Study of the Response to a Neoadjuvant Chemotherapy Based on the Antitumor Immune Response in Localized Breast Cancer (BREAST IMMUN)
|ClinicalTrials.gov Identifier: NCT01440413|
Recruitment Status : Active, not recruiting
First Posted : September 26, 2011
Last Update Posted : February 1, 2017
This is a prospective, non-randomized study which aims to evaluate the response to a neoadjuvant chemotherapy according to the the antitumor immune response in localized breast cancer.
40 patients will be enrolled in the study. They will receive chemotherapy : 3 or 4 anthracycline cycles or 3 or 4 FEC-100 cycles followed by 3 or 4 taxane cycles.
Trastuzumab will be added to taxane for HER2+/Neu+ patients. Then, patients will be operated and receive an adjuvant treatment which will both depend on the investigator's appreciation.
Blood sample will be collected on the first day of the first chemotherapy cycle, on the first day of the third cycle, on surgery, 6 months after the surgery and in case of relapse.
Tumor sample will be collected on diagnosis as much as possible and on surgery.
Patients will be followed during 5 years.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: Blood and tumor sample||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of the Response to a Neoadjuvant Chemotherapy Based on the Antitumor Immune Response in Localized Breast Cancer|
|Actual Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Biological: Blood and tumor sample
Blood samples will be collected on the first day of the first cycle of chemotherapy (before injection of chemotherapy), on the first day of the third cycle (before injection of chemotherapy), on day of surgery and 6 months after surgery and in case of relapse.
Tumor samples will be collected on diagnosis, on surgery and on the first day of the third chemotherapy course (optional).
- Determine the correlation between histopathological response (pCR) and induction of tumor immunity in response to neoadjuvant chemotherapy [ Time Frame: Day (D) 1 chemotherapy (CT) n°1, D1 CT n°3, Surgery, 6 month post surgery ]Rate of histopathologic response (IHC). Analysis of lymphocyte subpopulations (whole blood - flow cytometry). Analysis of the frequency of immune cells, the phenotype and functional status on the site of the tumor (fixed tissue - IHC). Analysis of the functional status of sub-populations of DC and lymphocytes of innate immunity (fresh whole blood - flow cytometry). Analysis of BCR and TCR repertoires (mononuclear cells - PCR). Identification of TAA expressed by the tumor (plasma, tumor - ELISA, IHC).Analysis of the humoral response against TAA (plasma - ELISA).
- Evolution of the immune profile during management of localized breast cancer [ Time Frame: D1 CT n°1, D1 CT n°3, Surgery, 6 month post surgery ]Analysis in plasma of the rate of apoptotic tumor cells, of TAA (CEA and MUC1 ELISA), of tumor DNA and endogenous ligands of TLR (HMGB1 ELISA) Assay of cytokines and chemokines in plasma Analysis of the expression of proteins involved in the translocation of CRT to the cell surface (fixed-frozen tissue - IHC or immunoblotting) Analysis on the tumor (IHC or immunoblotting) of degradation of BAP31, activation of caspase 8/Bax/Bak, phosphorylation of eIF2 and exposure of surface CRT, KDEL receptor and ERp57
- Analysis of genetic polymorphisms [ Time Frame: D1 CT n°1, D1 CT n°3, Surgery, 6 month post surgery ]Analysis of P2X7 and TLR4 polymorphisms on circulating cells (plasma)
- Determination of relapse risk based on biological characteristics identified [ Time Frame: At the end of the study (5 years of follow-up) ]Progression-free survival
- Determining the risk of death based on biological characteristics identified [ Time Frame: At the end of the study (5 years of follow-up) ]Overall survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440413
|Centre Georges François Leclerc|
|DIJON Cedex, France, 21079|
|Centre Leon Berard|
|LYON Cedex 08, France, 69373|
|Principal Investigator:||Olivier TREDAN, MD||Centre Leon Berard|