Immunomonitoring of Breast Cancer Patients During Systemic Treatment (IMMUNE CAPTURE)
Breast Cancer
About this trial
This is an interventional other trial for Breast Cancer focused on measuring immune response, blood samples
Eligibility Criteria
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.
Sites / Locations
- CHRU Jean Minjoz
- Centre Georges Francois LeclercRecruiting
Arms of the Study
Arm 1
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.