Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111787
Status:
COMPLETED
Last Update Posted:
2017-05-31
First Post:
2005-05-25
Brief Title:
Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 MUGAECHO exams and physical exams will be performed throughout the study to monitor safety
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None