NCT00397761撤回2 期
Combination Capecitabine (Xeloda) and ABI-007 (Abraxane, Nanoparticle Albumin-Bound Paclitaxel) Chemotherapy as Neoadjuvant Treatment of Locally Advanced, Operable Breast Cancer
Medstar Health Research Institute1 个研究点 分布在 1 个国家开始时间: 2006年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Pathological complete response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as capecitabine and paclitaxel (albumin-stablized nanoparticle formulation, 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) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II/III trial is studying how well giving capecitabine together with paclitaxel (albumin-stabilized nanoparticle formulation) works in treating women undergoing surgery for stage II or stage III breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the rate of pathological complete response (i.e., tumor completely gone) in women with previously untreated, unresected, stage II-IIIB breast cancer treated with neoadjuvant therapy comprising capecitabine and paclitaxel (albumin-stabilized nanoparticle formulation) (Abraxane^®).
Secondary
- Evaluate the safety of this regimen in these patients.
- Determine overall clinical response rate in patients treated with this regimen.
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 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed infiltrating carcinoma of the breast or inflammatory breast cancer
- •Stage II-IIIB disease (T1-4, N1-2, M0)
- •Previously untreated disease
- •Previously unresected disease
- •High-risk disease that is not resectable by lumpectomy alone
- •Any HER2/neu status (positive, negative, or unknown) allowed
- •Hormone receptor status:
- •Any estrogen/progesterone status (positive, negative, or unknown) allowed
- •PATIENT CHARACTERISTICS:
- •Menopausal status not specified
- •ECOG performance status 0-2
- •Life expectancy > 3 months
- •Absolute neutrophil count > 1,500/mm³
- •Platelet count > 100,000/mm³
- •Hemoglobin > 9.0 g/dL
- •Creatinine < 1.5 mg/dL
- •Bilirubin < 1.5 times upper limit of normal (ULN)
- •ALT and AST < 2.5 times ULN (5 times ULN if due to Gilbert's disease)
- •Alkaline phosphatase < 2.5 times ULN (5 times ULN if due to Gilbert's disease)
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Pathological complete response rate
次要结局
- Overall clinical response rate
- Safety
研究者
研究点 (1)
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