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
- 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).
- 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:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathologic Complete Response
GSK Clinical Trials, MD
United States: Food and Drug Administration
- Breast Cancer
- Newly Diagnosed
- ErbB2 Overexpressing
- ErbB1 Expressing
- breast cancer
- Breast Neoplasms
- Inflammatory Breast Neoplasms
|GSK Investigational Site||Gainesville, Florida 32610|
|GSK Investigational Site||Fort Worth, Texas 76104|
|GSK Investigational Site||Park Ridge, Illinois 60068|