A Randomized Multicenter Trial Comparing Weekly Docetaxel and CMF in the Adjuvant Treatment of Women With High-Risk Breast Cancer Who Are > 65 Years Old or Are Not Candidates for Anthracycline-Based Adjuvant Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- disease-free survival
研究概览
简要总结
This trial will evaluate the effectiveness of standard adjuvant treatment with CMF chemotherapy versus treatment with weekly docetaxel in patients with high-risk breast cancer who are 65 years of age and older or are poor candidates for anthracycline-containing regimens. This CMF regimen has decreased dose intensity and may be slightly less active in patients with metastatic breast cancer; however, the patient population in this trial has tolerated more intensive CMF regimens poorly in other trials.
详细描述
Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:
- Docetaxel
- Cyclophosphamide + Methotrexate + 5-fluorouracil
This is not a blinded study so both the patient and the investigator will know which treatment has been assigned.
Chemotherapy will be followed by breast and/or regional radiotherapy in appropriate patients, and by hormone therapy with tamoxifen for 5 years in patients who are estrogen-receptor positive. Patients who are considered poor candidates to receive tamoxifen may receive hormonal therapy with anastrazole.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •To be included in this study, you must meet the following criteria:
- •Female patients with adenocarcinoma of the breast confirmed by biopsy
- •Age 65 or older
- •Under age 65 must have significant medical illness, or general frailty
- •Adequate bone marrow, liver or kidney function
- •Normal heart function
- •Less than 84 days from mastectomy/lumpectomy or axillary dissection
- •Signed consent obtained prior to initiation of any study procedures
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Received neo-adjuvant therapy
- •Primary tumor is locally advanced at diagnosis
- •Received prior chemotherapy within five years
- •Received previous radiation therapy within 5 years
- •Peripheral neuropathy
- •Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
研究组 & 干预措施
1
Docetaxel
干预措施: Docetaxel (Drug)
2
Cyclophosphamide + Methotrexate + 5-fluorouracil
干预措施: Cyclophosphamide (Drug)
2
Cyclophosphamide + Methotrexate + 5-fluorouracil
干预措施: Methotrexate (Drug)
2
Cyclophosphamide + Methotrexate + 5-fluorouracil
干预措施: 5-Fluorouracil (Drug)
结局指标
主要结局
disease-free survival
时间窗: 18 months
次要结局
- overall survival(18 months)
- toxicity(18 months)