58
Participants
Start Date
January 14, 2015
Primary Completion Date
January 3, 2023
Study Completion Date
January 3, 2023
P10s-PADRE/ MONTANIDE™ ISA 51 VG
Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions concurrent with chemotherapy.
Doxorubicin
Doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) (AC) will be administered concurrently every three weeks for four cycles followed by docetaxel (75 mg/m2) every three weeks for four cycles.
Cyclophosphamide
Doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) (AC) will be administered concurrently every three weeks for four cycles followed by docetaxel (75 mg/m2) every three weeks for four cycles.
Docetaxel
"Doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) (AC) will be administered concurrently every three weeks for four cycles followed by docetaxel (75 mg/m2) every three weeks for four cycles.~If docetaxel is not tolerated, paclitaxel (175mg/m2) may be used in its place."
University of Arkansas for Medical Sciences, Little Rock
Highlands Oncology Group, Fayetteville
University of Arkansas
OTHER