Study of the Response to a Neoadjuvant Chemotherapy Based on the Antitumor Immune Response in Localized Breast Cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Centre Leon Berard
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Determine the correlation between histopathological response (pCR) and induction of tumor immunity in response to neoadjuvant chemotherapy
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically proven localized breast cancer required anthracycline chemotherapy +/- trastuzumab before surgery
- •Age \> 18 years
- •Chemotherapy with 3 anthracycline cycles to begin (doxorubicin or epirubicin)
- •Any previous treatment for this cancer
- •Performance Status \<= 1
- •Agreement for the conservation of biological samples
- •Covered by an medical insurance
- •Signed written informed consent form
- •Availability of tumoral sample collected at diagnosis
Exclusion Criteria
- •Previous surgery for the breast cancer
- •Already under chemotherapy before the first blood sample
- •Previous Antitumoral treatment
- •Under immunosuppressive treatment
- •Under corticoids during the 15 days before enrollment
- •History of concomitant cancer except if it has been cured for at least 5 years
- •History of lymphoma or breast sarcoma
- •History of chronic inflammatory disease or autoimmune disease, hepatitis B or C or immune dysfunction disease (including HIV-positive stage AIDS) known
- •History of other disease which is discrepant with this study
- •Deprived of liberty by court or administrative decision
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Evolution of the immune profile during management of localized breast cancer(D1 CT n°1, D1 CT n°3, Surgery, 6 month post surgery)
- Analysis of genetic polymorphisms(D1 CT n°1, D1 CT n°3, Surgery, 6 month post surgery)
- Determination of relapse risk based on biological characteristics identified(At the end of the study (5 years of follow-up))
- Determining the risk of death based on biological characteristics identified(At the end of the study (5 years of follow-up))