Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00111787

Purpose

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.

Condition	Intervention	Phase
Breast Cancer Newly Diagnosed ErbB2 Overexpressing ErbB1 Expressing Inflammatory	Drug: Lapatinib Drug: Paclitaxel	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel Lapatinib Lapatinib Ditosylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Pathologic Complete Response

Secondary Outcome Measures:

Objective Response Rate (complete response plus partial response)

Estimated Enrollment:	60
Study Start Date:	April 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111787

Show 26 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	EGF102580
Study First Received:	May 25, 2005
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00111787
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

breast cancer

Study placed in the following topic categories:

Inflammatory breast cancer
Skin Diseases
Paclitaxel

Breast Neoplasms
Lapatinib
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators

Tubulin Modulators
Enzyme Inhibitors
Antimitotic Agents
Protein Kinase Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009