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Paclitaxel, Nab-paclitaxel, or Ixabepilone With or Without Bevacizumab in Treating Patients With Stage IIIC or Stage IV Breast Cancer

NCT00785291 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 799

Last updated 2022-10-10

Study results available
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Summary

This randomized phase III trial studies the side effects and how well different chemotherapy regimens with or without bevacizumab work in treating patients with stage IIIC or stage IV breast cancer. Drugs used in chemotherapy, such as paclitaxel, paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel), and ixabepilone, 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. Bevacizumab may block tumor growth by targeting certain cells and slowing the growth of blood vessels to the tumor. It is not yet known which treatment regimen is more effective in treating patients with breast cancer.

Conditions

  • Estrogen Receptor Negative
  • Estrogen Receptor Positive
  • HER2/Neu Negative
  • HER2/Neu Positive
  • Progesterone Receptor Negative
  • Progesterone Receptor Positive
  • Recurrent Breast Carcinoma
  • Stage IIIC Breast Cancer AJCC v6
  • Stage IV Breast Cancer AJCC v6 and v7

Interventions

BIOLOGICAL

Bevacizumab

Given IV

DRUG

Ixabepilone

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Nab-paclitaxel

Given IV

DRUG

Paclitaxel

Given IV

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Hope S Rugo · Alliance for Clinical Trials in Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-13
Primary Completion
2013-12-31
Completion
2017-06-15

Countries

  • United States
  • Puerto Rico

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 NCT00785291 on ClinicalTrials.gov