Immunomonitoring of Breast Cancer Patients During Systemic Treatment

NCT ID: NCT04925856

Last Updated: 2023-10-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-26
• Study Completion Date: 2030-05-26

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

blood sample

Intervention Type: OTHER

•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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Georges Francois Leclerc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvain LADOIRE, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Centre Georges François Leclerc

Locations

CHRU Jean Minjoz

Besançon, , France

Site Status: NOT_YET_RECRUITING

Centre Georges Francois Leclerc

Dijon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Sylvain LADOIRE, PU-PH

Role: CONTACT

sladoire@cgfl.fr

03 80 73 75 28

Emilie REDERSTORFF

Role: CONTACT

erederstorff@cgfl.fr

Facility Contacts

Fernando BAZAN

Role: primary

fbazan@chu-besancon.fr

03 70 63 24 03

Sylvain LADOIRE, PU-PH

Role: primary

sladoire@cgfl.fr

03 80 73 75 28

Other Identifiers

2019-A02195-52

Identifier Type: -

Identifier Source: org_study_id