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A Study of Avastin (Bevacizumab) Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.

NCT00448591 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2296

Last updated 2015-05-25

Study results available
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Summary

This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal doxorubicin) may be used. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Conditions

Interventions

DRUG

bevacizumab [Avastin]

10mg/kg iv on day 1 of each 3 week cycle, or 15mg/kg iv on day 1 of each 2 week cycle

DRUG

Taxane-based chemotherapy

As prescribed

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • Argentina
  • Australia
  • Austria
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Colombia
  • Czechia
  • Ecuador
  • Egypt
  • Estonia
  • Finland
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Latvia
  • Lebanon
  • Lithuania
  • Mexico
  • Morocco
  • Netherlands
  • Poland
  • Portugal
  • Russia
  • Saudi Arabia
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT00448591 on ClinicalTrials.gov