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NCT00089999 · ClinicalTrials.gov registry record · Phase 2

Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer

A Phase 2 study of Neoplasms, Breast, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
138
Enrollment target
20
Study locations

NCT00089999 is a Phase 2 study of Neoplasms, Breast that has completed, run by GlaxoSmithKline. The registered enrollment target is 138 participants, below the 1,053-participant average among 9 other Neoplasms, Breast trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 5 states.

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The verdict

NCT00089999, a Phase 2 study of Neoplasms, Breast, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
138 participants
Enrollment target
20
Study locations

Study Summary

This phase II study will evaluate and compare the efficacy and tolerability of two dose schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with advanced or metastatic breast cancer.

Conditions Studied

Neoplasms, Breast

Interventions

  • DRUG Lapatinib

Study Locations (20)

Other

  • GSK Investigational Site - Pokfulam
  • GSK Investigational Site - Delhi
  • GSK Investigational Site - Hyderabad, Andhra Pradesh
  • GSK Investigational Site - Pune
  • GSK Investigational Site - Bandar Tun Razak, Cheras
  • GSK Investigational Site - Kubang Kerian
  • GSK Investigational Site - Tanjong Bungah
  • GSK Investigational Site - Tanjong Bungah
  • GSK Investigational Site - México
  • GSK Investigational Site - Karachi
  • GSK Investigational Site - Karachi
  • GSK Investigational Site - Karachi
  • GSK Investigational Site - Lahore
  • GSK Investigational Site - Rawalpindi

Región Metro de Santiago

  • GSK Investigational Site - Santiago
  • GSK Investigational Site - Santiago
  • GSK Investigational Site - Santiago

Florida

  • GSK Investigational Site - Hollywood

Oaxaca

  • GSK Investigational Site - Ixtaltepec / Espinal

Yucatán

  • GSK Investigational Site - Mérida

Trial Details

FieldValue
Enrollment Target 138 participants
Start Date 2004-06
Est. Completion 2008-03
Phase Phase 2

Sponsor

GlaxoSmithKline

1,345 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00089999

The ClinicalTrials.gov registry entry for NCT00089999 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,053-participant average among 9 other Neoplasms, Breast trials with a reported enrollment target (87% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Neoplasms, Breast appearing as the primary indexed condition, and to 1 intervention - of which Lapatinib is the first listed.

NCT00089999 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Other, Región Metro de Santiago, Florida.

Frequently Asked Questions

What is clinical trial NCT00089999 about?

NCT00089999 is a clinical study titled "Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer". This phase II study will evaluate and compare the efficacy and tolerability of two dose schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with advanced or metastatic breast cancer.

What is the current status of trial NCT00089999?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 138 participants. The study started on 2004-06. Estimated completion is 2008-03.

What conditions does trial NCT00089999 study?

This clinical trial studies the following conditions: Neoplasms, Breast.

What interventions are being tested in trial NCT00089999?

The interventions under investigation include: Lapatinib (DRUG).

Who is sponsoring clinical trial NCT00089999?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00089999 being conducted?

This trial has 20 study locations across Florida, Región Metro de Santiago, Oaxaca, Yucatán. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.