Breast CancerIMMUNE CAPTURENCT04925856
Immunomonitoring of Breast Cancer Patients During Systemic Treatment
A study testing blood sample in people with Breast Cancer, run by Centre Georges Francois Leclerc at 2 sites in France.
Trial summary
This study aims to constitute a most complete biological collection for patients treated for localized or metastatic breast cancer (in different cohorts depending on the type of systemic treatment received), in order to describe the basal immune response of patients treated for a breast cancer according to the stage… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesFrance
- Study dates
- 26 May 2020to 26 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman aged between 18 and 85.
- Patient with histologically proven infiltrating breast cancer.
- Triple negative breast cancer or RH + / HER2- (OR and RP <10% and HER2 negative (0 or 1+ in IHC or 2+ in IHC and FISH negative)
- Patient receiving treatment corresponding to one of these cohorts:
- In a metastatic situation with establishment of treatment with Paclitaxel regardless of the treatment line
- In a metastatic situation with establishment of treatment with Epirubicin - cyclophosphamide (EC) regardless of the treatment line
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- In a metastatic situation with establishment of treatment with Eribulin regardless of the line of treatment
- In a 1st line metastatic situation with initiation of treatment with Palbociclib or Abemaciclib, or Ribociclib in combination with hormone therapy (aromatase inhibitor)
- Patient who signed the informed consent for the study.
- Patient fit and able to adhere to protocol for the duration of the study, including visits, scheduled specimens and follow-up.
- Patient affiliated to the social security system.
Who cannot join
- Patient unable to understand, read and / or sign informed consent.
- Presence of cerebral or meningeal metastasis
- Current or previous use of an immunosuppressive drug in the 14 days preceding inclusion (except intranasal corticosteroids, systemic corticosteroids at physiological doses not exceeding 10 mg per day of prednisone or its equivalent, corticosteroids for antiemetic purposes, corticosteroids used as premedication for hypersensitivity reactions (injected CT scan, taxanes, etc.)
- Patient participating in another research that may modify the systemic treatment administered in the framework of the cohort in which she will be included.
- Pregnant or breastfeeding woman.
- HIV and / or HBV and / or HCV serology positive.
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- Life expectancy estimated at less than 3 months.
- Patient's refusal.
- Person benefiting from a protection system for adults (including tutorship and curatorship).
- Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Emilie REDERSTORFF contact
France2 sites, 2 recruiting
- Not yet recruiting
CHRU Jean Minjoz
Besançon, 25000
Fernando BAZAN, 03 70 63 24 03, fbazan@chu-besancon.fr
- Recruiting
Centre Georges Francois Leclerc
Dijon, 21079
Sylvain LADOIRE, PU-PH, 03 80 73 75 28, sladoire@cgfl.fr
About this study
This study aims to constitute a most complete biological collection for patients treated for localized or metastatic breast cancer (in different cohorts depending on the type of systemic treatment received), in order to describe the basal immune response of patients treated for a breast cancer according to the stage of the disease, but above all to study how the different systemic treatments used in the management of breast cancer modulate this immune response.
Read the detailed description
The main objective of this study is to describe, depending on the type of systemic treatment received, the blood immune response before treatment and its evolution under treatment.
- Conditions
- Breast Cancer
- Being tested
- blood sample
- Keywords
- immune response, blood samples
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
•Blood sample:
- 1 heparinized tube (4 mL) for collection of plasma and storage
- 1 heparinized tube (4 mL) for immunophenotyping,
- 4 EDTA tubes (4 x 10 mL) for collecting white blood cells (PBMC) for cryopreservation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 4 différents cohorts:
* Paclitaxel cohort (N=30)
* Epirubicine - cyclophosphamide cohort (N=30)
* Eribuline cohort (N=30)
* Palbociclib (N=20) ou Abemaciclib (N=20) ou Ribociclib cohort (N=21)
Study diagram :
* Inclusion and screening visite
* Visit 1: J1C1
* Visit 2 : J8C1 to Paclitaxel cohort / Epirubicine - cyclophosphamide cohort / Eribuline cohort and J15C1 to Palbociclib ou Abemaciclib ou Ribociclib cohort
* Visit 3 :J21C1
* Visit 4 : J8C3 to Paclitaxel cohort / Epirubicine - cyclophosphamide cohort / Eribuline cohort and J15C3 to Palbociclib ou Abemaciclib ou Ribociclib cohort
During these visits, we collect, before the start of treatment administration ;
* Vital signs,
* Concomitant treatments,
* Blood sample:
* 1 heparinized tube (4 mL) for collection of plasma and storage
* 1 heparinized tube (4 mL) for immunophenotyping,
* 4 EDTA tubes (4 x 10 mL) for collecting white blood cells (PBMC) for cryopreservation. Receives: Other: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood immune response blood immune response blood immune response
realization of a plasma library, immunophenotyping and a PBMC bank
realization of a plasma library, immunophenotyping and a PBMC bank
realization of a plasma library, immunophenotyping and a PBMC bank
realization of a plasma library, immunophenotyping and a PBMC bank
realization of a plasma library, immunophenotyping and a PBMC bank
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start26 May 2020
- Primary completion26 May 2030 (estimated)
- Study completion26 May 2030 (estimated)
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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain LADOIRE, PU-PH, Principal investigator, Centre Georges François Leclerc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925856
- Sponsor's protocol ID
- 2019-A02195-52
- Acronym
- IMMUNE CAPTURE
- Status last verified
- Oct 2023
- First submitted
- 8 Jun 2021
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomonitoring of Breast Cancer Patients During Systemic Treatment
- ClinicalTrials.gov ID
- NCT04925856
- Acronym / sponsor ID
- IMMUNE CAPTURE / 2019-A02195-52
- Conditions
- Breast Cancer
- Keywords
- immune response, blood samples
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 26 May 2020 (actual)
- Primary completion
- 26 May 2030 (estimated)
- Study completion
- 26 May 2030 (estimated)
- First posted
- 14 Jun 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.
