Phase II of Combined Treatment of Cetuximab and Paclitaxel in Basal Like Breast Carcinoma
试验速览
- 阶段
- 1 期
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- tumor markers tumor size by ct
研究概览
简要总结
Basal like breast carcinoma is a Her2, estrogen receptor (ER) progesterone receptor (PR) negative breast cancer. It is notable for the high level of epidermal growth factor receptor (EGFR) expression in this tumor subtype .
Thus the investigators wanted to combine the use of anti EGFR therapy in the form of Erbitux (cetuximab) with the widely used weekly taxol chemotherapy for the treatment of these women. This is a small phase I/II study.
详细描述
Basal like breast carcinoma is a Her2, ER PR negative breast cancer. It is notable for the high percentage of EGFR expression in this tumor subtype.Weekly taxol (paclitaxel) is widely used in breast cancer patients with metastatic disease. Erbitux (cetuximab) is a monoclonal antibody that shown its ability to enhance activity of chemotherapy in colon carcinoma. Thus we wanted to combine the use of anti EGFR therapy in the form of Erbitux (cetuximab) with the widely used weekly taxol chemotherapy for the treatment of women with basal like breast carcinoma. This is a small phase II study that will hopefully provide initial data as to the general tolerability and response rate of this combination in this disease. Furthermore, pathologic analysis will be used to try and assess relation of response with the presence of immunohistochemical markers such as EGFR expression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients with metastatic breast carcinoma of the basal like subtype with available biopsy for analysis and ECOG PS of 2 or less
排除标准
- •Pregnancy
- •BUN, blood creatinine, AST, ALT > X3 of upper limits of normal
- •More than previous 2 chemotherapy lines in the metastatic settings or the use of previous inhibitors of EGFR
研究组 & 干预措施
1
干预措施: cetuximab paclitaxel (Drug)
结局指标
主要结局
tumor markers tumor size by ct
时间窗: two years
次要结局
未报告次要终点
