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

NCT ID: NCT01440413

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2020-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

Blood and tumor sample

Blood samples will be collected on the first day of the first cycle of chemotherapy (before injection of chemotherapy), on the first day of the third cycle (before injection of chemotherapy), on day of surgery and 6 months after surgery and in case of relapse.

Tumor samples will be collected on diagnosis, on surgery and on the first day of the third chemotherapy course (optional).

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier TREDAN, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Leon Berard

Locations

Centre Georges François Leclerc

Dijon, , France

Centre Leon Berard

Lyon, , France

Countries

France

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Other Identifiers

ET11-059

Identifier Type: OTHER

Identifier Source: secondary_id

BREAST IMMUN

Identifier Type: -

Identifier Source: org_study_id