Adjuvant Chemotherapy in Elderly Patients With Breast Cancer: Weekly Docetaxel vs. CMF
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- disease free survival
研究概览
简要总结
The purpose of this study is to compare disease free survival of elderly breast cancer patients treated with standard adjuvant chemotherapy (CMF) versus experimental adjuvant chemotherapy (weekly docetaxel).
详细描述
Adjuvant combination chemotherapy, given after breast cancer surgery, has been established as the standard approach to reduce the risk of breast cancer recurrence in those patients at intermediate or high risk for recurrence. However, since elderly patients have been underrepresented in past clinical trials, the optimal adjuvant therapy for elderly patients at risk for recurrence has not yet been defined.
Docetaxel is one of the most active drugs for patients with metastatic breast cancer and several trials are evaluating its efficacy in the adjuvant setting. Administration of docetaxel on a weekly schedule is effective and well tolerated in women with metastatic breast cancer.
In this study, patients from ages 65 to 80 will be randomized to one of two treatment strategies:
- standard adjuvant chemotherapy with CMF (cyclophosphamide, methotrexate, and 5-fluorouracil given intravenously on days 1 and 8 of each cycle)
- experimental adjuvant chemotherapy with weekly docetaxel (given intravenously on days 1,8, and 15 of each cycle)
In both treatment strategies:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed invasive unilateral breast cancer
- •Age > 65 and < 80 years
- •Intermediate-high risk of recurrence according to St. Gallen criteria: ER negative and PgR negative, or axillary lymph node metastasis, or tumor size > 2 cm, or tumor grade 2 or 3 (intermediate or high)
排除标准
- •Performance status >1
- •Distant metastasis
- •Concomitant malignancy or malignancy within previous 5 years (except basal cell or spinocellular skin cancer and in situ cervical cancer if they have been adequately treated
- •Previous breast cancer treatment
- •Neutrophils < 2000/mm3 or platelets < 100000/mm3 or haemoglobin < 10 g/dl
- •Creatinine > 1.25 the upper normal limit
- •GOT and-or GPT and/or bilirubin > 1.25 the upper normal limit
- •Concomitant conditions that contraindicate the use of the drugs in the protocol
- •Incapacity or refusal to provide informed consent
研究组 & 干预措施
A
Standard chemotherapy with CMF
干预措施: 5-fluorouracil (Drug)
A
Standard chemotherapy with CMF
干预措施: cyclophosphamide (Drug)
A
Standard chemotherapy with CMF
干预措施: methotrexate (Drug)
B
Weekly docetaxel
干预措施: docetaxel (Drug)
结局指标
主要结局
disease free survival
时间窗: at 5 years
次要结局
- toxicity(weekly)
- compliance(every 3 weeks)
- overall survival(at 5 years)
- quality of life(baseline and every 3 weeks during therapy)