G-CSF (Filgrastim) or Pegfilgrastim Secondary Prophylaxis In The Adjuvant Chemotherapy Of Early Breast Cancer
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 816
- 试验地点
- 64
- 主要终点
- Proportion of patients achieving ≥ 85% of planned dose intensity
研究概览
简要总结
RATIONALE: Colony-stimulating factors, such as filgrastim or pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether filgrastim or pegfilgrastim is more effective than standard treatment in preventing neutropenia in women who are receiving adjuvant chemotherapy for breast cancer.
PURPOSE: Randomized phase IV trial to compare the effectiveness of filgrastim or pegfilgrastim with that of standard treatment in preventing neutropenia in women who are receiving chemotherapy after undergoing surgery for breast cancer.
详细描述
OBJECTIVES:
- Determine the efficacy of filgrastim (G-CSF) or pegfilgrastim as secondary prophylaxis versus standard management after the first neutropenic event in maintaining dose-intensity of adjuvant chemotherapy in patients with early breast cancer.
- Determine the proportion of patients who experience at least one neutropenic event.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and under vs over 60) and participating center.
Patients receive chemotherapy as per local practice. After the first neutropenic event, patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive filgrastim (G-CSF) subcutaneously (SC) for 7 days beginning 2 days after the final dose in a course of adjuvant chemotherapy (e.g., beginning on day 3 for a course of chemotherapy administered on day 1 only OR beginning on day 10 for a course of chemotherapy administered on days 1 and 8) OR a single dose of pegfilgrastim SC administered approximately 24 hours after chemotherapy that is administered on day 1 only.
- Arm II: Patients receive standard conservative management. Patients are followed for up to 10 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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:
- •Histologically confirmed invasive breast cancer
- •No locally advanced or metastatic breast cancer, including supraclavicular fossa metastases
- •Prior neutropenic event on current chemotherapy regimen, defined as 1 of the following:
- •Hospitalization due to neutropenia
- •Absolute neutrophil count ≤ 1.5 times upper limit of normal and considered sufficiently low to require a treatment delay or a dose reduction > 15% of planned dose
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status:
- •Not specified
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •See Disease Characteristics
- •Not specified
- •Not specified
- •No other concurrent malignancy
- •Considered suitable risk and fitness status to continue adjuvant chemotherapy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior filgrastim (G-CSF) or pegfilgrastim
- •Chemotherapy:
- •See Disease Characteristics
- •No prior chemotherapy other than current regimen
- •Endocrine therapy:
- •Prior tamoxifen allowed
- •Radiotherapy:
- •Concurrent radiotherapy allowed
- •No concurrent sandwich/synchronous radiotherapy (i.e., administered during a break in the chemotherapy regimen)
- •See Disease Characteristics
- •Concurrent enrollment on other licensed chemotherapy trials allowed provided G-CSF is not excluded (e.g., TACT or TANGO trials)
- •Concurrent enrollment in the sequential arm of the SECRAB trial allowed (synchronous arm ineligible)
排除标准
- 未提供
结局指标
主要结局
Proportion of patients achieving ≥ 85% of planned dose intensity
Proportion of patients with ≥ 1 neutropenic event
次要结局
- Cost of management
- Dose intensity achieved