Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer

Completed · Phase 3

Conditions studied: Neoplasms, Breast

In brief

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 advanced or metastatic breast cancer.

Key facts

Study ID

NCT00075270

Run by

GlaxoSmithKline

People needed

580

Starts

2004-01-01

Expected to finish

2012-03-01

Last updated by the study team

2015-05-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Hot Springs, Arkansas, United States
• GSK Investigational Site — Jonesboro, Arkansas, United States
• GSK Investigational Site — Fountain Valley, California, United States
• GSK Investigational Site — La Jolla, California, United States
• GSK Investigational Site — Rancho Mirage, California, United States
• GSK Investigational Site — Vallejo, California, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Boca Raton, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Port Saint Lucie, Florida, United States
• GSK Investigational Site — West Palm Beach, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Marietta, Georgia, United States
• GSK Investigational Site — Savannah, Georgia, United States
• GSK Investigational Site — Savannah, Georgia, United States
• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — Kansas City, Kansas, United States
• GSK Investigational Site — Metairie, Louisiana, United States
• GSK Investigational Site — Baltimore, Maryland, United States
• GSK Investigational Site — Glen Burnie, Maryland, United States
• GSK Investigational Site — Springfield, Massachusetts, United States
• GSK Investigational Site — Duluth, Minnesota, United States
• GSK Investigational Site — Robbinsdale, Minnesota, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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