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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.
Information provided by:
GlaxoSmithKline Identifier:
First received: May 25, 2005
Last updated: October 1, 2010
Last verified: October 2010
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.

Condition Intervention Phase
Breast Cancer
Newly Diagnosed
ErbB2 Overexpressing
ErbB1 Expressing
Drug: Lapatinib
Drug: Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Pathologic Complete Response

Secondary Outcome Measures:
  • Objective Response Rate (complete response plus partial response)

Estimated Enrollment: 60
Study Start Date: April 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Lapatinib Drug: Paclitaxel
    Other Name: Lapatinib

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00111787

  Hide Study Locations
United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33136
United States, Illinois
GSK Investigational Site
Aurora, Illinois, United States, 60506
GSK Investigational Site
Chicago, Illinois, United States, 60637
GSK Investigational Site
Zion, Illinois, United States, 60099
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77030
Australia, New South Wales
GSK Investigational Site
Campbelltown, New South Wales, Australia, 2560
GSK Investigational Site
Liverpool, New South Wales, Australia, 2170
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
Australia, Queensland
GSK Investigational Site
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
GSK Investigational Site
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
GSK Investigational Site
Box Hill, Victoria, Australia, 3128
GSK Investigational Site
Ringwood East, Victoria, Australia, 3128
Canada, Ontario
GSK Investigational Site
Toronto, Ontario, Canada, M4N 3M5
GSK Investigational Site
Bayonne, France, 64100
GSK Investigational Site
Lille Cedex, France, 59020
GSK Investigational Site
Paris cedex 13, France, 75651
GSK Investigational Site
Ramat Gan, Israel, 52621
New Zealand
GSK Investigational Site
Auckland, New Zealand
GSK Investigational Site
Barcelona, Spain, 08035
GSK Investigational Site
Girona, Spain, 17007
GSK Investigational Site
Valencia, Spain, 46010
GSK Investigational Site
Sfax, Tunisia, 3000
GSK Investigational Site
Sfax, Tunisia, 3029
GSK Investigational Site
Tunis, Tunisia, 1004
GSK Investigational Site
Tunis, Tunisia, 1007
United Kingdom
GSK Investigational Site
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Responsible Party: Study Director, GSK Identifier: NCT00111787     History of Changes
Other Study ID Numbers: EGF102580
Study First Received: May 25, 2005
Last Updated: October 1, 2010

Keywords provided by GlaxoSmithKline:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Inflammatory Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors processed this record on May 23, 2017