Breast Cancer Clinical Trial
Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer
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.
Eligibility Criteria
Inclusion criteria:
Tumor accessible for multiple biopsies
ECOG (Eastern Cooperative Oncology Group) performance status 0-2
Adequate bone marrow
Renal and hepatic function
LVEF (left ventricular ejection fraction) greater than 0% based on ECHO (echocardiogram) or MUGA (multigated acquisition).
Exclusion criteria:
Females who are pregnant or nursing.
Any unstable, pre-existing major medical condition.
Received an investigational drug within the past 4 weeks.
Had major surgery in the past 2 weeks.
Currently receiving amiodarone or has received amiodarone in the past 6 months.
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There are 23 Locations for this study
Miami Florida, 33136, United States
Chicago Illinois, 60637, United States
Zion Illinois, 60099, United States
Houston Texas, 77030, United States
Campbelltown New South Wales, 2560, Australia
Liverpool New South Wales, 2170, Australia
Randwick New South Wales, 2031, Australia
South Brisbane Queensland, 4101, Australia
Bedford Park South Australia, 5042, Australia
Box Hill Victoria, 3128, Australia
Ringwood East Victoria, 3128, Australia
Toronto Ontario, M4N 3, Canada
Bayonne , 64100, France
Lille Cedex , 59020, France
Paris cedex 13 , 75651, France
Ramat Gan , 52621, Israel
Auckland , , New Zealand
Barcelona , 08035, Spain
Girona , 17007, Spain
Valencia , 46010, Spain
Sfax , 3000, Tunisia
Sfax , 3029, Tunisia
Tunis , 1004, Tunisia
Tunis , 1007, Tunisia
London , SW3 6, United Kingdom
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