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

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

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, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

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

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

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	EGF30001
First Received:	January 7, 2004
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00075270
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

Study placed in the following topic categories:

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 November 20, 2008

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