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Immunomonitoring of Breast Cancer Patients During Systemic Treatment (IMMUNE CAPTURE)

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
Sponsored by
Centre Georges Francois Leclerc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring immune response, blood samples

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Woman aged between 18 and 85.
  2. Patient with histologically proven infiltrating breast cancer.
  3. 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)

  4. 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
    • 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)
  5. Patient who signed the informed consent for the study.
  6. Patient fit and able to adhere to protocol for the duration of the study, including visits, scheduled specimens and follow-up.
  7. Patient affiliated to the social security system.

Exclusion Criteria:

  1. Patient unable to understand, read and / or sign informed consent.
  2. Presence of cerebral or meningeal metastasis
  3. 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.)
  4. Patient participating in another research that may modify the systemic treatment administered in the framework of the cohort in which she will be included.
  5. Pregnant or breastfeeding woman.
  6. HIV and / or HBV and / or HCV serology positive.
  7. Life expectancy estimated at less than 3 months.
  8. Patient's refusal.
  9. Person benefiting from a protection system for adults (including tutorship and curatorship).
  10. Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.

Sites / Locations

  • CHRU Jean Minjoz
  • Centre Georges Francois LeclercRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 8, 2021
Last Updated
October 16, 2023
Sponsor
Centre Georges Francois Leclerc
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1. Study Identification

Unique Protocol Identification Number
NCT04925856
Brief Title
Immunomonitoring of Breast Cancer Patients During Systemic Treatment
Acronym
IMMUNE CAPTURE
Official Title
Immunomonitoring of Breast Cancer Patients During Systemic Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2020 (Actual)
Primary Completion Date
May 26, 2030 (Anticipated)
Study Completion Date
May 26, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Georges Francois Leclerc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
immune response, blood samples

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
blood sample
Intervention Description
•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.
Primary Outcome Measure Information:
Title
blood immune response blood immune response blood immune response
Description
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
Time Frame
24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvain LADOIRE, PU-PH
Phone
03 80 73 75 28
Email
sladoire@cgfl.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie REDERSTORFF
Email
erederstorff@cgfl.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvain LADOIRE, PU-PH
Organizational Affiliation
Centre Georges François Leclerc
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Jean Minjoz
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando BAZAN
Phone
03 70 63 24 03
Email
fbazan@chu-besancon.fr
Facility Name
Centre Georges Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain LADOIRE, PU-PH
Phone
03 80 73 75 28
Email
sladoire@cgfl.fr

12. IPD Sharing Statement

Learn more about this trial

Immunomonitoring of Breast Cancer Patients During Systemic Treatment

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