Recruiting

CellSearch CTC

Sponsor:

Menarini Silicon Biosystems, INC

Code:

NCT06833853

Conditions

Metastatic Breast Cancer (MBC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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)

Study ID

NCT06833853

Start date

Mar 13, 2026

Status verified date

Mar, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

187 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Marija Balic, MD, PhD, MBA

800-533-8762balicm@upmc.edu

Lisette Stork-Sloots

lstork@medex15.com

Locations

UPMC Magee Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

More Information

Sponsor

Menarini Silicon Biosystems, INC

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Keywords

  • CTC
  • cfDNA
  • cfRNA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Menarini Silicon Biosystems, INC on 2026-03-18.