283
Participants
Start Date
January 31, 2011
Primary Completion Date
July 31, 2014
Study Completion Date
July 31, 2014
PRO Onc Assay and Treatment
Patients with HER2-negative metastatic breast cancer will be identified, and blood specimens will be obtained from each participant. The PRO Onc Assay will be performed on CTCs isolated from these specimens. When clinically indicated, fine needle aspiration biopsy will also be obtained and submitted for the PRO Onc Assay.
Trastuzumab
8 mg/kg IV loading dose, followed by 6 mg /kg IV every 3 weeks until progressive disease or unacceptable toxicity with evaluations performed every 8 weeks
Pertuzumab
840 mg IV loading dose, followed by 420 IV every 3 weeks until progressive disease or unacceptable toxicity with evaluations performed every 8 weeks
Virginia Cancer Institute, Richmond
Florida Cancer Specialists, St. Petersburg
Florida Cancer Specialists, Fort Myers
Tennessee Oncology, PLLC, Nashville
Chattanooga Oncology Hematology Associates, Chattanooga
Oncology Hematology Care, Inc., Cincinnati
Center for Cancer and Blood Disorders, Fort Worth
Collaborators (2)
Prometheus Laboratories
INDUSTRY
Genentech, Inc.
INDUSTRY
SCRI Development Innovations, LLC
OTHER