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Vinorelbine With or Without Trastuzumab in Treating Women With Progressive Metastatic Breast Cancer

NCT00103233 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2013-06-24

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Trastuzumab may also help vinorelbine work better by making tumor cells more sensitive to the drug. Giving vinorelbine together with trastuzumab may be an effective treatment for breast cancer. It is not yet known whether giving vinorelbine together with trastuzumab is more effective than vinorelbine alone in treating breast cancer.

PURPOSE: This randomized phase III trial is studying vinorelbine and trastuzumab to see how well they work compared to vinorelbine alone in treating women with progressive metastatic breast cancer.

Conditions

Interventions

BIOLOGICAL

trastuzumab

DRUG

vinorelbine tartrate

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Lajos Pusztai, MD, MPH, DPhil · M.D. Anderson Cancer Center

  • Francisco J. Esteva, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Completion
2006-04-30

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Entities

Drugs
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 NCT00103233 on ClinicalTrials.gov