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Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in ErbB2 (HER2) Positive Metastatic Breast Cancer

NCT00820222 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2019-04-02

Study results available
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Summary

This open label study was designed to evaluate Lapatinib effect on incidence of brain metastases in ErbB2 (HER2) positive metastatic breast cancer patients exposed to prior taxanes or anthracyclines.

Conditions

  • Metastases, Brain

Interventions

DRUG

capecitabine

oral medication; daily dose divided into morning and evening dose and taken for 14 days of 21 day cycle

DRUG

lapatinib

oral medication; daily dose taken once a day

DRUG

trastuzumab

infusion therapy; loading dose of 8mg/kg, followed by 6mg/kg given every 3 weeks

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-14
Primary Completion
2012-06-11
Completion
2018-03-22
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Poland
  • Russia
  • Spain
  • Sweden
  • Thailand
  • 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 NCT00820222 on ClinicalTrials.gov