Status:
COMPLETED
Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neoplasms, Breast
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in first line advance...
Eligibility Criteria
Inclusion
- 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:
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
580 Patients enrolled
Trial Details
Trial ID
NCT00075270
Start Date
January 1 2004
End Date
March 1 2012
Last Update
May 6 2015
Active Locations (177)
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1
GSK Investigational Site
Tucson, Arizona, United States, 85712
2
GSK Investigational Site
Hot Springs, Arkansas, United States, 71913
3
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
4
GSK Investigational Site
Fountain Valley, California, United States, 92708