32
Participants
Start Date
July 31, 2009
Primary Completion Date
May 31, 2014
Study Completion Date
August 31, 2017
nab-paclitaxel
100 MG/M2 IV over 30 minutes once a week for 12 weeks
trastuzumab
4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks
Doxorubicin
60 MG/M2 every two weeks for a total of 4 cycles
cyclophosphamide
600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)
Growth Factor Support
"* All patients will receive pegfilgrastim 6.0 mg sc on Day #2 of each doxorubicin/cyclophosphamide neoadjuvant treatment cycle.~* Erythropoetic growth factor support for fatigue/anemia will be allowed at the discretion of the treating physician."
Surgery
"* After completion of neoadjuvant therapy, patients will proceed with either modified radical mastectomy or lumpectomy.~* All patients with pretreatment lymph node positive disease and positive sentinel lymph node will undergo complete axillary lymph node dissection."
University of Kansas Medical Center Cancer Center, Kansas City
Hays Medical Center, Hays
Collaborators (1)
Celgene Corporation
INDUSTRY
University of Kansas Medical Center
OTHER