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临床试验/NCT00353717
NCT00353717Unknown1 期

Phase II of Combined Treatment of Cetuximab and Paclitaxel in Basal Like Breast Carcinoma

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2006年11月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

研究者

申办方类型
Other

研究点 (1)

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