Metastatic Breast CancerDP METABREASTNCT06408038
Are CK+/CD45+ Double-Positive Circulating Cells of Tumor-origin? Characterization in METAstatic Breast Cancer
A study testing For each patient included, the samples described below will be collected: in people with Metastatic Breast Cancer, run by Institut Claudius Regaud at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- For each patient included, the samples described below will be collected:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2024to 8 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- For each patient included, the samples described below will be collected:
- Keywords
- Metastatic Breast Cancer, CK+/CD45+, Double-Positive circulating cells
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with MBC | Other | Not described Receives: Other: For each patient included, the samples described below will be collected: |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
The heterogeneity of DP-circulating cells will be estimated by the penetrance of genomic alterations in a given patient, which will give us information on the sub-clonality of the alteration (shared by x percent of cells), but also by single cell DNA sequencing (scDNAseq).
Measured: Approximately 16 months after the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start25 Jun 2024
- Primary completion8 Oct 2025
- Study completion8 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Toulouse Cancer Santé
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408038
- Sponsor's protocol ID
- 24SEIN02
- Acronym
- DP METABREAST
- Status last verified
- Oct 2025
- First submitted
- 6 May 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are CK+/CD45+ Double-Positive Circulating Cells of Tumor-origin? Characterization in METAstatic Breast Cancer
- ClinicalTrials.gov ID
- NCT06408038
- Acronym / sponsor ID
- DP METABREAST / 24SEIN02
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer, CK+/CD45+, Double-Positive circulating cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Collaborators
- Fondation Toulouse Cancer Santé
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 8 Oct 2025 (actual)
- Study completion
- 8 Oct 2025 (actual)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with MBC | Other | Other: For each patient included, the samples described below will be collected: |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Patients with MBC |
Primary outcome
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.
Time frame: Approximately 16 months after the start of the study
1 secondary outcome
The presence and number of DP-circulating cells and conventional circulating tumor cells (CTCs).
Time frame: Approximately 16 months after the start of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing For each patient included, the samples described below will be collected: in people with Metastatic Breast Cancer, run by Institut Claudius Regaud at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Approximately 16 months after the start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.