NCT06408038

Are CK+/CD45+ Double-Positive Circulating Cells of Tumor-origin? Characterization in METAstatic Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, single-centre, proof-of-concept pilot study in patients with metastatic breast cancers (MBC) (whatever the immunohistochemical subtype) treated at the IUCT-O. Eligible patients will be selected and informed of this study during a medical consultation for cancer that has metastasised, has relapsed or is progressing metastatically, by medical oncologists at the Oncopole Claudius Regaud (OCR). Then, with the patient's agreement and before the start of anti-tumour treatment, a blood sample will be taken to detect DP-circulating cells. A breast cancer tumour sample (non-bone metastasis or, failing that, primary tumour) must be available (FFPE archived tumour block). Each patient will participate in the study for one day. 60 patients will be included in this interventional study.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
OTHER	For each patient included, the samples described below will be collected:	* A single blood sample will be taken before initiation of the metastatic treatment line. The volume of total blood sampled is 34mL. * A tumour sample (FFPE block already archived) from a metastasis (other than bone) if available or, failing this, from the primary breast tumour, will be sent to the sponsor in order to meet the objectives of the study. Once the blood sample has been taken, patients will have completed their participation in the study.

Timeline

• Start date: 2024-06-25
• Primary completion: 2025-10-08
• Completion: 2025-10-08
• First posted: 2024-05-09
• Last updated: 2025-11-18

Locations

1 site across 1 country: France