Study: NCT02229084

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: P10s-PADRE/ MONTANIDE™ ISA 51 VG
Description: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions concurrent with chemotherapy.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: P10s-PADRE/ MONTANIDE™ ISA 51 VG
Description: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions concurrent with chemotherapy.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: P10s-PADRE/ MONTANIDE™ ISA 51 VG
Description: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions concurrent with chemotherapy.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: P10s-PADRE/ MONTANIDE™ ISA 51 VG
Description: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions concurrent with chemotherapy.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: P10s-PADRE/ MONTANIDE™ ISA 51 VG
Description: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions concurrent with chemotherapy.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: P10s-PADRE/ MONTANIDE™ ISA 51 VG
Description: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions concurrent with chemotherapy.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: P10s-PADRE/ MONTANIDE™ ISA 51 VG
Description: Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions concurrent with chemotherapy.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Docetaxel
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Docetaxel
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Docetaxel
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Docetaxel
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Docetaxel
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Docetaxel
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Docetaxel
Description: 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.