Status:
COMPLETED
Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neoplasms, Breast
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 cance...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 11 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00111787
Start Date
April 11 2005
End Date
November 1 2006
Last Update
May 31 2017
Active Locations (25)
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1
GSK Investigational Site
Miami, Florida, United States, 33136
2
GSK Investigational Site
Chicago, Illinois, United States, 60637
3
GSK Investigational Site
Zion, Illinois, United States, 60099
4
GSK Investigational Site
Houston, Texas, United States, 77030