CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,296 enrolled
Drug / intervention
bevacizumab [Avastin] +1 moredrug
Likely dose
bevacizumab [Avastin] 10mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00448591
NCT00448591Phase 3Completed

An Open-label Study to Evaluate the Safety and Effect on Disease Progression and Overall Survival of Avastin Plus Taxane-based Chemotherapy in Patients With Locally Recurrent or Metastatic Breast Cancer

Hoffmann-La Roche·interventional·Posted Mar 19, 2007·Updated May 25, 2015

In Brief

A Phase 3 clinical trial evaluating bevacizumab [Avastin] and Taxane-based chemotherapy for Breast Cancer. Completed, enrolled 2,296 participants across 457 sites in 36 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesArgentina, 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
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 19, 2007
Enrollment StartSep 1, 2006
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 19.3 years ago

Interventions

bevacizumab [Avastin]drug

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

Taxane-based chemotherapydrug

As prescribed