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

October 16, 2023 updated by: Centre Georges Francois Leclerc
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Sylvain LADOIRE, PU-PH
  • Phone Number: 03 80 73 75 28
  • Email: sladoire@cgfl.fr

Study Locations

  • France
      • Besançon, France, 25000
        • Not yet recruiting
        • CHRU Jean Minjoz
        • Contact:
      • Dijon, France, 21079
        • Recruiting
        • Centre Georges Francois Leclerc
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Georges Francois Leclerc

Investigators

  • Principal Investigator: Sylvain LADOIRE, PU-PH, Centre Georges Francois Leclerc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2020

Primary Completion (Estimated)

May 26, 2030

Study Completion (Estimated)

May 26, 2030

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

June 8, 2021

First Posted (Actual)

June 14, 2021

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A02195-52

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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