Clinical trial NCT01440413: Study of the Response to a Neoadjuvant Chemotherapy Based on the Antitumor Immune Response in Localized Breast Cancer
Official title: Study of the Response to a Neoadjuvant Chemotherapy Based on the Antitumor Immune Response in Localized Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: anti-tumor immune response
neo-adjuvant chemotherapy
relapse
long term survival
histo-pathological response
tumor cell death
tumor associated antigens
Calreticulin
Localized breast cancer
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2011-09-26
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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
* Pregnant or breastfeeding women or with no use of effective birth control methods for women of childbearing potential

Primary outcomes:
measure: Determine the correlation between histopathological response (pCR) and induction of tumor immunity in response to neoadjuvant chemotherapy
timeFrame: Day (D) 1 chemotherapy (CT) n°1, D1 CT n°3, Surgery, 6 month post surgery
Secondary outcomes:
measure: Evolution of the immune profile during management of localized breast cancer
timeFrame: D1 CT n°1, D1 CT n°3, Surgery, 6 month post surgery
measure: Analysis of genetic polymorphisms
timeFrame: D1 CT n°1, D1 CT n°3, Surgery, 6 month post surgery
measure: Determination of relapse risk based on biological characteristics identified
timeFrame: At the end of the study (5 years of follow-up)
measure: Determining the risk of death based on biological characteristics identified
timeFrame: At the end of the study (5 years of follow-up)
Other outcomes:
Locations:
city: DIJON Cedex
country: France
facility: Centre Georges François Leclerc
city: LYON Cedex 08
country: France
facility: Centre Leon Berard
Study officials:
affiliation: Centre Leon Berard
name: Olivier TREDAN, MD
role: PRINCIPAL_INVESTIGATOR
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