To hear about similar clinical trials, please enter your email below
Trial Title:
Are CK+/CD45+ Double-Positive Circulating Cells of Tumor-origin? Characterization in METAstatic Breast Cancer
NCT ID:
NCT06408038
Condition:
Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Metastatic Breast Cancer
CK+/CD45+
Double-Positive circulating cells
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
For each patient included, the samples described below will be collected:
Description:
- 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.
Arm group label:
Patients with MBC
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
IUCT-O
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Recruiting
Contact:
Last name:
Florence DALENC
Phone:
05 31 15 51 04
Email:
dalenc.florence@iuct-oncopole.fr
Start date:
June 25, 2024
Completion date:
January 2025
Lead sponsor:
Agency:
Institut Claudius Regaud
Agency class:
Other
Collaborator:
Agency:
Fondation Toulouse Cancer Santé
Agency class:
Other
Source:
Institut Claudius Regaud
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06408038
