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

NCT ID: NCT06408038

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-25
• Study Completion Date: 2025-10-08

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with MBC

Group Type: OTHER

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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 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).

2. 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.

3. Tumour sample available (archived tumour block): non-bone metastasis preferred if available or, failing this, primary breast tumour.

4. Age ≥ 18 years and WHO ≤ 2.

5. Patient affiliated to a French Social Security scheme.

6. Patient having signed his/her informed consent prior to inclusion in the study and prior to any specific procedure for the study.

Exclusion Criteria

1. Associated pathology(ies) likely to prevent the study procedure from running smoothly.

2. Any psychological, family, geographical or sociological condition that prevents compliance with the medical monitoring and/or procedures set out in the study protocol.

3. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

4. Patient who has presented with another solid tumour (excluding carcinoma in situ of the breast or cervix) within 5 years.

5. Pregnant patient.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Toulouse Cancer Santé

UNKNOWN

Sponsor Role: collaborator

Institut Claudius Regaud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IUCT-O

Toulouse, , France

Countries

France

Other Identifiers

24SEIN02

Identifier Type: -

Identifier Source: org_study_id