NCT06408038Completed
Are CK+/CD45+ Double-Positive Circulating Cells of Tumor-origin? Characterization in METAstatic Breast Cancer
Source: ClinicalTrials.gov · Last updated 18 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 6 May 2024
- Start date
- 25 Jun 2024
- Primary completion date
- 8 Oct 2025
- Lead sponsor
- Institut Claudius Regaud
- Diseases
- Metastatic breast cancer
- NCT number
- NCT06408038
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 25 Jun 2024 to the primary completion date, 8 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any psychological, family, geographical or sociological condition that prevents compliance with the medical monitoring and/or procedures set out in the study protocol.
Other
- Associated pathology(ies) likely to prevent the study procedure from running smoothly.
- 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.
Who the study is looking for
- 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.
- Patient having signed his/her informed consent prior to inclusion in the study and prior to any specific procedure for the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IUCT-O Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.