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Study of the Response to a Neoadjuvant Chemotherapy Based on the Antitumor Immune Response in Localized Breast Cancer (BREAST IMMUN)

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ClinicalTrials.gov Identifier: NCT01440413
Recruitment Status : Active, not recruiting
First Posted : September 26, 2011
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard

September 14, 2011
September 26, 2011
February 1, 2017
December 2011
December 2018   (Final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01440413 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Study of the Response to a Neoadjuvant Chemotherapy Based on the Antitumor Immune Response in Localized Breast Cancer
Study of the Response to a Neoadjuvant Chemotherapy Based on the Antitumor Immune Response in Localized Breast Cancer

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.

Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Breast Cancer
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).

Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
Same as current
December 2018
December 2018   (Final data collection date for primary outcome measure)

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
  • Pregnant or breastfeeding women or with no use of effective birth control methods for women of childbearing potential
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01440413
BREAST IMMUN
ET11-059 ( Other Identifier: Sponsor identification )
No
Not Provided
Not Provided
Centre Leon Berard
Centre Leon Berard
Not Provided
Principal Investigator: Olivier TREDAN, MD Centre Leon Berard
Centre Leon Berard
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP