Trastuzumab (Herceptin), Bevacizumab, and Docetaxel (Taxotere) Trial in Stage IV Metastatic Breast Cancer (MBC) Patients

Arms (1)

1. type

   EXPERIMENTAL

   label

   Trastuzumab, Bevacizumab, and Docetaxel

   description

   Trastuzumab \[6mg/kg\], Bevacizumab \[15mg/kg\], and Docetaxel \[75 mg/M²\]

   interventionNames

   1. Drug: Trastuzumab
   2. Drug: Bevacizumab
   3. Drug: Docetaxel

Primary outcomes (1)

1. measure

   Progression-free Survival (PFS) and to Evaluate Safety of the Trastuzumab, Bevacizumab and Docetaxel Regimen.

   timeFrame

   up to 3 years

   description

   The trial was designed as a single-stage phase II rather then usual two-stage design because of the progression free survival (PFS) primary endpoint, as it is impractical to wait to assess PFS for patients in the first stage. We will consider a PFS of 50% at twelve months (median PFS of 12 months) or less uninteresting and a PFS of 70% at twelve months (median PFS of twenty months) worthy of pursuing the regimen in a future trials. The single-stage design is as follows: p0=0.50, p1=0.70, α=0.10, β= 0.10. This leads to a total sample size of 39 patients, 24 or higher of who are progression-free at 12 months.