Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Breast Cancer
In brief
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).
Key facts
- Study ID
- NCT05163223
- Run by
- Aston Sci. Inc.
- People needed
- 10
- Starts
- 2022-02-28
- Expected to finish
- 2024-05-31
- Last updated by the study team
- 2024-06-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Ironwood Cancer and Research Centers — Chandler, Arizona, United States
- Scripps Health — La Jolla, California, United States
- Moffitt Cancer Center — Tampa, Florida, United States
- University of Illinois Cancer Center — Chicago, Illinois, United States
- Nebraska Cancer Specialist — Omaha, Nebraska, United States
- Gabrail Cancer Center Research — Canton, Ohio, United States
- The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
- Toledo Clinic Cancer Center — Toledo, Ohio, United States
- Providence Cancer Institute — Portland, Oregon, United States
- University of Washington — Seattle, Washington, United States
- Changhua Christian Hospital — Changhua, Taiwan
- Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan
- China Medical University Hospital — Taichung, Taiwan
- Chi Mei Medical Center — Tainan, Taiwan
- Koo Foundation Sun Yat-Sen Cancer Center — Taipei, Taiwan
- National Taiwan University Hospital — Taipei, Taiwan
- Taipei Veterans General Hospital — Taipei, Taiwan
Full record on ClinicalTrials.gov
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