EUCTR2006-005000-13-IT进行中（未招募）不适用
Randomized Phase II trial with cetuximab and cisplatin in the treatment of ER-negative, PgRnegative, HER2-negative metastatic breast carcinoma (?basal-like?) - ND
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Female inpatient/outpatient >=18 years of age ? Histologically confirmed diagnosis of metastatic breast cancer (Stage IV). Estrogen receptor (ER)-negative, progesterone receptor (PgR)-negative and HER2 <3+ expression by immunohistochemistry (IHC) (fluorescence in situ hybridization [FISH] test negative if 1+ or 2+ by IHC) (this confirmatory test should be performed when possible) ? No more than one prior chemotherapy regimen received for treating this metastatic breast cancer ? No more than one prior anthracycline and/or taxane regimen (either adjuvant or metastatic setting) ? At least one measurable lesion by CT or MRI according to RECIST ? Signed written informed consents prior to starting any study investigation ? Tumor tissue available for EGFR expression assessment and exploratory biomarker analysis ? Eastern Cooperative Oncology Group (ECOG) PS 0-2 and life expectancy of at least 6 months at study entry.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Prior platinum agent ? Prior mitomycin ? Known history of brain metastases ? Previous or current malignancy except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix ? Previous exposure to monoclonal antibody therapy, signal transduction inhibitors or EGFR-targeting therapy ? Any investigational medication within 30 days before study entry.
研究者
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