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Paclitaxel With or Without Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Breast Cancer

NCT00028990 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 722

Last updated 2023-06-15

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. It is not yet known whether paclitaxel works better with or without bevacizumab in treating breast cancer.

PURPOSE: This randomized phase III trial is to see if paclitaxel works better with or without bevacizumab in treating patients who have locally recurrent or metastatic breast cancer.

Conditions

Interventions

DRUG

bevacizumab

10 mg/kg following paclitaxel treatment on weeks 1 and 3 of every 4-week cycle

DRUG

Paclitaxel

90 mg/m2 IV infusion over 1 hour every week for 3 weeks followed by 1 week rest

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • North Central Cancer Treatment Group

    collaborator NETWORK

  • NCIC Clinical Trials Group

    collaborator NETWORK

  • NSABP Foundation Inc

    collaborator NETWORK

  • Eastern Cooperative Oncology Group

    lead NETWORK

Principal Investigators

  • Kathy Miller, MD · Indiana University Melvin and Bren Simon Cancer Center

  • Robin Zon, MD · Elkhart General Hospital

  • Edith A. Perez, MD · Mayo Clinic

  • Tamara N. Shenkier, MD · British Columbia Cancer Agency

  • Melody A. Cobleigh, MD · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-29
Primary Completion
2006-11-30
Completion
2009-05-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

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 NCT00028990 on ClinicalTrials.gov