Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer
Status:
Not yet recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the efficacy and safety of an adjuvant treatment of
therapeutic cancer vaccine (AST-301, pNGVL3-hICD) in patients with HER2-low expression (IHC
1+ or 2+ and ISH-) and hormone receptor-negative(ER-, PR-) breast cancer with residual
disease after neoadjuvant treatment.
Patients will be randomized 1:1 to either the Experimental arm (combination of AST-301/rhuGM
CSF and standard adjuvant therapy) or the Control arm (combination of placebo/rhuGM CSF and
standard adjuvant therapy). Standard adjuvant chemotherapy will be pembrolizumab or
capecitabine.
Adjuvant therapy will be administered in compliance with the NCCN guideline for breast cancer
(Version 8, 2021), and IP (AST-301) will be administered 3 times every 3 weeks in the
adjuvant treatment period, with a booster administered at 24 weeks (±7 days) post the third
dose of IP administration.
Survival follow up will be performed to determine invasive Disease Free survival(iDFS).