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

NCT01440413 | Unknown

• 2 other identifiers: BREAST IMMUNET11-059
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

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

Outcome Measures

Primary Outcomes (1)

• Determine the correlation between histopathological response (pCR) and induction of tumor immunity in response to neoadjuvant chemotherapy

  Rate of histopathologic response (IHC). Analysis of lymphocyte subpopulations (whole blood - flow cytometry). Analysis of the frequency of immune cells, the phenotype and functional status on the site of the tumor (fixed tissue - IHC). Analysis of the functional status of sub-populations of DC and lymphocytes of innate immunity (fresh whole blood - flow cytometry). Analysis of BCR and TCR repertoires (mononuclear cells - PCR). Identification of TAA expressed by the tumor (plasma, tumor - ELISA, IHC).Analysis of the humoral response against TAA (plasma - ELISA).

  Day (D) 1 chemotherapy (CT) n°1, D1 CT n°3, Surgery, 6 month post surgery

Secondary Outcomes (4)

• Evolution of the immune profile during management of localized breast cancer

  D1 CT n°1, D1 CT n°3, Surgery, 6 month post surgery

• Analysis of genetic polymorphisms

  D1 CT n°1, D1 CT n°3, Surgery, 6 month post surgery

• Determination of relapse risk based on biological characteristics identified

  At the end of the study (5 years of follow-up)

• Determining the risk of death based on biological characteristics identified

  At the end of the study (5 years of follow-up)

Interventions

Blood and tumor sample BIOLOGICAL

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (2)

Centre Georges François Leclerc

Dijon, 21079, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Related Publications (24)

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MeSH Terms

Conditions

Breast Neoplasms; Recurrence

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Olivier TREDAN, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: September 26, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2020
• Last Updated: March 24, 2020

Record last verified: 2020-03

Locations

FR (2)