None listed
Conditions
Interventions
Paclitaxel + GW572016 (Lapatinib) Type of group
Lapatinib 1500 mg once daily and Paclitaxel 175 mg / m intravenously for 3 hours every 3 weeks
Group name:Paclitaxel Type of group
Paclitaxel 175 mg / m intravenously for 3 hours every 3 weeks and placebo
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: Signed Informed Consent Able to swallow an oral medication Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram Adequate kidney and liver function Adequate bone marrow function Tumor tissue available for testing Prior adjuvant or neoadjuvant therapy is permitted with an anthracycline or anthracenedione-containing regimen however, subjects must have had cumulative doses of less than 360 mg/m2 of doxorubicin, 720 mg/m2 of epirubicin, or 72 mg/m2 of mitoxantrone No Her2/neu overexpression in tumor tissue tested or status unknown if tissue has never been tested
Exclusion criteria
Exclusion criteria: Prior treatment regimens for advanced or metastatic breast cancer. Pregnant or lactating Conditions that would effect the absorption of an oral drug Active infection Brain metastases Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor. Known hypersensitivity to Taxol or excipients of Taxol Peripheral neuropathy of Grade 2 or greater is not permitted Severe Cardiovascular disease or cardiac disease requiring a device. Serious medical or psychiatric disorder that would interfere with the patient´s safety or informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Randomization until the date of disease progression or death Measure:Time to Progression as Evaluated by the Investigator Timepoints:average of 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Randomization until the date of disease progression or death Measure:Number of Participants With Tumor Response as Evaluated by the Investigator Timepoints:average of 26 weeks | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Germany, Hungary, Italy, Korea North, Latvia, Mexico, Netherlands, New Zealand, Pakistan, Peru, Poland, Russian Federation, Slovakia, South Africa, Spain, Turkey, United States
Outcome results
None listed