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

Completed · Phase 2

Conditions studied: Neoplasms, Breast

In brief

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.

Key facts

Study ID

NCT00111787

Run by

GlaxoSmithKline

People needed

49

Starts

2005-04-11

Expected to finish

2006-11-01

Last updated by the study team

2017-05-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• 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, France
• GSK Investigational Site — Paris, 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

Full record on ClinicalTrials.gov

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