A Phase II Study of Abraxane, Bevacizumab and Gemcitabine for First Line Metastatic Breast Cancer
- To determine preliminary evidence of efficacy of the combination regimen of gemcitabine
hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®), and
bevacizumab as first-line treatment for Her2/neu-negative metastatic (stage IV) breast
- To determine the partial, complete, and overall response rate.
- To determine the safety and side effect profile of the treatment combination.
- To explore the relationship between circulating tumor cells (CTC) and disease
progression, by measuring CTC at baseline and over the course of treatment.
OUTLINE: Patients receive gemcitabine hydrochloride IV over 30 minutes followed by
paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®) IV over 30 minutes
followed by bevacizumab IV over 30 minutes on days 1 and 15. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
Patients undergo tumor tissue and blood sample collection periodically for correlative
laboratory studies. Tumor tissue samples are analyzed for secreted protein acidic rich in
cysteine (SPARC) expression by antibody immunostaining. Blood samples are analyzed for the
presence of circulating tumor cells by the CellSearch™ system.
After completion of study treatment, patients are followed at 1 year and then annually
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival will be measured from the first dose date to the earliest date of documented evidence of progressive disease or the date of death due to any causes, whichever occurs first.
Stefan Gluck, MD, PhD, FRCPC
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
|University of Miami Sylvester Comprehensive Cancer Center - Miami||Miami, Florida 33136|