Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer
NCT ID: NCT00111787
Last Updated: 2017-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
49 participants
INTERVENTIONAL
2005-04-11
2006-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Overall study
A Single arm study with 2 cohorts of participants. Cohort A consists of participants with tumors overexpressing HER2 and/or EGFR. Cohort B consists of participants with tumors expressing EGFR without overexpressing HER2.
Lapatinib
Daily-monotherapy \[1500 milligrams (mg)\] for 14 days, then daily combination therapy (with weekly paclitaxel) for 12 weeks
Paclitaxel
Weekly (80mg/m\^2) combination therapy (with daily Lapatinib) for 12 weeks
Interventions
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Lapatinib
Daily-monotherapy \[1500 milligrams (mg)\] for 14 days, then daily combination therapy (with weekly paclitaxel) for 12 weeks
Paclitaxel
Weekly (80mg/m\^2) combination therapy (with daily Lapatinib) for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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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
Countries
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References
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Boussen H, Cristofanilli M, Zaks T, DeSilvio M, Salazar V, Spector N. Phase II study to evaluate the efficacy and safety of neoadjuvant lapatinib plus paclitaxel in patients with inflammatory breast cancer. J Clin Oncol. 2010 Jul 10;28(20):3248-55. doi: 10.1200/JCO.2009.21.8594. Epub 2010 Jun 7.
Other Identifiers
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EGF102580
Identifier Type: -
Identifier Source: org_study_id
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