NCT01031030Unknown3 期
Adjuvant Treatment of Biologically Aggressive Breast Cancer (N-,N+1,3): Controlled Clinical Study
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS0 个研究点目标入组 800 人开始时间: 1997年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 800
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, methotrexate, fluorouracil, and epirubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving cyclophosphamide together with methotrexate and fluorouracil before, after, or without epirubicin hydrochloride is more effective in treating patients with breast cancer that can be removed by surgery.
PURPOSE: This randomized phase III trial is comparing three regimens of cyclophosphamide given together with methotrexate and fluorouracil, with or without epirubicin hydrochloride, to see how well it works in treating women who have undergone surgery for breast cancer. (Group III was closed to new patients as of 12/7/2009.)
详细描述
OBJECTIVES:
Primary
- To determine the impact of adjuvant chemotherapy comprising epirubicin hydrochloride followed by cyclophosphamide, methotrexate, and fluorouracil versus cyclophosphamide, methotrexate, and fluorouracil followed by epirubicin hydrochloride versus cyclophosphamide, methotrexate, and fluorouracil on overall survival of patients with biologically aggressive, resectable, node-negative or node-positive breast cancer.
Secondary
- To assess the disease-free survival and patterns of relapse in these patients.
- To assess the tolerance to and toxicity of treatment in these patients.
- To determine the quality of life of these patients.
- To verify the effectiveness of these treatments in different subgroups of patients.
- To collect, retrospectively, information on the expression of tumor suppressor gene p53, oncogene c-erbB-2, and bcl-2 protein involved in apoptosis. (exploratory)
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 70 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
- •Underwent radical mastectomy, guadrantectomy, or tumorectomy with axillary node dissection within the past 4-6 weeks
- •Biologically aggressive disease
- •At least 10 lymph nodes removed
- •Node-negative (> 1 cm, or > 2 cm if histology is favorable, esp. tubular carcinoma and/or prevalent intraductal component > 50%) tumors OR node-positive (1-3) tumors, meeting the following criteria:
- •High thymidine-labeling index (> 3%)
- •Poorly differentiated tumor (grade III)
- •High S-phase fraction (> 10% by flow cytometry)
- •High Ki67/MIB1 expression (< 20%)
- •No bilateral breast cancer
- •No T4a, inoperable T4b, T4c, or T4d disease
- •Any estrogen receptor status (positive, negative, unknown)
- •No distant metastases
- •PATIENT CHARACTERISTICS:
- •Any menopause status
- •WBC ≥ 3,500/mL
- •ANC ≥ 1,500/mL
- •Platelet count ≥ 120,000/mL
- •AST and ALT ≤ 1.5 times upper limit of normal (ULN)
- •Creatinine ≤ 1.5 mg/mL
- •Bilirubin ≤ 1.5 times ULN
- •Not pregnant
- •Geographically accessible for follow-up
- •No prior breast cancer and/or other cancer except for carcinoma in situ of the cervix or basal cell skin cancer treated with radical intent
- •No significant alterations in cardiovascular function
- •No serious psychiatric disorders
- •No impaired renal or liver function
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Overall survival
次要结局
- Efficacy in subgroups of patients
- Toxicity
- Disease-free survival
- Quality of life
研究者
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