Randomized Phase II trial with cetuximab and cisplatin in the treatment of ER negative, PgR negative, HER2 negative metastatic breast carcinoma (basal-like”) - BALI-1

Merck KGaA0 个研究点目标入组 180 人开始时间: 2007年3月2日最近更新: 2014年10月7日

试验速览

暂无简介。

•- 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

•- 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.

发起方