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
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Newly Diagnosed, ErbB2 Overexpressing, ErbB1 Expressing, Inflammatory
Both
Breast Cancer, Newly Diagnosed, ErbB2 Overexpressing, ErbB1 Expressing, Inflammatory
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 Site | Gainesville, Florida 32610 |
| GSK Investigational Site | Fort Worth, Texas 76104 |
| GSK Investigational Site | Park Ridge, Illinois 60068 |
