CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,591 enrolled
Drug / intervention
Bevacizumab +1 moredrug
Likely dose
Bevacizumab 5 mg/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/NCT00528567
NCT00528567Phase 3Completed
CompareCT.gov

An International Multi-centre Open-label 2-arm Phase III Trial of Adjuvant Bevacizumab in "Triple Negative" Breast Cancer.

Hoffmann-La Roche·interventional·Posted Sep 12, 2007·Updated Sep 4, 2015

In Brief

A Phase 3 clinical trial evaluating Bevacizumab and Standard adjuvant chemotherapy for Breast Cancer. Completed, enrolled 2,591 participants across 403 sites in 40 countries.

Detailed Summary

The main objective of the trial is to compare Invasive Disease-Free Survival (IDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy with 1 year of bevacizumab. The secondary objectives of this trial are to: * compare Overall Survival (OS), Breast Cancer-Free Interval (BCFI), Disease- Free Survival (DFS) and Distant Disease-Free Survival (DDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy in combination with 1 year of bevacizumab * evaluate the safety and tolerability of bevacizumab An exploratory sub-study (not reported here) was to identify biomarkers (from tumour or serum) predictive of toxicity and for the level of benefit from the addition of bevacizumab to standard adjuvant systemic treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesArgentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Costa Rica, Czechia, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, North Macedonia, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2007
Enrollment StartDec 1, 2007
Primary CompletionFeb 1, 2012
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 18.8 years ago

Interventions

Bevacizumabdrug

Bevacizumab was administered at a dose equivalent of 5 mg/kg/week using 1 of 3 different scheduling options depending on the schedule of the adjuvant chemotherapy regimen selected for an individual patient.

Standard adjuvant chemotherapydrug

All chemotherapy schedules and doses for each patient were prescribed according to the labeled indication of the country in which the patient was receiving therapy.