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Lapatinib In Combination With Trastuzumab Versus Lapatinib Monotherapy In Subjects With HER2-positive Metastatic Breast Cancer

NCT00320385 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 296

Last updated 2016-02-26

Study results available
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Summary

This study will evaluate and compare the safety and efficacy of lapatinib in combination with trastuzumab versus lapatinib monotherapy in subjects with HER2-positive metastatic breast cancer.

Conditions

  • Neoplasms, Breast

Interventions

DRUG

Lapatinib

oral lapatinib once daily

BIOLOGICAL

Trastuzumab

IV trastuzumab 2mg/kg weekly after 4mg/kg loading dose

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2007-06-30
Completion
2010-10-31

Countries

  • United States
  • Austria
  • Bulgaria
  • Canada
  • Croatia
  • Czechia
  • Finland
  • Germany
  • Greece
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00320385 on ClinicalTrials.gov