Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment blood and tumor sample
Sponsor Centre Leon Berard
Start date December 2011
End date December 2018
Trial size 40 participants
Trial identifier NCT01440413, BREAST IMMUN, ET11-059

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label

Primary Outcomes

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

Secondary Outcomes

Measure
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 of genetic polymorphisms
time frame: 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)
Determining the risk of death based on biological characteristics identified
time frame: At the end of the study (5 years of follow-up)

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Study of the Response to a Neoadjuvant Chemotherapy Based on the Antitumor Immune Response in Localized Breast Cancer
Principal investigator Olivier TREDAN, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Centre Leon Berard.