Adjuvant Therapy of Breast Cancer: Impact of Erythropoiesis Stimulating Factors on Event Free Survival High Risk Breast Cancer Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,234
- 试验地点
- 94
- 主要终点
- Disease-free survival at 6 months to 5 years after treatment
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy 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. Colony-stimulating factors, such as darbepoetin alfa, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with darbepoetin alfa after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy and darbepoetin alfa are more effective than combination chemotherapy alone in treating stage III breast cancer.
PURPOSE: This randomized clinical trial is studying how well giving combination chemotherapy together with darbepoetin alfa works compared to combination chemotherapy alone in treating women with stage III breast cancer.
详细描述
OBJECTIVES:
Primary
- Compare the disease-free survival rate in women with stage III breast cancer treated with adjuvant chemotherapy with vs without darbepoetin alfa.
Secondary
- Compare local recurrence and overall survival in patients receiving these regimens.
- Compare toxicity of these regimens in these patients.
- Compare quality of life and fatigue frequency in patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed breast cancer
- •Stage III disease (pT1, N2-3, M0)
- •No metastatic disease by thoracic x-ray, full-body bone scan, and liver sonography
- •No inflammatory disease or Paget's disease
- •Disease completely resected (R0) and ≥ 10 axillary lymph nodes removed
- •Underwent surgery approximately 42 days ago
- •At least 9 positive lymph nodes
- •No prior sequential mastectomy
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status not specified
- •ECOG performance status 0-1
- •WBC ≥ 3,500/mm^3
- •Creatinine ≤ 1.4 mg/dL
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 2.0 mg/dL
- •No pre-existing symptomatic peripheral neuropathy
- •Not pregnant or nursing
- •No hypersensitivity to darbepoetin alfa, epoetin alfa, or any of their components
- •No other malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No participation in another clinical study
- •No prior therapies that would preclude study participation
排除标准
- 未提供
结局指标
主要结局
Disease-free survival at 6 months to 5 years after treatment
次要结局
- Overall survival at 6 months to 5 years after treatment
- Toxicity by NCI toxicity criteria at every course and periodically thereafter
- Anemia and cognitive function by Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) at every course
- Local relapses at 6 months to 5 years after treatment