This study aims to constitute a most complete biological collection for patients treated for localized or metastatic breast cancer (in different cohorts depending on the type of systemic treatment received), in order to describe the basal immune response of patients treated for a breast cancer according to the stage of the disease, but above all to study how the different systemic treatments used in the management of breast cancer modulate this immune response.
Detailed description
The main objective of this study is to describe, depending on the type of systemic treatment received, the blood immune response before treatment and its evolution under treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: blood sample4 différents cohorts: * Paclitaxel cohort (N=30) * Epirubicine - cyclophosphamide cohort (N=30) * Eribuline cohort (N=30) * Palbociclib (N=20) ou Abemaciclib (N=20) ou Ribociclib cohort (N=21) Study diagram : * Inclusion and screening visite * Visit 1: J1C1 * Visit 2 : J8C1 to Paclitaxel cohort / Epirubicine - cyclophosphamide cohort / Eribuline cohort and J15C1 to Palbociclib ou Abemaciclib ou Ribociclib cohort * Visit 3 :J21C1 * Visit 4 : J8C3 to Paclitaxel cohort / Epirubicine - cyclophosphamide cohort / Eribuline cohort and J15C3 to Palbociclib ou Abemaciclib ou Ribociclib cohort During these visits, we collect, before the start of treatment administration ; * Vital signs, * Concomitant treatments, * Blood sample: * 1 heparinized tube (4 mL) for collection of plasma and storage * 1 heparinized tube (4 mL) for immunophenotyping, * 4 EDTA tubes (4 x 10 mL) for collecting white blood cells (PBMC) for cryopreservation. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Woman aged between 18 and 85.
- Patient with histologically proven infiltrating breast cancer.
- Triple negative breast cancer or RH + / HER2- (OR and RP <10% and HER2 negative (0 or 1+ in IHC or 2+ in IHC and FISH negative)
- Patient receiving treatment corresponding to one of these cohorts:
- Patient who signed the informed consent for the study.
Key exclusion criteria (10 listed)
- Patient unable to understand, read and / or sign informed consent.
- Presence of cerebral or meningeal metastasis
- Current or previous use of an immunosuppressive drug in the 14 days preceding inclusion (except intranasal corticosteroids, systemic corticosteroids at physiological doses not exceeding 10 mg per day of prednisone or its equivalent, corticosteroids for antiemetic purposes, corticosteroids used as premedication for hypersensitivity reactions (injected CT scan, taxanes, etc.)
- Patient participating in another research that may modify the systemic treatment administered in the framework of the cohort in which she will be included.
- Pregnant or breastfeeding woman.
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 |
|---|---|---|
| blood sample•Blood sample: * 1 heparinized tube (4 mL) for collection of plasma and storage * 1 heparinized tube (4 mL) for immunophenotyping, * 4 EDTA tubes (4 x 10 mL) for collecting white blood cells (PBMC) for cryopreservation. | Other | Experimental |
Primary outcome
blood immune response blood immune response blood immune response
Time frame: 24 months
realization of a plasma library, immunophenotyping and a PBMC bank realization of a plasma library, immunophenotyping and a PBMC bank realization of a plasma library, immunophenotyping and a PBMC bank realization of a plasma library, immunophenotyping and a PBMC bank realization of a plasma library, immunophenotyping and a PBMC bank
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
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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.
Emilie REDERSTORFF contact
Sylvain LADOIRE, PU-PH principal investigator
Centre Georges François Leclerc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample in people with Breast Cancer, run by Centre Georges Francois Leclerc at 2 sites 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 11 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvain LADOIRE, PU-PH (03 80 73 75 28, sladoire@cgfl.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood immune response blood immune response blood immune response (time frame: 24 months). 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 17 Oct 2023.