Trial intelligence / Profile preview

AVADO: Bevacizumab + Docetaxel in HER2- Metastatic Breast Cancer

NCT00333775Phase 3

Key facts

Status
Completed
Start
Mar 2006
Primary completion
Oct 2007
Countries
24
Sponsor
Roche
Modality
Monoclonal Antibodies
Conditions
breast cancer
01

Overview

Phase 3, randomised, double-blind trial of bevacizumab in breast cancer (3 arms), sponsored by Roche. Primary endpoint: Progression-free Survival up to 2.5 years. Started Mar 2006; status: completed.

02

Design

3 arms
Study design
RandomizedDouble-blind
  • Docetaxel + Placebo

    Docetaxel 100 mg/m2 + Placebo q3w

  • Docetaxel + Bevacizumab 7.5

    Docetaxel 100 mg/m2 + Bevacizumab 7.5 mg/kg q3w

  • Docetaxel + Bevacizumab 15

    Docetaxel 100 mg/m2 + Bevacizumab 15.0 mg/kg q3w

03

Who it enrols

Female patients >= 18 years with HER2-negative metastatic or locally recurrent breast cancer suitable for chemotherapy, ECOG 0-1, no prior chemotherapy for metastatic disease.

04

Endpoints

Primary

  • Progression-free Survival

Secondary

  • Objective Response Rate

  • Duration of Response

  • Time to Treatment Failure

  • Overall Survival

05

Results

Primary endpoints met

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