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A Study of Bevacizumab (Avastin) in Women With HER2 Negative Metastatic Breast Cancer

NCT00333775 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 736

Last updated 2016-01-27

Study results available
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Summary

This study will evaluate the efficacy and safety of 2 doses of Avastin in combination with docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast cancer who are candidates for taxane-based chemotherapy but who have not received prior chemotherapy for metastatic disease. The anticipated time on treatment is 1-2 years and the target sample size is 500+ individuals.

Conditions

Interventions

DRUG

Docetaxel

Docetaxel was supplied in 2 vials, 1 containing docetaxel and 1 containing a solvent, for intravenous infusion.

DRUG

Placebo to bevacizumab

Placebo to bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.

DRUG

Bevacizumab

Bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2007-10-31
Completion
2013-10-31

Countries

  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • China
  • France
  • Germany
  • Italy
  • Lithuania
  • Mexico
  • Netherlands
  • Panama
  • Poland
  • Portugal
  • Romania
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT00333775 on ClinicalTrials.gov