NCT00645866已完成2 期
A Neo-Adjuvant Study of Sequential Epirubicin and Docetaxel in Combination With Capecitabine in Patients With Locally Advanced Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 47
- 主要终点
- Toxicity patterns
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as epirubicin, docetaxel, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving epirubicin together with docetaxel and capecitabine and to see how well it works in treating women with stage IIIA or stage IIIB breast cancer.
详细描述
OBJECTIVES:
Primary
- Describe the pathologic response rate in chemotherapy-naive women with locally advanced breast cancer (stage IIIA or IIIB) after 6 courses of sequential neoadjuvant therapy with epirubicin hydrochloride and a combination of docetaxel with capecitabine .
- Describe the adverse events of sequential epirubicin hydrochloride and a combination of docetaxel with capecitabine in this patient population.
Secondary
- Identify by transcriptional profiling the differential expression of candidate gene products that confer chemosensitivity to epirubicin hydrochloride, docetaxel, and capecitabine.
- Correlate the differential expression of known genetic polymorphisms of intracellular regulators involved in the metabolism of epirubicin hydrochloride, docetaxel, and capecitabine with adverse events and tumor response.
- Assess individual patient variation in clinical (toxicity and/or activity), in pharmacologic (pharmacokinetic/pharmacodynamic parameters), and/or biologic (correlative laboratory study results) responses to epirubicin hydrochloride, docetaxel, and capecitabine due to genetic differences in proteins involved in drug response (transport, metabolism and/or mechanism of action).
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed breast cancer
- •Stage IIIA or IIIB disease (T3 N1 M0, T4 N1 M0, any T N2/N3 M0)
- •Bidimensionally measurable or evaluable disease
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status not specified
- •ECOG performance status 0-2
- •Platelet count ≥ 100,000 cells/μL
- •Total bilirubin normal
- •Hemoglobin ≥ 8.0 g/dL
- •ANC ≥ 1,000 cells/μL
- •AST and ALT ≤ 2.5 times upper limit of normal
- •Creatinine clearance ≥ 50 mL/min and serum creatinine normal
- •Life expectancy ≥ 3 months
- •No uncontrolled infection
- •No chronic debilitating disease
- •No lack of physical integrity of the upper gastrointestinal tract
- •Able to swallow tablets
- •No malabsorption syndrome
- •No clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias [New York Heart Association class III-IV heart disease] or myocardial infarction within the last 12 months)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer or adequately treated other noninvasive carcinomas
- •No peripheral neuropathy ≥ grade 1
- •PRIOR CONCURRENT THERAPY:
- •More than 4 weeks since prior major surgery and recovered
- •No prior chemotherapy regimens including adjuvant therapy
- •No organ allograft
- •No concurrent sorivudine or bruvidine
- •No other concurrent cytostatic, cytotoxic, immunomodulating agents, or radiotherapy
排除标准
- 未提供
结局指标
主要结局
Toxicity patterns
Pathologic response rate
次要结局
- Overall survival
研究者
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