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

NCT06408038 | Completed

• 1 other identifier: 24SEIN02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Metastatic Breast Cancer; CK+/CD45+; Double-Positive circulating cells

Outcome Measures

Primary Outcomes (1)

• Rate of patients with proven tumour origin of DP-circulating cells. This is defined as the number of patients with proven tumour origin of DP-circulating cells out of the number of patients with DP-circulating cells.

  Approximately 16 months after the start of the study

Secondary Outcomes (1)

• The presence and number of DP-circulating cells and conventional circulating tumor cells (CTCs).

  Approximately 16 months after the start of the study

Study Arms (1)

Patients with MBC

OTHER

Other: For each patient included, the samples described below will be collected:

Interventions

For each patient included, the samples described below will be collected: OTHER

* 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.

Patients with MBC

Eligibility Criteria

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

You may qualify if:

• Patients with metastatic breast cancer eligible for 1st, 2nd or 3rd line treatment at stage IV, regardless of immunohistochemical subtype (triple-negative, RH+/HER2-negative or HER2-positive).
• Patient with metastatic disease or metastatic relapse or progression who has not yet started 1st line treatment for metastatic disease or line 2 or line 3.
• Tumour sample available (archived tumour block): non-bone metastasis preferred if available or, failing this, primary breast tumour.
• Age ≥ 18 years and WHO ≤ 2.
• Patient affiliated to a French Social Security scheme.

You may not qualify if:

• Associated pathology(ies) likely to prevent the study procedure from running smoothly.
• Any psychological, family, geographical or sociological condition that prevents compliance with the medical monitoring and/or procedures set out in the study protocol.
• Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
• Patient who has presented with another solid tumour (excluding carcinoma in situ of the breast or cervix) within 5 years.
• Pregnant patient.

Sponsors & Collaborators

• Institut Claudius Regaud: lead
• Fondation Toulouse Cancer Santé: collaborator

Study Sites (1)

IUCT-O

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: June 25, 2024
• Primary Completion: October 8, 2025
• Study Completion: October 8, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-10

Locations

FR (1)