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

Tracking Information

First Received Date ^ICMJE

January 7, 2004

Last Updated Date

December 23, 2008

Start Date ^ICMJE

January 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00075270 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Metastatic Breast Cancer

Intervention ^ICMJE

Drug: Paclitaxel
Drug: GW572016 (Lapatinib)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

570

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Czech Republic, Germany, Hungary, Italy, Korea, Republic of, Latvia, Mexico, Netherlands, New Zealand, Pakistan, Peru, Poland, Russian Federation, Slovakia, South Africa, Spain, Turkey

Administrative Information

NCT ID ^ICMJE

NCT00075270

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

EGF30001

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP