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NCT Number: NCT04925856

Immunomonitoring of Breast Cancer Patients During Systemic Treatment

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.

Recruiting

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Key information

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Jean Minjoz, Besançon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood sample

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.

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Emilie REDERSTORFF

CONTACT

[email protected]

Sylvain LADOIRE, PU-PH

CONTACT

[email protected]

03 80 73 75 28

Sponsors and collaborators

Lead sponsor

Centre Georges Francois Leclerc

Other

Registry information

Acronym: IMMUNE CAPTURE

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Jun 14, 2021
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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