MedTrace Logo

Bevacizumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER-2/NEU

NCT00520975 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-03-28

Study results available
· View outcomes & findings →

Summary

This randomized phase III trial studies first-line chemotherapy and trastuzumab to compare how well they work when given with or without bevacizumab in treating patients with breast cancer that overexpresses human epidermal growth factor receptor 2 (HER-2/NEU) and has spread to other areas of the body. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab and bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of breast cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether giving first-line chemotherapy together with trastuzumab is more effective with or without bevacizumab in treating patients with metastatic breast cancer that overexpresses HER-2/NEU.

Conditions

  • Breast Carcinoma
  • Recurrent Breast Carcinoma
  • Stage IV Breast Cancer

Interventions

BIOLOGICAL

Bevacizumab

Given IV

DRUG

Carboplatin

Given IV

DRUG

Paclitaxel

Given IV

OTHER

Placebo

Given IV

BIOLOGICAL

Trastuzumab

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Ingrid Mayer · ECOG-ACRIN Cancer Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00520975 on ClinicalTrials.gov