Immunomonitoring of Breast Cancer Patients During Systemic Treatment

Breast Cancer Clinical Trial

— IMMUNE CAPTURE  

Official title:

Immunomonitoring of Breast Cancer Patients During Systemic Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04925856
• Other study ID #: 2019-A02195-52
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2020
• Est. completion date: May 26, 2030

Study information

• Verified date: October 2023
• Source: Centre Georges Francois Leclerc
• Contact: Sylvain LADOIRE, PU-PH
• Phone: 03 80 73 75 28
• Email: sladoire[@]cgfl.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 of the disease, but above all to study how the different systemic treatments used in the management of breast cancer modulate this immune response.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 26, 2030
• Est. primary completion date: May 26, 2030
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	CHRU Jean Minjoz	Besançon
France	Centre Georges Francois Leclerc	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Georges Francois Leclerc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 months