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

• Conditions: Metastatic breast cancer PR-negative, ER-negative and HER-2 negative; MedDRA version: 9.1Level: LLTClassification code 10027475Term: Metastatic breast cancer

• Registration Number: EUCTR2006-005000-13-DE
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

- 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
- At least one prior anthracycline and taxane regimen received either as 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

Exclusion Criteria

- 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