Phase 1/2Completed
Vaccination of High Risk Breast Cancer Patients - A Combined Phase I/II Feasibility-and-Efficacy Study
A Combined Phase I/II Feasibility-and-Efficacy Study of a Carbohydrate Mimotope-based Vaccine With MONTANIDE™ ISA 51 VG Combined With Neoadjuvant Chemotherapy
- Sponsor
- University of Arkansas (Academic or other)
- Enrolment
- 58 enrolled
- Conditions
- Breast Cancer; Breast Neoplasms
- Interventions
- P10s-PADRE/ MONTANIDE™ ISA 51 VG; Doxorubicin; Cyclophosphamide; Docetaxel
- Ages
- adults, older adults
- Registry
- NCT02229084
Full record on ClinicalTrials.gov
From the registry
The purpose of this study is to evaluate a new investigational cancer vaccine, P10s-PADRE in combination with standard neoadjuvant chemotherapy and surgery in patients with clinical stage I, II or III estrogen-receptor (ER)-positive, HER2-negative breast cancer.
Primary outcomes
- Identify a Feasible Schedule of Vaccination Relative to SoC Neoadjuvant Chemotherapy When the Chemovax Are Administered Concurrently.
- Determine the pCR Rate
History
Last registry update
Results first posted
Primary completion
Started
Registered