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COMPLETED Phase 3

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

NCT00075270 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 580 participants
Start Date 2004-01
Est. Completion 2012-03
Phase Phase 3

Sponsor

GlaxoSmithKline

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00075270

The ClinicalTrials.gov registry entry for NCT00075270 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 580 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00075270 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00075270?

The interventions under investigation include: Paclitaxel (DRUG), GW572016 (Lapatinib) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00075270?

This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial