Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer
- Conditions
- C50-C50 Malignant neoplasm of breastMalignant neoplasm of breast
- Registration Number
- PER-045-04
- Lead Sponsor
- GLAXOSMITHKLINE PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 40
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Randomization until the date of disease progression or death<br>Measure:Time to Progression as Evaluated by the Investigator<br>Timepoints:average of 26 weeks<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Randomization until the date of disease progression or death<br>Measure:Number of Participants With Tumor Response as Evaluated by the Investigator<br>Timepoints:average of 26 weeks<br>