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Efficacy Study of Single Agent Trastuzumab or Lapatinib to Treat HER2-Overexpressing Breast Cancer

NCT00842998 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2009-06-26

No results posted yet for this study

Summary

This study will evaluate the activity of single agent trastuzumab or lapatinib in patients not previously treated for HER-2 positive (FISH positive) metastatic breast cancer. A companion biological study will assess factors correlated with sensitivity or resistance to either one of the compounds

Conditions

Interventions

DRUG

Trastuzumab or Lapatinib

Trastuzumab: loading dose 8 mg/kg iv in 90 min.followed by weekly doses of 2 mg/kg Lapatinib: 1500 mg/die orally

Sponsors & Collaborators

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    lead OTHER

Principal Investigators

  • Massimo Aglietta, Full Professor, MD · University of Turin Medical School at AO Ordine Mauriziano di Torino

  • Filippo Montemurro, MD · AO Ordine Mauriziano di Torino

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT00842998 on ClinicalTrials.gov