64
Participants
Start Date
March 31, 2011
Primary Completion Date
June 30, 2016
Study Completion Date
June 30, 2017
Abraxane alone
100 mg/m2 weekly X 3 doses (Days 1, 8, 15) at 28-day intervals until disease progression or unacceptable toxicity. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
Abraxane + Tigatuzumab
Tigatuzumab will be administered as a loading dose of 10 mg/kg on Day 1, then 5 mg/kg on Day 15 and then every other week on Days 1 and 15 of subsequent cycles. It will be given as an IV infusion over 60 minutes or less. No dose reductions will be allowed. Tigatuzumab will be administered in combination with the Abraxane according to the intervention described for it.
Memorial Sloan Kettering Cancer Center, New York
Georgetown University Medical Center, Washington D.C.
University of North Carolina, Chapel Hill
University of Alabama at Birmingham (UAB), Birmingham
Vanderbilt University, Nashville
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis
University of Michigan Comprehensive Cancer Center, Ann Arbor
University of Chicago, Chicago
Baylor University, Houston
Dana Farber Cancer Center Institute, Boston
Collaborators (1)
Susan G. Komen Breast Cancer Foundation
OTHER
Daiichi Sankyo UK Ltd.
OTHER
Triple Negative Breast Cancer Foundation
UNKNOWN
University of Alabama at Birmingham
OTHER