A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.

Arms (2)

1. type

   EXPERIMENTAL

   label

   1

   interventionNames

   1. Drug: bevacizumab [Avastin]
   2. Drug: Docetaxel
   3. Drug: Herceptin

2. type

   ACTIVE_COMPARATOR

   label

   2

   interventionNames

   1. Drug: Docetaxel
   2. Drug: Herceptin

Primary outcomes (1)

1. measure

   Progression Free Survival (PFS)

   timeFrame

   Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)

   description

   PFS was defined as the time from randomization to time of first documented disease progression (unequivocal progression of existing non-target lesions) or death, whichever occurred first as assessed by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0). Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. Primary PFS variable was defined based on the investigators' assessments and the statistical conclusions on the primary efficacy endpoint were based on investigator assessed PFS. PFS was estimated using Kaplan-Meier methods.