Analysis of the Proteomic Signature in Breast Cancer Correlated With Tumor Response in Patients Necessitating a Neo-adjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 5
- 主要终点
- Proteomic analysis by SELDI-TOF on the tumor biopsy and blood samples Histological response according To Chevallier and Sataloff
研究概览
简要总结
The scope of the trial is to identify proteomic signatures correlated with tumor response to neo-adjuvant chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Women aged more than 18 years
- •Histologically proven breast carcinoma
- •Neo-adjuvant chemotherapy with anthracyclines and/or taxanes
- •No prior chemotherapy
- •Written informed consent
排除标准
- •Metastatic disease
研究组 & 干预措施
FEC 100 + TAXOTERE
FEC 100 = Fluoro-uracile + Epirubicin + Cyclophosphamide Fluoro-uracile : 500 mg/m²/cycle Epirubicin : 100 mg/m²/cycle Cyclophosphamide : 500 mg/m²/cyle 1 cycle = 21 days. For a total of 6 cycles or 3 cycles followed by 3 cycles of TAXOTERE
TAXOTERE 100 mg/m²/cycle
1 cycle = 21 days. For a total of 3 cycles following 3 FEC 100
干预措施: Blood sampling (Procedure)
FEC 100 + TAXOTERE
FEC 100 = Fluoro-uracile + Epirubicin + Cyclophosphamide Fluoro-uracile : 500 mg/m²/cycle Epirubicin : 100 mg/m²/cycle Cyclophosphamide : 500 mg/m²/cyle 1 cycle = 21 days. For a total of 6 cycles or 3 cycles followed by 3 cycles of TAXOTERE
TAXOTERE 100 mg/m²/cycle
1 cycle = 21 days. For a total of 3 cycles following 3 FEC 100
干预措施: BIOPSY (Procedure)
FEC 100 + TAXOTERE
FEC 100 = Fluoro-uracile + Epirubicin + Cyclophosphamide Fluoro-uracile : 500 mg/m²/cycle Epirubicin : 100 mg/m²/cycle Cyclophosphamide : 500 mg/m²/cyle 1 cycle = 21 days. For a total of 6 cycles or 3 cycles followed by 3 cycles of TAXOTERE
TAXOTERE 100 mg/m²/cycle
1 cycle = 21 days. For a total of 3 cycles following 3 FEC 100
干预措施: SURGERY (Procedure)
结局指标
主要结局
Proteomic analysis by SELDI-TOF on the tumor biopsy and blood samples Histological response according To Chevallier and Sataloff
时间窗: 6 months
次要结局
- Correlation with node invasion(6 months)
- Correlation with basal, luminal phenotypes, HER2 status or hormonal status(6 months)
- Correlation with the response measured by ultrasound after chemotherapy(After 3 and 5 months)