Immunomonitoring of Breast Cancer Patients During Systemic Treatment
IMMUNE CAPTURE
1 other identifier
interventional
150
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started May 2020
Longer than P75 for not_applicable breast-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 26, 2020
CompletedFirst Submitted
Initial submission to the registry
June 8, 2021
CompletedFirst Posted
Study publicly available on registry
June 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 26, 2030
October 17, 2023
October 1, 2023
10 years
June 8, 2021
October 16, 2023
Conditions
Keywords
Outcome Measures
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
24 months
Study Arms (1)
Experimental
EXPERIMENTAL4 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.
Interventions
•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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patient unable to understand, read and / or sign informed consent.
- Presence of cerebral or meningeal metastasis
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHRU Jean Minjoz
Besançon, 25000, France
Centre Georges Francois Leclerc
Dijon, 21079, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sylvain LADOIRE, PU-PH
Centre Georges François Leclerc
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2021
First Posted
June 14, 2021
Study Start
May 26, 2020
Primary Completion (Estimated)
May 26, 2030
Study Completion (Estimated)
May 26, 2030
Last Updated
October 17, 2023
Record last verified: 2023-10