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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00281658 |
This is a Phase III study designed to evaluate the response(shrinkage or lack of growth)of tumors of lapatinib plus paclitaxel compared to paclitaxel plus placebo as first line metastatic treatment in women and men who have metastatic breast cancer. Patients will be evaluated for safety and efficacy. Countries include China, Hong Kong, Thailand, Brazil and Peru.
Condition | Intervention | Phase |
---|---|---|
Metastatic Breast Cancer |
Drug: lapatinib (GW572016) oral tablets Drug: paclitaxel infusion |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Study of Lapatinib (GW572016) in Combination With Paclitaxel Versus Paclitaxel Plus Placebo in Subjects With ErbB2 Amplified Metastatic Breast Cancer |
Estimated Enrollment: | 424 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Patients with visceral disease that requires chemotherapy (eg., patients with liver or lung metastases) Rapidly progressing or life threatening disease, as determined by the investigator Patients who received hormonal therapy and are no longer benefiting from this therapy and the hormonal treatment must have been stopped before the first dose of investigational treatment;
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | EGF104535 |
Study First Received: | January 23, 2006 |
Last Updated: | November 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00281658 |
Health Authority: | United States: Food and Drug Administration; China: State Food and Drug Administration |
metastatic breast cancer Stage IV breast cancer paclitaxel Taxol |
lapatinib anibGw572016 ErbB2 positive FISH positive |
Skin Diseases Paclitaxel Breast Neoplasms Lapatinib Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Mitosis Modulators |
Tubulin Modulators Enzyme Inhibitors Antimitotic Agents Protein Kinase Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |