Immunomonitoring of Breast Cancer Patients During Systemic Treatment
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-85
SponsorCentre Georges Francois Leclerc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
In a metastatic situation with establishment of treatment with Paclitaxel regardless of the treatment line
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
blood sample
Other intervention•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.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: ExperimentalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
24 monthsSponsors and contacts
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Source ClinicalTrials.gov