Ignite Creation Date:
2024-05-06 @ 2:36 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04368468
Status:
COMPLETED
Last Update Posted:
2022-12-23
First Post:
2020-04-20
Brief Title:
Modifications of Immune Microenvironment Induced by Neoadjuvant Chemotherapy in Triple-negative BC
Sponsor:
Institut Claudius Regaud
Organization:
Institut Claudius Regaud
Study Overview
Official Title:
Study of the Modifications of the Immune Microenvironment Induced by Neoadjuvant Chemotherapy in Triple-negative Breast Cancers
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIMOSA
Brief Summary:
The prescription of neoadjuvant chemotherapy becomes a standard in women with HER2-positive or triple-negative breast cancer and allows a complete histological response pCR which represents a prognostic factor for survival The problem for patients who are not pCR is that they are currently receiving non-personalized adjuvant systemic treatment
The identification of biomarkers present in the residual disease would be a criterion to guide the choice of post-neoadjuvant adjuvant systemic treatment in order to personalize it
At the present time there is no published study describing extensively the immune micro-environment ME in breast cancer whether before or after chemotherapy nor its modification induced by chemotherapy
The team therefore propose to study in a retrospective and monocentric series the modifications of the immune ME induced by a standard neo-adjuvant chemotherapy in patients with triple-negative CS whether they are in complete histological response or not n twice 50
The main objective of this project is to describe the changes in the immune ME of triple-negative breast cancers induced by neoadjuvant chemotherapy for all patients in pCR or not
Quantification of TILs and subtypes of TILs CD4 and CD8
Expression of the three immune checkpoints that are PDL1 TIM3 and LAG3
Describe the organization of the immune system immunostaining on the same slide of the PDL1 TIM3 and LAG3 immune checkpoints
The identification of biomarkers present in the residual disease would be a criterion to guide the choice of post-neoadjuvant adjuvant systemic treatment in order to personalize it
At the present time there is no published study describing extensively the immune micro-environment ME in breast cancer whether before or after chemotherapy nor its modification induced by chemotherapy
The team therefore propose to study in a retrospective and monocentric series the modifications of the immune ME induced by a standard neo-adjuvant chemotherapy in patients with triple-negative CS whether they are in complete histological response or not n twice 50
The main objective of this project is to describe the changes in the immune ME of triple-negative breast cancers induced by neoadjuvant chemotherapy for all patients in pCR or not
Quantification of TILs and subtypes of TILs CD4 and CD8
Expression of the three immune checkpoints that are PDL1 TIM3 and LAG3
Describe the organization of the immune system immunostaining on the same slide of the PDL1 TIM3 and LAG3 immune checkpoints
Detailed Description:
Retrospective and monocentric translational study carried out on patients treated at the IUCT-Oncopole by neoadjuvant chemotherapy sequential treatment FEC100 or EC100 then taxane paclitaxel weekly for the most part for a triple-negative CS between 2012 and 2018
We have the microbiopsy of the primary tumor preserved in FFPE and the operating room preserved in FFPE
We have all the clinical data for the diagnosis and monitoring of these patients already entered into a database
The search for a BRCA germline mutation is available in most patients if indicated for an oncogenetic consultation
biomarkers analysis
TILS account according to Salgado et al before and after neoadjuvant chemotherapy
IHC CK5-6 and EGFR then RA if the first two are negative to characterize triple negative tumors in basal-like and non-basal-like
IHC CD3 labeling of T lymphocytes
IHC CD4 CD8 and FOXP3 before and after neoadjuvant chemotherapy
PDL1 TIM3 and LAG3 multiplex IHC before and after neoadjuvant chemotherapy
Labeling of tumor cells AE1 AE3
Use of markings for exploratory analyzes CD68 macrophages CD39 marker of lymphocyte exhaust
We have the microbiopsy of the primary tumor preserved in FFPE and the operating room preserved in FFPE
We have all the clinical data for the diagnosis and monitoring of these patients already entered into a database
The search for a BRCA germline mutation is available in most patients if indicated for an oncogenetic consultation
biomarkers analysis
TILS account according to Salgado et al before and after neoadjuvant chemotherapy
IHC CK5-6 and EGFR then RA if the first two are negative to characterize triple negative tumors in basal-like and non-basal-like
IHC CD3 labeling of T lymphocytes
IHC CD4 CD8 and FOXP3 before and after neoadjuvant chemotherapy
PDL1 TIM3 and LAG3 multiplex IHC before and after neoadjuvant chemotherapy
Labeling of tumor cells AE1 AE3
Use of markings for exploratory analyzes CD68 macrophages CD39 marker of lymphocyte exhaust
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None