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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00075270

Public ClinicalTrials.gov record NCT00075270. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 3, 2026, 9:24 PM EST

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00075270
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
GlaxoSmithKline
Industry
Enrollment
580 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 2004 (Type not available)
Primary completion
Oct 2006 (Actual)
Completion
Mar 2012 (Actual)
Last update posted
May 6, 2015

2004 – 2012

United States locations

U.S. sites
45
U.S. states
27
U.S. cities
43
Facility City State ZIP Site status
GSK Investigational Site Tucson Arizona 85712 —
GSK Investigational Site Hot Springs Arkansas 71913 —
GSK Investigational Site Jonesboro Arkansas 72401 —
GSK Investigational Site Fountain Valley California 92708 —
GSK Investigational Site La Jolla California 92093-0987 —
GSK Investigational Site Rancho Mirage California 92270 —
GSK Investigational Site Vallejo California 94589 —
GSK Investigational Site Denver Colorado 80218 —
GSK Investigational Site Boca Raton Florida 33486 —
GSK Investigational Site Orlando Florida 32804 —
GSK Investigational Site Port Saint Lucie Florida 34952 —
GSK Investigational Site West Palm Beach Florida 33401 —
GSK Investigational Site Atlanta Georgia 30341 —
GSK Investigational Site Marietta Georgia 30060 —
GSK Investigational Site Savannah Georgia 31405 —
GSK Investigational Site Savannah Georgia 31406 —
GSK Investigational Site Indianapolis Indiana 46260 —
GSK Investigational Site Kansas City Kansas 66160 —
GSK Investigational Site Metairie Louisiana 70006 —
GSK Investigational Site Baltimore Maryland 21201 —
GSK Investigational Site Glen Burnie Maryland 21225 —
GSK Investigational Site Springfield Massachusetts 01199 —
GSK Investigational Site Duluth Minnesota 55802 —
GSK Investigational Site Robbinsdale Minnesota 55422 —
GSK Investigational Site St Louis Missouri 63141 —
GSK Investigational Site Voorhees Township New Jersey 08043 —
GSK Investigational Site Santa Fe New Mexico 87505 —
GSK Investigational Site Nyack New York 10960 —
GSK Investigational Site Syracuse New York 13210 —
GSK Investigational Site Charlotte North Carolina 28203 —
GSK Investigational Site Greenville North Carolina 27834 —
GSK Investigational Site Fargo North Dakota 58103 —
GSK Investigational Site Canton Ohio 44718 —
GSK Investigational Site Portland Oregon 97227 —
GSK Investigational Site Columbia South Carolina 29210 —
GSK Investigational Site Knoxville Tennessee 37916 —
GSK Investigational Site Knoxville Tennessee 37920 —
GSK Investigational Site Amarillo Texas 79106 —
GSK Investigational Site Fort Worth Texas 76104 —
GSK Investigational Site Houston Texas 77054 —
GSK Investigational Site San Antonio Texas 78229 —
GSK Investigational Site Burlington Vermont 05401 —
GSK Investigational Site Norfolk Virginia 23502 —
GSK Investigational Site Tacoma Washington 98405 —
GSK Investigational Site Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 132 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00075270, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 6, 2015 · Synced Nov 3, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00075270 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →