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

March 23, 2020 updated by: Centre Leon Berard

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • DIJON Cedex, France, 21079
        • Centre Georges Francois Leclerc
      • LYON Cedex 08, France, 69373
        • Centre Leon Berard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Day (D) 1 chemotherapy (CT) n°1, D1 CT n°3, Surgery, 6 month post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
D1 CT n°1, D1 CT n°3, Surgery, 6 month post surgery
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)
D1 CT n°1, D1 CT n°3, Surgery, 6 month post surgery
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
At the end of the study (5 years of follow-up)
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
At the end of the study (5 years of follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2011

Primary Completion (Actual)

December 1, 2018

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

September 14, 2011

First Submitted That Met QC Criteria

September 23, 2011

First Posted (Estimate)

September 26, 2011

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BREAST IMMUN
  • ET11-059 (Other Identifier: Sponsor identification)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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