Randomized Phase II trial with cetuximab and cisplatin in the treatment of ER negative, PgR negative, HER2 negative metastatic breast carcinoma (basal-like”)Estudio randomizado de fase II con cetuximab y cisplatino en el tratamiento del carcinoma de mama metastásico RE-negativo, RPg-negativo, y HER2-negativo (tipo basal) - BALI-1
- Conditions
- Metastatic breast cancer PR-negative, ER-negative and HER-2 negativeCarcinoma de mama metastásico PR-negativo, ER-negativo y HER-2 negativoMedDRA version: 9.1Level: LLTClassification code 10027475Term: Metastatic breast cancer
- Registration Number
- EUCTR2006-005000-13-ES
- Lead Sponsor
- Merck KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 0
- 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