A Phase III Randomized Study of EC Followed by Paclitaxel Versus FEC Followed by Paclitaxel, All Given Either Every 3 Weeks or 2 Weeks Supported by Pegfilgrastim, for Node Positive Breast Cancer Patients
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
- 主要终点
- Disease-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, paclitaxel, and fluorouracil, 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 pegfilgrastim, 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 and pegfilgrastim after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy is more effective with or without fluorouracil and/or pegfilgrastim in treating breast cancer.
PURPOSE: This randomized phase III trial is studying combination chemotherapy to compare how well it works when given with or without fluorouracil and/or pegfilgrastim in treating women with node-positive breast cancer.
详细描述
OBJECTIVES:
Primary
- Compare the efficacy of adjuvant therapy comprising epirubicin hydrochloride, cyclophosphamide, and paclitaxel with vs without fluorouracil and/or pegfilgrastim in women with node-positive breast cancer.
Secondary
- Compare the overall survival of patients treated with these regimens.
- Compare the safety of these regimens in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed primary breast cancer
- •No histology other than carcinoma
- •Node-positive disease
- •Must have at least 1 involved axillary node or internal mammary node
- •Previously resected disease
- •Has undergone radical surgery (i.e., mastectomy or conservative surgery) with axillary node dissection within the past 7 weeks
- •No inflammatory carcinoma
- •No prior or concurrent ipsilateral or contralateral invasive breast carcinoma
- •No metastatic disease, including metastasis in the ipsilateral supraclavicular lymph nodes
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status not specified
- •ECOG performance status 0-1
- •Absolute neutrophil count ≥ 1,500/mm³
- •WBC ≥ 4,000/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 9 g/dL
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •Creatinine ≤ 1.5 times ULN
- •AST and ALT ≤ 2.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No chronic liver or renal disease
- •No other serious medical illness requiring medication
- •No other malignancy except adequately treated, cone-biopsied in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin
- •No symptomatic peripheral neuropathy > grade 2
- •No hypersensitivity to study drugs or their components
- •No recent myocardial infarction, congestive heart failure, or serious arrhythmia
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior chemotherapy
- •No prior cytotoxic regimens
- •No prior radiation therapy, except for intraoperative radiation therapy
排除标准
- 未提供
结局指标
主要结局
Disease-free survival
次要结局
- Overall survival
- Toxicity
研究者
Lucia Del Mastro,MD
MD
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy