CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 494 enrolled
Drug / intervention
bevacizumab [Avastin] +1 moredrug
Likely dose
bevacizumab [Avastin] 10 mgfrom 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/NCT01250379
NCT01250379Phase 3Completed

A Phase III Randomized Study Evaluating the Efficacy and Safety of Continued and Re-induced Bevacizumab in Combination With Chemotherapy for Patients With Locally Recurrent or Metastatic Breast Cancer After First-line Chemotherapy and Bevacizumab Treatment

Hoffmann-La Roche·interventional·Posted Nov 30, 2010·Updated Feb 11, 2016

In Brief

A Phase 3 clinical trial evaluating bevacizumab [Avastin] and Chemotherapy for Breast Cancer. Completed, enrolled 494 participants across 132 sites in 13 countries.

Detailed Summary

This randomized, open-label, parallel-group study will assess the efficacy and s afety of Avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second- and third-line therapy in patients with locally recurrent o r metastatic breast cancer progressing after first-line therapy with Avastin and chemotherapy. Patients will be randomized to receive either Avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks intravenously) plus standard chemotherapy or chemotherapy alone. Anticipated time on study treatment is until third-line disease progression or unacceptable toxicity occurs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesArgentina, Austria, Brazil, Croatia, France, Germany, Greece, Hungary, Israel, Italy, Slovakia, Spain, Switzerland
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 30, 2010
Enrollment StartFeb 1, 2011
Primary CompletionDec 1, 2013
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 15.6 years ago

Interventions

bevacizumab [Avastin]drug

10 mg/ kg iv every 2 weeks or 15 mg/kg iv every 3 weeks

Chemotherapydrug

Standard chemotherapy (doublets not allowed)