Breast CancerCARMMYCNCT04818125
Circulating Cancer Cells/Macrophage HYbrid Cells in Patients With Breast Cancer.
A study testing Patients with breast cancer (stage I, II III or IV) in people with Breast Cancer, run by Institut Claudius Regaud at 1 site in France.
Trial summary
Pilot, prospective, monocentric study aimed at evaluating the rate of patients with circulating cancer cell/macrophage hybrid cells in the peripheral blood. The study will be conducted on a population of patients with breast cancer (regardless of stage of the disease and the immunohistochemical subtype). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Patients with breast cancer (stage I, II III or IV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2021to 29 Jul 2022
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with breast cancer of any stage (stage I, II, III or IV) and any immunohistochemical subtype (triple-negative, HR+/HER2-negative or HER2-positive).
- Patient not yet initiated on specific treatment for the stage of breast cancer at inclusion.
- Available tumor sample (archived tumor block) : initial tumor or metastasis depending on the stage of the disease and availability.
- Age ≥ 18 years old.
- Patient affiliated to a Social Health Insurance in France.
- Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedure.
Who cannot join
- Associated pathology(ies) that may prevent the proper conduct of the procedure under consideration.
- Pregnant or breastfeeding woman.
- Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of 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 another solid tumor (except breast or cervix carcinoma in situ) within 5 years.
Trial locations and contacts
1 site in 1 country.
About this study
Pilot, prospective, monocentric study aimed at evaluating the rate of patients with circulating cancer cell/macrophage hybrid cells in the peripheral blood.
The study will be conducted on a population of patients with breast cancer (regardless of stage of the disease and the immunohistochemical subtype).
For each included patient, blood samples will be taken and tumor specimens will be collected for the study.
At the end of the blood collection, the patient will have completed his participation in the study.
- Conditions
- Breast Cancer
- Being tested
- Patients with breast cancer (stage I, II III or IV)
- Keywords
- Breast Cancer, Cancer cell/macrophage hybrid cells, Hybrid 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.
Patients with breast cancer (stage I, II III or IV)Other
Blood samples will be collected at different times:
- at Baseline for all patients with breast cancer: before initiation of treatment (i.e. before initiation of planned treatment for stage I to III patients and before any new line of treatment for stage IV patients);
- at the time of disease progression (or at 12 months in absence of progression) for patients with metastatic breast cancer (stage IV)
For each patient a tumor sample from the initial diagnosis of the disease (i.e. primary tumor +/- biopsy of a metastasis) will be collected (archived tumor block) for the study.
| Study group | Role | What they receive |
|---|---|---|
| Patients with breast cancer | Other | Not described Receives: Other: Patients with breast cancer (stage I, II III or IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with cancer cell / macrophage hybrid cells in peripheral blood defined as the ratio of the number of patients with hybrid cells to the total number of patients.
Measured: 20 months after the study start
Secondary outcomes (2)
Quantification of circulating hybrid cells in peripheral blood by automatic measurement (Cell Counter Corning) and expressed in number of cells / millilitre of blood.
Measured: 20 months after the study start
Progression-free survival (PFS) defined as the time from the date of inclusion to the date of progression or death from any cause.
Measured: 20 months after the study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start31 Mar 2021
- Primary completion29 Jul 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818125
- Sponsor's protocol ID
- 21 SEIN 01
- Acronym
- CARMMYC
- Status last verified
- Sep 2022
- First submitted
- 24 Mar 2021
- Last updated
- 28 Sep 2022
- 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 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Cancer Cells/Macrophage HYbrid Cells in Patients With Breast Cancer.
- ClinicalTrials.gov ID
- NCT04818125
- Acronym / sponsor ID
- CARMMYC / 21 SEIN 01
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Cancer cell/macrophage hybrid cells, Hybrid cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 26 Mar 2021 (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.
Pilot, prospective, monocentric study aimed at evaluating the rate of patients with circulating cancer cell/macrophage hybrid cells in the peripheral blood.
The study will be conducted on a population of patients with breast cancer (regardless of stage of the disease and the immunohistochemical subtype).
For each included patient, blood samples will be taken and tumor specimens will be collected for the study.
At the end of the blood collection, the patient will have completed his participation in the 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 breast cancer | Other | Other: Patients with breast cancer (stage I, II III or IV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with breast cancer of any stage (stage I, II, III or IV) and any immunohistochemical subtype (triple-negative, HR+/HER2-negative or HER2-positive).
- Patient not yet initiated on specific treatment for the stage of breast cancer at inclusion.
- Available tumor sample (archived tumor block) : initial tumor or metastasis depending on the stage of the disease and availability.
- Age ≥ 18 years old.
- Patient affiliated to a Social Health Insurance in France.
Key exclusion criteria (5 listed)
- Associated pathology(ies) that may prevent the proper conduct of the procedure under consideration.
- Pregnant or breastfeeding woman.
- Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of 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 another solid tumor (except breast or cervix carcinoma in situ) within 5 years.
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 |
|---|---|---|
| Patients with breast cancer (stage I, II III or IV)Blood samples will be collected at different times: * at Baseline for all patients with breast cancer: before initiation of treatment (i.e. before initiation of planned treatment for stage I to III patients and before any new line of treatment for stage IV patients); * at the time of disease progression (or at 12 months in absence of progression) for patients with metastatic breast cancer (stage IV) For each patient a tumor sample from the initial diagnosis of the disease (i.e. primary tumor +/- biopsy of a metastasis) will be collected (archived tumor block) for the study. | Other | Patients with breast cancer |
Primary outcome
Rate of patients with cancer cell / macrophage hybrid cells in peripheral blood defined as the ratio of the number of patients with hybrid cells to the total number of patients.
Time frame: 20 months after the study start
2 secondary outcomes
Quantification of circulating hybrid cells in peripheral blood by automatic measurement (Cell Counter Corning) and expressed in number of cells / millilitre of blood.
Time frame: 20 months after the study start
Progression-free survival (PFS) defined as the time from the date of inclusion to the date of progression or death from any cause.
Time frame: 20 months after the study start
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 28 Sep 2022.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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 Patients with breast cancer (stage I, II III or IV) in people with 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 28 Sep 2022. 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 cancer cell / macrophage hybrid cells in peripheral blood defined as the ratio of the number of patients with hybrid cells to the total number of patients. (time frame: 20 months after the study start). 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 28 Sep 2022.