Randomized Phase II Trial With Cetuximab and Cisplatin in the Treatment of ER-negative, PgR-negative, HER2-negative Metastatic Breast Carcinoma ("Basal Like")
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 1
- 主要终点
- Best Overall Response (BOR)
研究概览
简要总结
The primary objective of this study is to determine whether overall response to cetuximab combined with cisplatin is better than overall response to cisplatin alone together with showing that the overall response for cetuximab and cisplatin was above a pre-specified threshold of 0.2 in the treatment of "triple negative" metastatic breast cancer.
The secondary objective of this study is to compare the differences between the two treatment groups using the following criteria : Progression-Free Survival (PFS) Time, Overall Survival (OS), Time to Response (TTR) and Safety.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of metastatic breast cancer (Stage IV)
- •Estrogen Receptor [ER] negative, PgR negative and HER2 less than 3+ expression by immunohistochemistry (IHC)
- •No more than 1 prior chemotherapy received for treating this metastatic breast cancer
- •No more than 1 prior anthracycline and/or taxane regimen (either adjuvant or metastatic setting)
- •Other protocol-defined inclusion criteria may apply
排除标准
- •Prior platinum agent
- •Prior mitomycin
- •Known history of brain metastases
- •Other protocol-defined exclusion criteria may apply
研究组 & 干预措施
cisplatin and cetuximab
干预措施: cetuximab, cisplatin (Drug)
cisplatin
干预措施: cisplatin (Drug)
结局指标
主要结局
Best Overall Response (BOR)
时间窗: Evaluations were performed every 6 weeks until progression reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009
Percentage of participants with best overall (objective) response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).
次要结局
- Time to Response (TTR)(Time from the first dose of study treatment (cetuximab or cisplatin) to first assessment of CR or PR, reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009)
- Safety- Number of Participants Experiencing Any Adverse Event (AE)(Time from first dose up to 30 days after last dose of study treatment, reported between day of first dose of study treatment, 20 June 2007, until cut-off date 05 April 2010)
- Progression-Free Survival (PFS) Time(Time from randomization to disease progression, death or last tumour assessment, reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009)
- Overall Survival (OS) Time(Time from randomization to death or last day known to be alive, reported between day of first participant randomized, 20 June 2007, until cut-off date, 05 April 2010)