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

NCT06833853 | Recruiting

• 1 other identifier: CTC-EXPRESS
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer (MBC)

Keywords

CTC; cfDNA; cfRNA

Outcome Measures

Primary Outcomes (1)

• 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.

  3-4 months

Secondary Outcomes (6)

• 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

Study Arms (2)

HR+/HER2- subjects before starting 1st line therapy

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. Subjects will have additional cfDNA/RNA tests at week 4, and 8.

Triple negative starting any line of therapy, HR+/HER2-, and HER2+ starting ≥2nd line therapy

Subjects will receive CTC enumeration, and CTC HER2, ER, PD-L1 expression minimally before each restaging visit, and cfDNA/RNA assessments at baseline and first restaging as part of standard of care.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Participant is pregnant.
• Inability to provide blood samples based on the judgment of the treating physician.

Sponsors & Collaborators

• Menarini Silicon Biosystems, INC: lead

Study Sites (1)

UPMC Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marija Balic, MD, PhD, MBA

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marija Balic, MD, PhD, MBA

CONTACT

800-533-8762; balicm@upmc.edu

Lisette Stork-Sloots

CONTACT

lstork@medex15.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 19, 2025
• Study Start: March 13, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (1)