Randomized Trial Comparing Standard Neoadjuvant Chemotherapy to Genomic Driven Chemotherapy Regimen in Patients With Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 1
- 主要终点
- Complete response rate based on the histology
研究概览
简要总结
This randomized trial is comparing a standard neoadjuvant chemotherapy with a genomic driven chemotherapy in patients with breast cancer.
详细描述
After a core biopsy, each tumor is profiled using Affymetrix U133plus2 gene expression array. DLD30 score (Hess, JCO, 2006) and TOP2A expression are quantified. Patients are then either treated with 4FEC followed by 4 docetaxel (standard arm) or by a genomic-driven regimen (experiemental arm). In the experimental arm, patients with high DLD30 receive 3 months weekly paclitaxel followed by 4 FEC, patients with high TOP2A receive 4FEC then 4 docetaxel, patients with low DLD30 and low TOP2A are treated with 6 cycles of docetaxel-capecitabine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 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
- •Invasive breast cancer not eligible for conservative surgery
- •Her2 negative
- •Amount of tumor cells >30% on HES slides
- •RIN>6 and amount of RNA>1 ug
- •No metastases
- •Subject, age > 18 years and <65 years old
- •Signed written informed consent
- •No previous treatment for breast cancer
- •Adequate organ function
- •FEVG >50%
排除标准
- •In situ carcinoma
- •Multifocal cancers
- •Presence of metastasis
- •Genomic testing not feasible because of tumor cells <30%, RIN<6, insufficient amount of RNA
- •Organ dysfunction that contraindicates chemotherapy
研究组 & 干预措施
Genomic driven chemotherapy
High DLD30 receive 3 months weekly paclitaxel followed by 4 FEC, patients with high TOP2A receive 4FEC then 4 docetaxel, patients with low DLD30 and low TOP2A are treated with 6 cycles of docetaxel-capecitabine.
干预措施: Genomic driven chemotherapy (Drug)
Chemotherapy
4 cycles FEC followed by 4 cycles docetaxel
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Complete response rate based on the histology
时间窗: Tumoral assessment at 4 and 8 cycles
次要结局
未报告次要终点