NCT00771433已完成2 期
Evaluation of the Efficacy of Adding Daily G-CSF (Granulocyte Colony Stimulating Factor) for Prevention of Hematologic Toxicity Due to Neoadjuvant or Adjvuant Chemotherapy in Breast Cancer
Centre Francois Baclesse2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2007年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Occurrence of febrile neutropenia
研究概览
简要总结
RATIONALE: G-CSF may prevent or reduce febrile neutropenia in women receiving chemotherapy for breast cancer. It is not yet known which G-CSF regimen is more effective in preventing neutropenia.
PURPOSE: This phase II trial is studying how well G-CSF works in preventing neutropenia in women receiving chemotherapy for breast cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the efficacy of filgrastim (G-CSF) in preventing hematological toxicity in women with breast cancer receiving neoadjuvant or adjuvant chemotherapy.
Secondary
- Compare actual vs theoretical dose intensity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Supportive Care
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:
- •Diagnosis of breast cancer
- •Receiving 1 of the following neoadjuvant or adjuvant chemotherapy regimens:
- •Six courses of epirubicin hydrochloride and docetaxel
- •Six courses of fluorouracil, epirubicin hydrochloride, and cyclophosphamide (FEC) 100 or 3 courses of FEC 100 and 3 courses of docetaxel 100
- •Must have received at least 2 chemotherapy regimens prior to study therapy
- •No malignant hematological disease
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status not specified
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No contraindications to standard neoadjuvant or adjuvant chemotherapy
- •No known hypersensitivity to G-CSF or any of its components
- •No patients deprived of liberty or under guardianship
- •No psychological, familial, social, or geographical reasons preventing follow-up
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No concurrent participation in another experimental drug study
排除标准
- 未提供
结局指标
主要结局
Occurrence of febrile neutropenia
次要结局
未报告次要终点
研究者
研究点 (2)
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