Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT05163223
- Lead Sponsor
- Aston Sci. Inc.
- Brief 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).
- Detailed Description
Not provided
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
- Has a residual invasive cancer in the breast(non-pCR) after neoadjuvant treatment
- Has stage I, II, or III disease prior to surgery per American Joint Committee on Cancer (AJCC)
- HER 2 1+ by IHC or HER2 2+by IHC without gene amplification by ISH, as defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
- Hormone receptor (ER and PR) negative by ASCO/CAP guidelines
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Demonstrates adequate organ function.
Key
- Has a history of hypersensitivity or other contraindications to rhGM-CSF
- Has a history of invasive malignancy ≤5 years prior to first administration of investigational drug except for adequately treated non-melanoma skin cancer or carcinoma in situ.
- Is on immune suppression therapy or has a history of immune suppression therapy ≤4 weeks prior to the first administration of investigational drugs
- Has a history of autoimmune disease or inflammatory disease
- Has active infection including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
- Is pregnant or breastfeeding or expecting to conceive children
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo + Chemotherapy rhuGM-CSF * Placebo/rhuGM-CSF (q 3 weeks, 3 cycles) + Standard adjuvant therapy\* * A booster (Placebo/rhuGM CSF) at 24 weeks post the third vaccination * Standard adjuvant therapy will be pembrolizumab or capecitabine (q 3 weeks) AST-301(pNGVL3-hICD)+Chemotherapy AST-301(pNGVL3-hICD) * AST-301/rhuGM-CSF (q 3 weeks, 3 cycles) + Standard adjuvant therapy\* * A booster (AST-301/rhuGM-CSF) at 24 weeks post the third vaccination * Standard adjuvant therapy will be pembrolizumab or capecitabine (q 3 weeks) AST-301(pNGVL3-hICD)+Chemotherapy rhuGM-CSF * AST-301/rhuGM-CSF (q 3 weeks, 3 cycles) + Standard adjuvant therapy\* * A booster (AST-301/rhuGM-CSF) at 24 weeks post the third vaccination * Standard adjuvant therapy will be pembrolizumab or capecitabine (q 3 weeks) Placebo + Chemotherapy Placebo * Placebo/rhuGM-CSF (q 3 weeks, 3 cycles) + Standard adjuvant therapy\* * A booster (Placebo/rhuGM CSF) at 24 weeks post the third vaccination * Standard adjuvant therapy will be pembrolizumab or capecitabine (q 3 weeks) AST-301(pNGVL3-hICD)+Chemotherapy Capecitabine * AST-301/rhuGM-CSF (q 3 weeks, 3 cycles) + Standard adjuvant therapy\* * A booster (AST-301/rhuGM-CSF) at 24 weeks post the third vaccination * Standard adjuvant therapy will be pembrolizumab or capecitabine (q 3 weeks) AST-301(pNGVL3-hICD)+Chemotherapy Pembrolizumab * AST-301/rhuGM-CSF (q 3 weeks, 3 cycles) + Standard adjuvant therapy\* * A booster (AST-301/rhuGM-CSF) at 24 weeks post the third vaccination * Standard adjuvant therapy will be pembrolizumab or capecitabine (q 3 weeks) Placebo + Chemotherapy Pembrolizumab * Placebo/rhuGM-CSF (q 3 weeks, 3 cycles) + Standard adjuvant therapy\* * A booster (Placebo/rhuGM CSF) at 24 weeks post the third vaccination * Standard adjuvant therapy will be pembrolizumab or capecitabine (q 3 weeks) Placebo + Chemotherapy Capecitabine * Placebo/rhuGM-CSF (q 3 weeks, 3 cycles) + Standard adjuvant therapy\* * A booster (Placebo/rhuGM CSF) at 24 weeks post the third vaccination * Standard adjuvant therapy will be pembrolizumab or capecitabine (q 3 weeks)
- Primary Outcome Measures
Name Time Method 2-year invasive disease free survival rate (iDFS) Overall study period approximately up to 4years (End of study in this study is defined as 2years frm the date of last Patient In. iDFS event is defined as Ipsilateral breast tumor recurrence Local/regional invasive recurrence Distant recurrence Invasive contralateral breast cancer Death (from breast cancer/non-breast cancer cause/unknown cause) Secondary primary invasive cancer (non-breast)
- Secondary Outcome Measures
Name Time Method Change in central memory T cell populations Up to approximately 82 weeks Assessment by FACS
Number of participants with treatment-related adverse events as assessed by CTCAE Overall study period approximately up to 4years To assess safety of AST-301 administered in breast cancer patients.
Distant Recurrence-Free Survival rate, dRFS rate Overall study period approximately up to 4 years dRFS rate at the end of study
AST-301 specific T cell immune responses Up to approximately 82 weeks Immune response will be assessed by IFN-gamma enzyme-linked immune absorbent spot (ELISpot) assay
Trial Locations
- Locations (17)
Ironwood Cancer and Research Centers
🇺🇸Chandler, Arizona, United States
Scripps Health
🇺🇸La Jolla, California, United States
China Medical University Hospital
🇨🇳Taichung City, Taiwan
University of Illinois Cancer Center
🇺🇸Chicago, Illinois, United States
The Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
Gabrail Cancer Center Research
🇺🇸Canton, Ohio, United States
University of Washington
🇺🇸Seattle, Washington, United States
Changhua Christian Hospital
🇨🇳Changhua City, Taiwan
Chi Mei Medical Center
🇨🇳Tainan, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Nebraska Cancer Specialist
🇺🇸Omaha, Nebraska, United States
Providence Cancer Institute
🇺🇸Portland, Oregon, United States
Toledo Clinic Cancer Center
🇺🇸Toledo, Ohio, United States
Koo Foundation Sun Yat-Sen Cancer Center
🇨🇳Taipei city, Taiwan
National Taiwan University Hospital
🇨🇳Taipei City, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei City, Taiwan