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Magee Womens Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Marija Balic, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: