Vaccination of High Risk Breast Cancer Patients

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

January 14, 2015

Primary Completion Date

January 3, 2023

Study Completion Date

January 3, 2023

Conditions
Breast CancerBreast Neoplasms
Interventions
BIOLOGICAL

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.

DRUG

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.

DRUG

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.

DRUG

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."

Trial Locations (2)

72205

University of Arkansas for Medical Sciences, Little Rock

72703

Highlands Oncology Group, Fayetteville

All Listed Sponsors
lead

University of Arkansas

OTHER

NCT02229084 - Vaccination of High Risk Breast Cancer Patients | Biotech Hunter | Biotech Hunter