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

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Determine the correlation between histopathological response (pCR) and induction of tumor immunity in response to neoadjuvant chemotherapy

Outcome Description:

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).

Outcome Time Frame:

Day (D) 1 chemotherapy (CT) n°1, D1 CT n°3, Surgery, 6 month post surgery

Safety Issue:


Principal Investigator

Olivier TREDAN, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Leon Berard


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

December 2011

Completion Date:

December 2018

Related Keywords:

  • Breast Cancer
  • anti-tumor immune response
  • neo-adjuvant chemotherapy
  • relapse
  • long term survival
  • histo-pathological response
  • tumor cell death
  • tumor associated antigens
  • Calreticulin
  • Localized breast cancer
  • Breast Neoplasms