NCT00544505Unknown不适用
Pre-operative Chemotherapy in Operable Breast Cancer, Phase III Study Comparing a Short Intensive Pre-operative Chemotherapy With the Same Therapy Initiated Shortly After Surgery(Peri-operatively)(POCOB)EORTC 10902)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 主要终点
- Efficacy
研究概览
简要总结
Pre-operative chemotherapy in operable breast cancer, phase III study comparing a short intensive pre-operative chemotherapy with the same therapy initiated shortly after surgery (peri-operatively) (POCOB) (EORTC 10902)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Disease Characteristics:
- •Palpable, operable breast cancer that has been diagnosed by core needle biopsy (mandatory for T1c tumors) or fine needle aspiration within 21 days prior to entry
- •Stage T1c-4b, N0-1, M0
- •Hormone receptor status:
- •Not specified
- •No bilateral breast cancer
- •Prior/Concurrent Therapy:
- •No previous treatment for breast cancer
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No previous chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Core needle biopsy or fine needle aspiration within 21 days prior to entry
- •Repeated core needle biopsy permitted
- •Patient Characteristics:
- •Women only
- •Menopausal status:
- •Not specified
- •Performance status:
- •Hematopoietic:
- •WBC at least 4,000
- •Platelets at least 100,000
- •Bilirubin no greater than 2.8 mg/dL (50 micromoles/L)
- •Creatinine no greater than 1.3 mg/dL (120 micromoles/L)
- •Cardiovascular:
- •No congestive heart failure
- •No significant arrhythmia
- •No bilateral bundle branch block
- •No recent myocardial infarction
- •No uncontrolled hypertension (diastolic pressure greater than 110 mm Hg)
- •No male breast cancer
- •No pregnant or nursing women
- •No second malignancy except adequately treated:
- •Nonmelanomatous skin cancer
- •Cervical cancer
排除标准
- 未提供
结局指标
主要结局
Efficacy
时间窗: overall
次要结局
未报告次要终点
研究者
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