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NCT00379509 · ClinicalTrials.gov registry record · Phase 1

Lapatinib and Radiation Therapy in Treating Patients With Locally Recurrent or Chemotherapy-Refractory Locally Advanced or Metastatic Breast Cancer

A Phase 1 study of Breast Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target
1
Study location

NCT00379509 is a Phase 1 study of Breast Cancer that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 20 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00379509, a Phase 1 study of Breast Cancer, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving lapatinib together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib when given together with radiation therapy in treating patients with locally recurrent or chemotherapy-refractory locally advanced or metastatic breast cancer.

Conditions Studied

Interventions

  • GENETIC gene expression analysis
  • GENETIC microarray analysis
  • OTHER immunohistochemistry staining method
  • DRUG lapatinib ditosylate
  • GENETIC TdT-mediated dUTP nick end labeling assay

Study Locations (1)

North Carolina

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill - Chapel Hill

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2006-04
Est. Completion 2012-08
Phase Phase 1

What the Registry Record Tells You About NCT00379509

The ClinicalTrials.gov registry entry for NCT00379509 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which gene expression analysis is the first listed.

NCT00379509 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT00379509 about?

NCT00379509 is a clinical study titled "Lapatinib and Radiation Therapy in Treating Patients With Locally Recurrent or Chemotherapy-Refractory Locally Advanced or Metastatic Breast Cancer". RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving lapatinib together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side...

What is the current status of trial NCT00379509?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2006-04. Estimated completion is 2012-08.

What conditions does trial NCT00379509 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT00379509?

The interventions under investigation include: gene expression analysis (GENETIC), microarray analysis (GENETIC), immunohistochemistry staining method (OTHER), lapatinib ditosylate (DRUG), TdT-mediated dUTP nick end labeling assay (GENETIC).

Who is sponsoring clinical trial NCT00379509?

This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00379509 being conducted?

This trial has 1 study location across North Carolina. 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 Editorial

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.