Status:
UNKNOWN
Study of the Response to a Neoadjuvant Chemotherapy Based on the Antitumor Immune Response in Localized Breast Cancer
Lead Sponsor:
Centre Leon Berard
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01440413
Start Date
December 1 2011
End Date
December 1 2020
Last Update
March 24 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Georges François Leclerc
Dijon, France, 21079
2
Centre Leon Berard
Lyon, France, 69373