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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Newly Diagnosed, ErbB2 Overexpressing, ErbB1 Expressing, Inflammatory

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Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic Complete Response

Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

EGF102580

NCT ID:

NCT00111787

Start Date:

April 2005

Completion Date:

November 2006

Related Keywords:

  • Breast Cancer
  • Newly Diagnosed
  • ErbB2 Overexpressing
  • ErbB1 Expressing
  • Inflammatory
  • breast cancer
  • Breast Neoplasms
  • Inflammatory Breast Neoplasms

Name

Location

GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SitePark Ridge, Illinois  60068