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Completed Phase 3 Interventional Results available

Lapatinib In Combination With Trastuzumab Versus Lapatinib Monotherapy In Subjects With HER2-positive Metastatic Breast Cancer

ClinicalTrials.gov ID: NCT00320385

Public ClinicalTrials.gov record NCT00320385. 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 Oct 21, 2026, 4:02 PM EDT

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, Open-Label, Phase III Study of Lapatinib in Combination With Trastuzumab Versus Lapatinib Monotherapy in Subjects With HER2-positive Metastatic Breast Cancer Whose Disease Has Progressed on Trastuzumab-Containing Regimens

Brief summary

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

This study will evaluate and compare the safety and efficacy of lapatinib in combination with trastuzumab versus lapatinib monotherapy in subjects with HER2-positive metastatic breast cancer.

Study identification

NCT ID
NCT00320385
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
GlaxoSmithKline
Industry
Enrollment
296 participants

Conditions and interventions

Interventions

Drug · Biological

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
Nov 2005 (Type not available)
Primary completion
Jun 2007 (Actual)
Completion
Oct 2010 (Actual)
Last update posted
Feb 26, 2016

2005 – 2010

United States locations

U.S. sites
87
U.S. states
25
U.S. cities
82
Facility City State ZIP Site status
GSK Investigational Site Phoenix Arizona 85012 —
GSK Investigational Site Sedona Arizona 86336 —
GSK Investigational Site Highland California 92346 —
GSK Investigational Site Sacramento California 95819 —
GSK Investigational Site San Diego California 92120 —
GSK Investigational Site San Francisco California 94115-1710 —
GSK Investigational Site Santa Rosa California 95403-1757 —
GSK Investigational Site Vallejo California 94589 —
GSK Investigational Site Newark Delaware 19713 —
GSK Investigational Site Boca Raton Florida 33428 —
GSK Investigational Site Fort Myers Florida 33916 —
GSK Investigational Site Gainesville Florida 32605 —
GSK Investigational Site Hollywood Florida 33021 —
GSK Investigational Site Jacksonville Florida 32256 —
GSK Investigational Site Miami Florida 33136 —
GSK Investigational Site Ocala Florida 34474 —
GSK Investigational Site Ocoee Florida 34761 —
GSK Investigational Site Orlando Florida 32804 —
GSK Investigational Site West Palm Beach Florida 33401 —
GSK Investigational Site Lawrenceville Georgia 30046-7650 —
GSK Investigational Site Niles Illinois 60714 —
GSK Investigational Site Indianapolis Indiana 46202 —
GSK Investigational Site Indianapolis Indiana 46227 —
GSK Investigational Site Terre Haute Indiana 47802 —
GSK Investigational Site Cedar Rapids Iowa 52403 —
GSK Investigational Site Kansas City Kansas 66103 —
GSK Investigational Site Overland Park Kansas 66210 —
GSK Investigational Site Boston Massachusetts 02115 —
GSK Investigational Site Minneapolis Minnesota 55404 —
GSK Investigational Site Robbinsdale Minnesota 55422 —
GSK Investigational Site Columbia Missouri 65201 —
GSK Investigational Site Saint Joseph Missouri 64507 —
GSK Investigational Site Las Vegas Nevada 89109 —
GSK Investigational Site Las Vegas Nevada 89135 —
GSK Investigational Site Montclair New Jersey 07042 —
GSK Investigational Site Morristown New Jersey 07962 —
GSK Investigational Site New Brunswick New Jersey 08901 —
GSK Investigational Site Summit New Jersey 07901 —
GSK Investigational Site Voorhees Township New Jersey 08043 —
GSK Investigational Site Albany New York 12208 —
GSK Investigational Site New York New York 10016 —
GSK Investigational Site Cary North Carolina 27511 —
GSK Investigational Site Charlotte North Carolina 28203 —
GSK Investigational Site Durham North Carolina 27710 —
GSK Investigational Site Hickory North Carolina 28602 —
GSK Investigational Site Canton Ohio 44710 —
GSK Investigational Site Kettering Ohio 45409 —
GSK Investigational Site Oklahoma City Oklahoma 73112 —
GSK Investigational Site Tulsa Oklahoma 74136-1902 —
GSK Investigational Site Bryn Mawr Pennsylvania 19010 —
GSK Investigational Site Hershey Pennsylvania 17033 —
GSK Investigational Site Kingston Pennsylvania 18704 —
GSK Investigational Site Philadelphia Pennsylvania 19104 —
GSK Investigational Site Pittsburgh Pennsylvania 15213 —
GSK Investigational Site West Reading Pennsylvania 19611 —
GSK Investigational Site Greenville South Carolina 29605 —
GSK Investigational Site Nashville Tennessee 37203 —
GSK Investigational Site Arlington Texas 76014 —
GSK Investigational Site Austin Texas 78731 —
GSK Investigational Site Beaumont Texas 77702-1449 —
GSK Investigational Site Bedford Texas 76022 —
GSK Investigational Site Dallas Texas 75230 —
GSK Investigational Site Dallas Texas 75231 —
GSK Investigational Site Dallas Texas 75237 —
GSK Investigational Site Dallas Texas 75246 —
GSK Investigational Site Denton Texas 76210 —
GSK Investigational Site El Paso Texas 79915 —
GSK Investigational Site Fort Worth Texas 76104 —
GSK Investigational Site Fredericksburg Texas 78624 —
GSK Investigational Site Lewisville Texas 75067 —
GSK Investigational Site Longview Texas 75601 —
GSK Investigational Site McAllen Texas 78503-1298 —
GSK Investigational Site Mesquite Texas 75150 —
GSK Investigational Site Midland Texas 79701 —
GSK Investigational Site Odessa Texas 79761 —
GSK Investigational Site Paris Texas 75460 —
GSK Investigational Site Tyler Texas 75702 —
GSK Investigational Site Waco Texas 76712 —
GSK Investigational Site Norfolk Virginia 23502 —
GSK Investigational Site Richmond Virginia 23230 —
GSK Investigational Site Salem Virginia 24153 —
GSK Investigational Site Edmonds Washington 98026 —
GSK Investigational Site Seattle Washington 98133 —
GSK Investigational Site Spokane Washington 99202 —
GSK Investigational Site Vancouver Washington 98684 —
GSK Investigational Site Yakima Washington 98902 —
GSK Investigational Site Green Bay Wisconsin 54301 —

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 58 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00320385, 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 Feb 26, 2016 · Synced Oct 21, 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 NCT00320385 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →