Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer

This study has been completed.

First Received: January 7, 2004 Last Updated: December 23, 2008 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00075270

Purpose

The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in first line advanced or metastatic breast cancer.

Condition	Intervention	Phase
Metastatic Breast Cancer	Drug: Paclitaxel Drug: GW572016 (Lapatinib)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Phase III Study of Oral GW572016 in Combination With Paclitaxel in Subjects Previously Untreated or Advanced or Metastatic Breast Cancer

Resource links provided by NLM:

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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

To evaluate and compare the 2 treatment groups with respect to time to progression (TTP) in subjects with metastatic breast cancer.

Secondary Outcome Measures:

Compare the following data between the 2 treatment groups: Tumor Response Clinical Benefit Time to Response Duration of Response Survival Rate Toxicity Biomarker Signals

Enrollment:	570
Study Start Date:	January 2004

Eligibility

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

Criteria

Inclusion criteria:

Signed Informed Consent
Able to swallow an oral medication
Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram
Adequate kidney and liver function
Adequate bone marrow function
Tumor tissue available for testing
Prior adjuvant or neoadjuvant therapy is permitted with an anthracycline or anthracenedione-containing regimen however, subjects must have had cumulative doses of less than 360 mg/m2 of doxorubicin, 720 mg/m2 of epirubicin, or 72 mg/m2 of mitoxantrone
No Her2/neu overexpression in tumor tissue tested or status unknown if tissue has never been tested

Exclusion criteria:

Prior treatment regimens for advanced or metastatic breast cancer.
Pregnant or lactating
Conditions that would effect the absorption of an oral drug
Active infection
Brain metastases
Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor.
Known hypersensitivity to Taxol or excipients of Taxol
Peripheral neuropathy of Grade 2 or greater is not permitted
Severe Cardiovascular disease or cardiac disease requiring a device.
Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075270

Show 146 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	EGF30001
Study First Received:	January 7, 2004
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00075270 History of Changes
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:

lapatinib
metastatic breast cancer
EGFR
Her2-neu

ErbB1
ErbB2
kinase inhibitor

Additional relevant MeSH terms:

Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Breast Neoplasms
Enzyme Inhibitors
Lapatinib
Antimitotic Agents
Protein Kinase Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Breast Diseases

ClinicalTrials.gov processed this record on March 18, 2010