Study of the Response to a Neoadjuvant Chemotherapy Based on the Antitumor Immune Response in Localized Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Determine the correlation between histopathological response (pCR) and induction of tumor immunity in response to neoadjuvant chemotherapy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Determine the correlation between histopathological response (pCR) and induction of tumor immunity in response to neoadjuvant chemotherapy
时间窗: Day (D) 1 chemotherapy (CT) n°1, D1 CT n°3, Surgery, 6 month post surgery
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).
次要结局
- 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))