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Trastuzumab in Combination With Vinorelbine or Taxane-Based Chemotherapy in Patients With Metastatic Breast Cancer

NCT00146549 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2009-11-02

No results posted yet for this study

Summary

The purpose of this study is to compare two different combinations of chemotherapy with trastuzumab as initial treatment for HER2 positive advanced breast cancer. Half of the patients will receive trastuzumab in combination with a taxane form of chemotherapy (either paclitaxel or docetaxel), while the other group will receive trastuzumab in combination with vinorelbine.

Conditions

Interventions

DRUG

Trastuzumab

DRUG

Vinorelbine

DRUG

Paclitaxel

DRUG

Docetaxel

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Brigham and Women's Hospital

    collaborator OTHER

  • North Shore Medical Center

    collaborator OTHER

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Dana-Farber Cancer Institute

    lead OTHER

Principal Investigators

  • Harold Burstein, MD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-08-31
Primary Completion
2007-08-31
Completion
2007-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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 NCT00146549 on ClinicalTrials.gov