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.

View Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

49

Study ID:

NCT00111787

Recruitment Status:

Completed

Sponsor:

GlaxoSmithKline

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There are 23 Locations for this study

See Locations Near You

GSK Investigational Site
Miami Florida, 33136, United States
GSK Investigational Site
Chicago Illinois, 60637, United States
GSK Investigational Site
Zion Illinois, 60099, United States
GSK Investigational Site
Houston Texas, 77030, United States
GSK Investigational Site
Campbelltown New South Wales, 2560, Australia
GSK Investigational Site
Liverpool New South Wales, 2170, Australia
GSK Investigational Site
Randwick New South Wales, 2031, Australia
GSK Investigational Site
South Brisbane Queensland, 4101, Australia
GSK Investigational Site
Bedford Park South Australia, 5042, Australia
GSK Investigational Site
Box Hill Victoria, 3128, Australia
GSK Investigational Site
Ringwood East Victoria, 3128, Australia
GSK Investigational Site
Toronto Ontario, M4N 3, Canada
GSK Investigational Site
Bayonne , 64100, France
GSK Investigational Site
Lille Cedex , 59020, France
GSK Investigational Site
Paris cedex 13 , 75651, France
GSK Investigational Site
Ramat Gan , 52621, Israel
GSK Investigational Site
Auckland , , New Zealand
GSK Investigational Site
Barcelona , 08035, Spain
GSK Investigational Site
Girona , 17007, Spain
GSK Investigational Site
Valencia , 46010, Spain
GSK Investigational Site
Sfax , 3000, Tunisia
GSK Investigational Site
Sfax , 3029, Tunisia
GSK Investigational Site
Tunis , 1004, Tunisia
GSK Investigational Site
Tunis , 1007, Tunisia
GSK Investigational Site
London , SW3 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

49

Study ID:

NCT00111787

Recruitment Status:

Completed

Sponsor:


GlaxoSmithKline

How clear is this clinincal trial information?

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