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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005000-13-IE

Enrollment

180

Registered

2007-02-12

Start date

2007-03-30

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic breast cancer PR-negative, ER-negative and HER-2 negative MedDRA version: 9.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer

Interventions

Trade Name: Erbitux 5 mg/ml Pharmaceutical Form: Solution for infusion INN or Proposed INN: Cetuximab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number:

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.;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.;Primary end point(s): Best overall response according to RECIST definitions	—

Measure

Time frame

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.;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.;Primary end point(s): Best overall response according to RECIST definitions

—

Countries

Austria, Germany, Ireland, Italy, Portugal, Spain, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026