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Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00111787
First received: May 25, 2005
Last updated: October 1, 2010
Last verified: October 2010
History of Changes

May 25, 2005
October 1, 2010
April 2005
November 2006   (final data collection date for primary outcome measure)
Pathologic Complete Response
Not Provided
Complete list of historical versions of study NCT00111787 on ClinicalTrials.gov Archive Site
Objective Response Rate (complete response plus partial response)
Not Provided
Not Provided
Not Provided
 
Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer
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

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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Newly Diagnosed
  • ErbB2 Overexpressing
  • ErbB1 Expressing
  • Inflammatory
  • Drug: Lapatinib
  • Drug: Paclitaxel
    Other Names:
    • Lapatinib
    • Paclitaxel
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2006
November 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   France,   Israel,   New Zealand,   Spain,   Tunisia,   United Kingdom
 
NCT00111787
EGF102580
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP