Spots Global Cancer Trial Database for Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer
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Trial Identification
Brief Title: Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer
Official Title: A Phase II Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of Lapatinib in Combination With Paclitaxel as Neoadjuvant Therapy in Patients With Newly Diagnosed Inflammatory Breast Cancer
Study ID: NCT00111787
Conditions
Study Description
Brief Summary: This Study was designed to determine how effective and safe a new investigational drug, lapatinib, is in combination with paclitaxel in treating patients with newly diagnosed inflammatory breast cancer. Tumor tissue collected pre-treatment, following 14 days of treatment and at the time of surgical resection will be examined for pathologic response and biologic activity by IHC (immunohistochemistry) within the tumor. Treatment will consist of 14 days of lapatinib monotherapy followed by 12 weeks of combination therapy with lapatinib and paclitaxel. Blood samples for hematology and chemistry panels, MUGA/ECHO exams and physical exams will be performed throughout the study to monitor safety.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
GSK Investigational Site, Miami, Florida, United States
GSK Investigational Site, Chicago, Illinois, United States
GSK Investigational Site, Zion, Illinois, United States
GSK Investigational Site, Houston, Texas, United States
GSK Investigational Site, Campbelltown, New South Wales, Australia
GSK Investigational Site, Liverpool, New South Wales, Australia
GSK Investigational Site, Randwick, New South Wales, Australia
GSK Investigational Site, South Brisbane, Queensland, Australia
GSK Investigational Site, Bedford Park, South Australia, Australia
GSK Investigational Site, Box Hill, Victoria, Australia
GSK Investigational Site, Ringwood East, Victoria, Australia
GSK Investigational Site, Toronto, Ontario, Canada
GSK Investigational Site, Bayonne, , France
GSK Investigational Site, Lille Cedex, , France
GSK Investigational Site, Paris cedex 13, , France
GSK Investigational Site, Ramat Gan, , Israel
GSK Investigational Site, Auckland, , New Zealand
GSK Investigational Site, Barcelona, , Spain
GSK Investigational Site, Girona, , Spain
GSK Investigational Site, Valencia, , Spain
GSK Investigational Site, Sfax, , Tunisia
GSK Investigational Site, Sfax, , Tunisia
GSK Investigational Site, Tunis, , Tunisia
GSK Investigational Site, Tunis, , Tunisia
GSK Investigational Site, London, , United Kingdom
Contact Details
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR
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