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NCT00075270 · ClinicalTrials.gov registry record · Phase 3
Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer
A Phase 3 study of Neoplasms, Breast, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 580
- Enrollment target
- 20
- Study locations
NCT00075270: Completed Phase 3 study of Neoplasms, Breast, sponsored by GlaxoSmithKline.
NCT00075270 is a Phase 3 study of Neoplasms, Breast that has completed, run by GlaxoSmithKline. The registered enrollment target is 580 participants, below the 1,003-participant average among 9 other Neoplasms, Breast trials with a reported enrollment target (42% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00075270, a Phase 3 study of Neoplasms, Breast, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 580 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Time to progression (TTP) is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to breast cancer. The investigator assessed PD based on radiological PD (imaging data) and clinical symptomatic progress (Response Evaluation Criteria in Solid Tumors \[RECIST\] Criteria: target lesion (TL), at least a 20% increase in the sum of largest diameter (LD) of TLs or the appearance of one or more new lesions; non-TL (NTL), the appearan
Conditions Studied
Interventions
- DRUG Paclitaxel
- DRUG GW572016 (Lapatinib)
Study Locations (20)
California
- GSK Investigational Site - Fountain Valley
- GSK Investigational Site - La Jolla
- GSK Investigational Site - Rancho Mirage
- GSK Investigational Site - Vallejo
Florida
- GSK Investigational Site - Boca Raton
- GSK Investigational Site - Orlando
- GSK Investigational Site - Port Saint Lucie
- GSK Investigational Site - West Palm Beach
Georgia
- GSK Investigational Site - Atlanta
- GSK Investigational Site - Marietta
- GSK Investigational Site - Savannah
- GSK Investigational Site - Savannah
Arkansas
- GSK Investigational Site - Hot Springs
- GSK Investigational Site - Jonesboro
Arizona
- GSK Investigational Site - Tucson
Colorado
- GSK Investigational Site - Denver
Indiana
- GSK Investigational Site - Indianapolis
Kansas
- GSK Investigational Site - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 580 participants |
| Start Date | 2004-01 |
| Est. Completion | 2012-03 |
| Phase | Phase 3 |
What the finished NCT00075270 record still lists
NCT00075270 is an interventional study that assigns participants to a tested intervention. The registered 580 participants enrollment target is mid-sized for trials with a published cap, below the 1,003-participant average among 9 other Neoplasms, Breast trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Neoplasms, Breast appearing as the primary indexed condition, and to 2 interventions - of which Paclitaxel is the first listed.
NCT00075270 names 20 study sites across 10 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT00075270 about?
NCT00075270 is a clinical study titled "Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer". 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.
What is the current status of trial NCT00075270?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 580 participants. The study started on 2004-01. Estimated completion is 2012-03.
What conditions does trial NCT00075270 study?
This clinical trial studies the following conditions: Neoplasms, Breast.
What interventions are being tested in trial NCT00075270?
The interventions under investigation include: Paclitaxel (DRUG), GW572016 (Lapatinib) (DRUG).
Who is sponsoring clinical trial NCT00075270?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00075270 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00075270's enrollment target sits among peer trials
580 2nd of 9 the highest of 9 other Neoplasms, Breast trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms, Breast trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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