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

Léon Bérard Center

Status: Unknown

Conditions: Breast Cancer

Treatments: Biological: Blood and tumor sample

Study type: Interventional

Funder types: Other

Identifiers

NCT01440413

ET11-059 (Other Identifier)

BREAST IMMUN

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)