First Prospective Intergroup Translational Research Trial Assessing the Potential Predictive Value of p53 Using a Functional Assay in Yeast in Patients With Locally Advanced/Inflammatory or Large Operable Breast Cancer Prospectively Randomised to a Taxane Versus a Non Taxane Regimen
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,856
- 试验地点
- 39
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Currently patients with breast cancer are treated with one of several very similar combinations of drugs. Analysis of biomarkers in tumor tissue may help doctors predict how well patients with breast cancer will respond to treatment and help doctors choose the best drug regimen to treat each patient.
PURPOSE: This randomized phase III trial is studying giving different regimens of chemotherapy and comparing how well they work in treating women with large operable or locally advanced or inflammatory breast cancer. This study is also looking at whether analyzing a specific biomarker (p53) in tumor tissue may help doctors predict how well patients will respond to treatment and help doctors choose the best drug to treat each patient.
详细描述
OBJECTIVES:
Primary
- Compare neoadjuvant fluorouracil, epirubicin, and cyclophosphamide vs docetaxel and epirubicin followed by radiotherapy and surgery in women with locally advanced, inflammatory, or large operable breast cancer.
- Assess overall differences between the two arms.
- Assess interaction between p53 status and outcomes in each arm.
- Compare the progression-free survival of patients treated with these regimens.
Secondary
- Compare the distant metastasis-free survival and survival of patients treated with these regimens.
- Compare the clinical and pathological responses to these regimens in these patients.
- Compare the toxicity of these regimens in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
taxane based chemotherapy
Docetaxel for 3 cycles followed by Epirubicin/Docetaxel for 3 cycles
干预措施: biopsy (Procedure)
non taxane based chemotherapy
either FEC 100 or Canadian CEF or Tailored FEC for 6 cycles
干预措施: neoadjuvant therapy (Procedure)
non taxane based chemotherapy
either FEC 100 or Canadian CEF or Tailored FEC for 6 cycles
干预措施: filgrastim (Biological)
non taxane based chemotherapy
either FEC 100 or Canadian CEF or Tailored FEC for 6 cycles
干预措施: cyclophosphamide (Drug)
non taxane based chemotherapy
either FEC 100 or Canadian CEF or Tailored FEC for 6 cycles
干预措施: epirubicin hydrochloride (Drug)
non taxane based chemotherapy
either FEC 100 or Canadian CEF or Tailored FEC for 6 cycles
干预措施: fluorouracil (Drug)
non taxane based chemotherapy
either FEC 100 or Canadian CEF or Tailored FEC for 6 cycles
干预措施: microarray analysis (Genetic)
non taxane based chemotherapy
either FEC 100 or Canadian CEF or Tailored FEC for 6 cycles
干预措施: immunohistochemistry staining method (Other)
non taxane based chemotherapy
either FEC 100 or Canadian CEF or Tailored FEC for 6 cycles
干预措施: laboratory biomarker analysis (Other)
non taxane based chemotherapy
either FEC 100 or Canadian CEF or Tailored FEC for 6 cycles
干预措施: biopsy (Procedure)
non taxane based chemotherapy
either FEC 100 or Canadian CEF or Tailored FEC for 6 cycles
干预措施: conventional surgery (Procedure)
non taxane based chemotherapy
either FEC 100 or Canadian CEF or Tailored FEC for 6 cycles
干预措施: radiation therapy (Radiation)
taxane based chemotherapy
Docetaxel for 3 cycles followed by Epirubicin/Docetaxel for 3 cycles
干预措施: docetaxel (Drug)
taxane based chemotherapy
Docetaxel for 3 cycles followed by Epirubicin/Docetaxel for 3 cycles
干预措施: epirubicin hydrochloride (Drug)
taxane based chemotherapy
Docetaxel for 3 cycles followed by Epirubicin/Docetaxel for 3 cycles
干预措施: microarray analysis (Genetic)
taxane based chemotherapy
Docetaxel for 3 cycles followed by Epirubicin/Docetaxel for 3 cycles
干预措施: immunohistochemistry staining method (Other)
taxane based chemotherapy
Docetaxel for 3 cycles followed by Epirubicin/Docetaxel for 3 cycles
干预措施: laboratory biomarker analysis (Other)
taxane based chemotherapy
Docetaxel for 3 cycles followed by Epirubicin/Docetaxel for 3 cycles
干预措施: conventional surgery (Procedure)
taxane based chemotherapy
Docetaxel for 3 cycles followed by Epirubicin/Docetaxel for 3 cycles
干预措施: neoadjuvant therapy (Procedure)
taxane based chemotherapy
Docetaxel for 3 cycles followed by Epirubicin/Docetaxel for 3 cycles
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Progression-free survival
时间窗: from randomization till first evidence of progression
次要结局
- Clinical response according to RECIST criteria without pathologic response(after 3rd and 6d cycle of chemotherapy)
- Toxicity according to CTC v2.0(from randomization)
- Agreement between p53 assessment by IHC method and functional test in yeast by analyzing the correlation between p52 and tumor status after 3 and 6 cycles of chemotherapy(after 3 and 6 cycles of chemotherapy)
- Tumor assessment using cDNA microarray technology(end of treatment)
- Distant metastasis-free survival(randomization till first evidence recurrence)
- Clinical and pathological responses(after 3rd and 6d cycle of chemotherapy)
- Overall survival(randomization till death)