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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
  Purpose

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
Inflammatory
 Drug: Lapatinib
Drug: Paclitaxel
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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 Names:
    • Lapatinib
    • Paclitaxel
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00111787

  Hide Study Locations
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
France
GSK Investigational Site
Bayonne, France, 64100
GSK Investigational Site
Lille Cedex, France, 59020
GSK Investigational Site
Paris cedex 13, France, 75651
Israel
GSK Investigational Site
Ramat Gan, Israel, 52621
New Zealand
GSK Investigational Site
Auckland, New Zealand
Spain
GSK Investigational Site
Barcelona, Spain, 08035
GSK Investigational Site
Girona, Spain, 17007
GSK Investigational Site
Valencia, Spain, 46010
Tunisia
GSK Investigational Site
Sfax, Tunisia, 3000
GSK Investigational Site
Sfax, Tunisia, 3029
GSK Investigational Site
Tunis, Tunisia, 1007
GSK Investigational Site
Tunis, Tunisia, 1004
United Kingdom
GSK Investigational Site
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00111787     History of Changes
Other Study ID Numbers: EGF102580
Study First Received: May 25, 2005
Last Updated: October 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Inflammatory Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Lapatinib
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013