NCT00070278Unknown3 期
A Phase III Randomized Neoadjuvant Study of Sequential Epirubicin/Cyclophosphamide and Paclitaxel + - Gemcitabine in Poor Risk Early Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Complete pathological response after 4 courses
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, paclitaxel, and gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed during surgery. It is not yet known which combination chemotherapy regimen is more effective in treating early breast cancer.
PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating women who are undergoing surgery for early invasive breast cancer.
详细描述
OBJECTIVES:
Primary
- Compare the complete pathological response rate in women with poor-risk early breast cancer treated with neoadjuvant sequential epirubicin, cyclophosphamide, and paclitaxel with vs without gemcitabine.
Secondary
- Compare the disease-free and overall survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the effect of these regimens on prognostic factors in these patients.
- Correlate molecular profiles, specific gene mutations, and genomic and gene expression changes with clinical outcome in these patients.
- Compare the quality of life of patients treated with these regimens.
- Determine the health economics associated with this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed invasive breast cancer
- •Grade 2 or 3
- •Tumor size at least 3 cm by ultrasound
- •No evidence of metastatic disease
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Menopausal status
- •Not specified
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Fit to receive study chemotherapy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Complete pathological response after 4 courses
次要结局
- Survival
- Disease-free survival
- Effect of prognostic factors
研究者
研究点 (2)
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