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

Not yet recruiting

• Conditions: Metastatic Breast Cancer (MBC)

• Registration Number: NCT06833853
• Lead Sponsor: Menarini Silicon Biosystems, INC

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.

Study Timeline

• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-13
• Study First Posted: 2025-02-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06
• Study Start: 2025-07-01
• Primary Completion: 2027-07-01
• Study Completion: 2029-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 187

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of subjects for which the providers indicated positive impact of the cfDNA/RNA, CTC enumeration, and CTC expression results.	3-4 months	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.

Secondary Outcome Measures

Name	Time	Method
The correlation of CTC expression and tissue immunohistochemistry (IHC)/In Situ Hybridization (ISH) results for HER2, ER, and PD-L1.	1 month
The correlation of CTC expression and cfDNA/RNA results for HER2, ER, and PD-L1.	3-4 months
The correlation of CTC HER2, ER and PD-L1 expression with response to therapy and progression free survival (PFS).	24 months
The correlation of cfDNA/RNA genomic alterations with response to therapy and PFS.	24 months
The correlation of early cfDNA/RNA dynamics with response to therapy and PFS in 1st line Hormone Receptor (HR) +/HER2- MBC.	24 months
The correlation of CTC enumeration results with PFS.	24 months

Trial Locations

Locations (1)

UPMC Magee Womens Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States