A Phase II Clinical Trial of Four Cycles of Doxorubicin andCyclophosphamide Followed by Weekly Paclitaxel GivenConcurrently With Pazopanib as Neoadjuvant Therapy Followedby Postoperative Pazopanib for Women With Locally AdvancedBreast Cancer
This is a phase II non-randomized, multi-center study aimed to evaluate the efficacy and
safety of the combination of pazopanib and paclitaxel following treatment with
cyclophosphamide and doxorubicin for the treatment of neoadjuvant breast cancer.
Patients will receive standard doses of AC every 21 days for 4 cycles. This will be followed
by weekly paclitaxel 80 mg/m2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given
concurrently with pazopanib 800 mg PO daily starting with the first paclitaxel dose and
continuing until 7 days before surgery. Clinical complete response rate will be determined
by tumor assessments performed by palpation at two time points: following AC (before
paclitaxel/pazopanib begins) and 2-4 weeks following the last dose of paclitaxel (before
surgery). Following recovery from preoperative therapy, patients will undergo the
clinically-indicated surgery. Pazopanib will resume 4-6 weeks after surgery and continue
daily for 6 months of postoperative pazopanib therapy.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Pathologic Complete Response (pCR) in the Breast and Nodes
pCR was defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy.
From the start of the study until the time of surgery (average of 221.9 days [standard deviation of 23.65 days] after study entry)
No
GSK Clinical Trials
Study Director
GlaxoSmithKline
Canada: Health Canada
110264
NCT00849472
July 2009
April 2013
Name | Location |
---|---|
GSK Investigational Site | Bakersfield, California 93309 |
GSK Investigational Site | Gainesville, Florida 32610 |
GSK Investigational Site | Duluth, Minnesota 55805 |
GSK Investigational Site | Raleigh, North Carolina 27609 |
GSK Investigational Site | Fort Worth, Texas 76104 |
GSK Investigational Site | Green Bay, Wisconsin 54301 |
GSK Investigational Site | Bettendorf, Iowa 52722 |
GSK Investigational Site | Royal Oak, Michigan 48073 |
GSK Investigational Site | Pittsburgh, Pennsylvania 15213 |
GSK Investigational Site | Salem, Virginia 24153 |
GSK Investigational Site | Birmingham, Alabama 35209 |
GSK Investigational Site | Aurora, Colorado 80012 |
GSK Investigational Site | Edison, New Jersey 08837 |
GSK Investigational Site | Oregon City, Oregon 97045 |
GSK Investigational Site | Seattle, Washington 98133 |