Randomized Phase II trial with cetuximab and cisplatin in the treatment of ER-negative, PgRnegative, HER2-negative metastatic breast carcinoma (?basal-like?) - ND
- Conditions
- Metastatic Breast Cancer (Stage IV) basal like.MedDRA version: 9.1Level: LLTClassification code 10006279Term: Breast neoplasm
- Registration Number
- EUCTR2006-005000-13-IT
- Lead Sponsor
- Merck KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 180
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess overall response to cetuximab in combination with cisplatin and to show the superiority of the combination over cisplatin alone, in subjects with ?triple negative? metastatic breast cancer.;Secondary Objective: To compare the differences between the 2 treatment groups using: progression-free survival (PFS), overall survival (OS), time to response and safety. To investigate downstream effects on biomarkers and population pharmacokinetics.;Primary end point(s): Best overall response according to RECIST definitions
- Secondary Outcome Measures
Name Time Method