Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer
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.
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
- Enrollment
- 580 participants
Conditions and interventions
Conditions
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
- Dec 31, 2003
- Primary completion
- Sep 30, 2006
- Completion
- Feb 29, 2012
- Last update posted
- May 5, 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 5, 2015 · Synced Sep 16, 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 protocol, eligibility criteria, and contact information for NCT00075270 live on ClinicalTrials.gov.