Randomized Phase III Trial of Herceptin® Followed by Chemotherapy Plus Herceptin® Versus the Combination of Herceptin® and Chemotherapy as Palliative Treatment in Patients With HER2- Overexpressing Advanced/Metastatic Breast Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 175
- 试验地点
- 17
- 主要终点
- Time to progression on combined HerChemo (TTPHerChemo)
研究概览
简要总结
RATIONALE: To compare efficacy, toxicity and quality of life of the sequential administration of Her alone followed, at PD, by the combination with Chemotherapy (Arm A) vs. the upfront combination of Her and Chemotherapy (Arm B) in patients with advanced/metastatic breast cancer.
PURPOSE: Trial SAKK 22/99 addresses clinically relevant and currently unresolved questions regarding the optimal use of Herceptin in the treatment of patients with advanced/metastatic breast cancer.
详细描述
In advanced HER2+ breast cancer the impact of combining Trastuzumab (T) and chemotherapy (chemo) versus T alone followed by the addition of chemo at disease progression has not been properly studied.
The trial compared efficacy, toxicity and quality of life of sequential administration of T followed, at progression, by combination with chemo (T>TChemo) versus the upfront combination of T and chemo (TChemo) in patients with HER2+ advanced breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Herceptin™ (Her)
Herceptin™ (Her) loading dose 4 mg/kg iv, followed by 2 mg/kg iv weekly or loading dose 8 mg/kg iv, followed by 6 mg/kg iv every 3 weeks; at time of progression add chemotherapy
干预措施: Herceptin™ (Her) (Drug)
Herceptin™+Chemo
Herceptin™ (Her) loading dose 4 mg/kg iv, followed by 2 mg/kg iv weekly or loading dose 8 mg/kg iv, followed by 6 mg/kg iv every 3 weeks, and chemotherapy
干预措施: Herceptin™ (Her) + chemo (Drug)
结局指标
主要结局
Time to progression on combined HerChemo (TTPHerChemo)
时间窗: 8 weeks
次要结局
- Time to first progression(8 weeks)
- Time to treatment failure(8 weeks)
- Overall survival(8 weeks)
- Adverse events(8 weeks)
- Conversion rate of estrogen receptor status(8 weeks)
- Association of immunoprofiles of erbB-1, erbB-2, erbB-3 and erbB-4 with clinical outcome(8 weeks)
- Response rate(8 weeks)
- Predictive value of serum HER2/neu ECD levels on clinical outcome(8 weeks)