A Randomized Phase II Study Of CMF Alone And In Combination With Anti c-erbB2 Antibody (Herceptin) In Women With c-erbB2 Positive Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 13
- 主要终点
- Clinical heart failure rate measured by New York Heart Association classification, LVEF, and ECG
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy such as cyclophosphamide, methotrexate, and fluorouracil use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with trastuzumab may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining combination chemotherapy with trastuzumab in treating women who have metastatic breast cancer.
详细描述
OBJECTIVES:
- Compare the incidence of clinical heart failure in women with c-erbB2-positive metastatic breast cancer treated with cyclophosphamide, methotrexate, and fluorouracil in combination with trastuzumab (Herceptin®).
- Compare the therapeutic activity of this regimen, in terms of objective response rate, in these patients.
- Compare the duration of response and time to progression in patients treated with this regimen.
- Compare the toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive CMF comprising cyclophosphamide orally on days 1-14 or IV on days 1 and 8 and methotrexate IV and fluorouracil IV on days 1 and 8. Patients also receive trastuzumab (Herceptin®) IV over 30-90 minutes once weekly beginning on day 1. Treatment repeats every 4 weeks for 8 courses. Patients then receive trastuzumab once every 3 weeks in the absence of disease progression, unacceptable toxicity, or patient refusal.
Patients are followed every 8 weeks until documentation of disease progression or initiation of a new anticancer therapy. Patients developing disease progression are followed every 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CMF + Herceptin
干预措施: trastuzumab (Biological)
CMF + Herceptin
干预措施: CMF regimen (Drug)
CMF + Herceptin
干预措施: cyclophosphamide (Drug)
CMF + Herceptin
干预措施: fluorouracil (Drug)
CMF + Herceptin
干预措施: methotrexate (Drug)
结局指标
主要结局
Clinical heart failure rate measured by New York Heart Association classification, LVEF, and ECG
时间窗: from registration
Response rate by RECIST
时间窗: from registration
次要结局
- Duration of response by RECIST(from registration)
- Time to progression(from registration)
- Toxicity measured by CTC v2.0(from registration)