NCT00111787

Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, MUGA/ECHO exams and physical exams will be performed throughout the study to monitor safety.

Conditions

• Neoplasms, Breast

Interventions

Type	Name	Description
DRUG	Lapatinib	Daily-monotherapy \[1500 milligrams (mg)\] for 14 days, then daily combination therapy (with weekly paclitaxel) for 12 weeks
DRUG	Paclitaxel	Weekly (80mg/m\^2) combination therapy (with daily Lapatinib) for 12 weeks

Timeline

• Start date: 2005-04-11
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2005-05-26
• Last updated: 2017-05-31

Locations

25 sites across 9 countries: United States, Australia, Canada, France, Israel, New Zealand, Spain, Tunisia, United Kingdom