A Prospective Randomized Phase II Study to Identify Predictive Biomarkers and Mechanisms of Therapy Resistance in Patients With HER2-negative Metastatic Breast Cancer Treated With the Combination of Bevacizumab and Paclitaxel (BEVPAC).
This is a prospective, randomized, 2-arm, open-label, single-center, phase II trial. A total
of 30 patients will be included during a period of 2 years.
The study will be initiated with a non-randomized, feasibility stage including ten patients
who will be treated with bevacizumab and paclitaxel, in order to determine the safety of
metastatic tumor biopsies during therapy with bevacizumab.
In the second phase, patients will be randomized (1:1) between two treatment arms: A.
Bevacizumab + paclitaxel and B. Paclitaxel
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Identification of molecular biomarkers
To explore molecular biomarkers and/or gene expression signatures that predict response to bevacizumab given in combination with paclitaxel as first line therapy in HER2 negative MBC.
After the study completion,After completion of the study, which will take up to 3 years
Theodoros Foukakis, MD PhD
Karolinska University Hospital
Sweden: Medical Products Agency
EudraCT no: 2012-003743-30