Phase I Study Investigating the Combined Immunotherapy With Trastuzumab and Cetuximab in Patients With Metastatic Breast Cancer With High and Moderate HER2 Expression
试验速览
- 阶段
- 1 期
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Pharmacokinetics and drug/drug interaction of cetuximab and
研究概览
简要总结
One important approach to change the natural history of advanced breast cancer is that of designing new combination chemotherapies in which the best drugs already available are used together with new anticancer agents devoid of clinical cross-resistance. The possibility of exploiting the combined use of cetuximab and trastuzumab represents an option of potential great impact on the probability of response and long-term therapeutic results for patients with advanced breast cancer and HER2 overexpression.Therefore, patients with tumors that demonstrate EGFR expression and clear-cut erbB-2 overexpression (3+) or limited erbB-2 overexpression (+ or 2+) will be included in the study. Patients will be treated with trastuzumab and cetuximab to study the pharmacokinetics and potential drug/drug interaction of both antibodies as well as the safety and tolerability of this novel combination treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •diagnosis of metastatic breast cancer
- •presence of at least 1 measurable lesion according to modified RECIST criteria
- •Evidence (fluorescence in situ hybridization FISH) of
- •Her-2 overexpression in tumor tissue:Group A: Her-2 +++, Group B: Her-2 + or ++
- •EGFR-expressing disease as assessed by immunohistochemistry
- •Recovered from relevant toxicities from other treatment prior to study entry
排除标准
- •Prior treatment with trastuzumab for metastatic breast cancer (adjuvant therapy is allowed)
- •Prior treatment with cetuximab
- •Concomitant cytotoxic chemotherapy
- •Treatment with any investigational agent(s) within 4 weeks prior to study entry
- •Known allergic/hypersensitivity reaction to any of the components of study treatments
- •severe dyspnea
- •Myocardial infarction within 6 months prior to study entry, uncontrolled congestive heart failure; or any current grade 3 or 4 cardio-vascular disorder despite treatment
- •History of significant neurologic or psychiatric disorders
结局指标
主要结局
Pharmacokinetics and drug/drug interaction of cetuximab and
时间窗: repeated PK measurements week 1-13
次要结局
- Safety and tolerability of the combination treatment(week 1 -13)
- Response(week 9 and 13)